Entities / Company
FDA.
Company
- Reports this week
- 68
- Active events
- 60+
- Connections
- 3,150
What's happening
Reports per dayLast 90 days
90 days agoDrag either end to show only events that began in that periodToday
Active this week
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Unicycive Therapeutics, Inc. is facing investigator findings regarding manufacturing compliance issues from the FDA.Some support8 reports
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EWG reported that 99% of chemicals have avoided FDA scrutiny, highlighting issues with regulatory oversight.Some support1 report1 development inside
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OEHHA is questioning the FDA regarding the safety levels of dyes.Some support1 report
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Vystar is strategically focusing on R3ALM Financial Ecosystem, and its RXAIR assets include FDA Class II devices.Some support2 reports
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FDA granted Orphan Drug Designation to BRC's drug.Some support1 report
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OCS is seeking Priority Medicines and Breakthrough Therapy designations for Privosegtor for optic neuritis from the FDA and EMA.Some support2 reports1 development inside
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The FDA is currently reviewing concerns regarding mail-order abortion pills and the circulation of mifepristone.Well supported6 reports1 development inside
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FDA issued an Early Alert regarding product safety involving B. Braun.Some support1 report
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Takeda is seeking FDA approval for its drug ORZEYFUL.Well supported10 reports
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An integrated GLP-1 program is utilizing medications that have received approval from the FDA.Some support1 report1 development inside
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Amidst panel votes, Robert F. Kennedy Jr. seeks to overturn FDA restrictions regarding peptides, while critics question safety data.Well supported24 reports1 development inside
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Replimune Group, Inc. received accelerated approval for TUDRIQEV™ in advanced melanoma, while its stock price reflected quarterly EPS misses.Some support2 reports
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Lew questioned the FDA regarding the underreporting of cancer cases.Some support1 report
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The FDA granted Orphan Drug Designation to sovleplenib, a drug associated with HUTCHMED, which operates in China.Some support1 report
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Mesoblast is seeking FDA review of the BLA for its product rexlemestrocel-L.Some support3 reports1 development inside
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HHS policy allows peptides in compounding pharmacies despite FDA lack of approval, with RFK Jr. arguing for safer compounds.Well supported13 reports
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The National Center for PTSD provides data on PTSD in the US while university researchers develop FDA-cleared treatments.Some support1 report
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FDA approved a medical device from Abbott and supported a PARADIGM study based on data from the Cleveland Clinic.Some support1 report
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Beta Bionics, Inc. is accused of failing to accurately describe observations made by the FDA.Some support16 reports1 development inside
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HHS and FDA are investigating industry donations and issuing warnings regarding policy and substance classification.Some support1 report1 development inside
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The illegal U.S. vape market is estimated to be worth $9 billion, fueled by unauthorized imports from China, while products must meet FDA authorization standards.Well supported3 reports1 development inside
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VDPHL01 and Veradermics, Incorporated are seeking FDA approval for their lead therapies targeting hair loss.Some support1 report1 development inside
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The FDA (Q11200607) and the Food Safety and Standards Authority of India (Q5465383) are involved in a new development regarding the governance of inspections.Some support2 reports2 developments inside
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FDA conducted surprise raids and inspections in Bihar state, directed by state government officials.Some support1 report
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FDA conducted widespread seizures of prohibited food items and products across Pune, Nashik, Mumbai, Konkan, and Nanded.Some support2 reports
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The FDA reviewed risks and loosened the label on testosterone replacement therapy (TRT) following an attempt by the Trump administration to reverse its decline.Well supported4 reports2 developments inside
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PAVmed is facing the requirement of regulatory clearance for its company products, while also attracting institutional investment interest.Some support3 reports
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FDA conducted inspections in Patiala, leading to allegations of harassment by state authorities against a local chemists association.Some support1 report
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BMD is listed on Nasdaq and received positive feedback from the FDA regarding its Phase 3 drug protocol.Some support2 reports
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FDA took food safety action, including license suspensions, across multiple cities in Maharashtra.Well supported7 reports3 developments inside
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The Food and Drug Administration (FDA) oversees product safety and recalls.Some support2 reports2 developments inside
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The FDA has listed recalled products, involving the company Colgate.Some support1 report
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Parabilis Medicines debuted on Nasdaq, achieving IPO haul surpassing Moderna's, while its product received FDA fast-track designation. Regeneron also acquired shares.Some support1 report1 development inside
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Parabilis reached alignment with the FDA on the dose and regimen of its drug.Some support1 report
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Chris Carr, Georgia Attorney General, seeks stricter state laws following FDA warnings about kratom.Well supported4 reports
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The FDA approved a Skyrizi regimen for Crohn's disease, based on an AFFIRM trial led by UNC.Some support1 report
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The FDA approved Edwards' PASCAL Precision system, which is the sole provider of these therapies in the US.Some support1 report
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FDA rejected a drug application due to inadequate data, with Frances Kelsey involved in the review.Some support1 report
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The FDA classified the recall of Great Value items, which were distributed in New Mexico, Louisiana, Alabama, and Pennsylvania.Some support1 report
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United Therapeutics completed facility construction in Minnesota and Texas and submitted an NDA to the FDA.Well supported3 reports
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The FDA's GRAS status allows supplements to bypass full review, a point targeted by Kennedy and analyzed by experts like Professor Cohen, involving Calley Means and Harvard Medical School.Well supported3 reports1 development inside
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Waters Corporation and LabCorp are partnering to expand access to FDA-approved HPV testing options.Some support1 report
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BDR Pharmaceuticals filed a lawsuit challenging FDA decisions related to Phathom Pharmaceuticals' drug applications.Some support1 report
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Lawsuits filed in Seattle involve FDA oversight, while the FDA investigates food safety issues in New Jersey.Some support1 report
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FDA approval supports NDA submission in Aurora.Some support1 report
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Vera Therapeutics and the FDA agreed to shift the assessment of a clinical study.Some support1 report
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Eli Lilly and Company received full FDA approval, expanded a safety study into India, and broke ground on a new facility in Houston while competing in the GLP-1 market.Some support2 reports1 development inside
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Moderna and Merck are seeking FDA review for a novel cancer treatment, having co-led a Phase 3 mRNA vaccine trial.Well supported14 reports2 developments inside
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FDA, LabCorp, and Charles River Laboratories formed a collaboration to evaluate the potential for medicine abuse.Some support1 report
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SBE303 received Fast Track designation from the FDA, involving the African Democratic Congress.Some support1 report
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Arthur Caplan questioned the FDA regarding the status of clinical trials in 2006.Some support1 report
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Argenx SE announced it is listed on Nasdaq and is seeking FDA priority review and approval.Some support1 report
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FDA approved a new cancer drug in Massachusetts on October 21, 2026.Some support1 report
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Regulatory violations led to the suspension of a license by the FDA in Mumbai.Some support2 reports
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FDA confirmed CMC and device plans are Phase 3 ready, coinciding with strengthening of US and EU patent estates.Some support2 reports
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FDA granted clearance for DVT treatment involving Penumbra, Inc.Some support1 report
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The DEA opposed a motion before Chief Administrative Law Judge Julius, noting that both agencies lack comprehensive scheduling policies.Some support9 reports
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The FDA cited Procter & Gamble for deviations from CGMP regulations related to the manufacturing of Crest children's toothpaste.Some support1 report
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FDA communicated eligibility for accelerated approval for ProKidney Corp., which plans to present study results at ASN.Well supported4 reports1 development inside
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BMS, Eli Lilly, and Novo Nordisk are advancing GLP-1 portfolios, investing in manufacturing, and navigating regulatory approvals.Some support1 report
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What's reaching FDA
Events traced to FDA, step by step, newest first- Sanofi's new vaccine development requires FDA regulatory oversightSanofi's new vaccine development requires FDA regulatory oversightPossible
- Vaccine deal talks in Brussels may prompt FDA regulatory reviewPolitical discussions over vaccine deals may prompt the FDA to review regulatory standards.Possible
- Legislative pressure may change FDA pathways for new antibioticsLegislative pressure may change FDA pathways for new antibioticsPossible
- New cancer treatment collaboration increases regulatory pipeline for FDAThe collaboration on new cancer therapies could increase the FDA's regulatory review pipeline.Possible
- FDA focus shifts to Catalyst Pharmaceuticals for AGAMREEFDA regulatory focus shifts to Catalyst Pharmaceuticals for AGAMREE in North AmericaLikely
- FDA may accelerate review of new mRNA cancer vaccineThe FDA may accelerate review of new mRNA cancer vaccine after landmark trial successLikely
See all 30 explainers
- AbbVie's acquisition may increase FDA drug application volumeAbbVie's pipeline expansion could increase the volume of drug applications reviewed by the FDA.Possible
- Akeso's US trial expansion brings ivonescimab under FDA reviewUS clinical trial expansion increases FDA oversight of ivonescimab.Likely
- Labcorp's new prenatal testing services may require FDA oversightLabcorp's expanded prenatal testing portfolio may require FDA reviewPossible
- Blocked NIH grants could slow FDA's regulatory reviewBlocked NIH research grants may slow FDA regulatory reviewPossible
- OCS's positive trial data may influence FDA review of PrivosegtorOCS's positive trial data may influence FDA review of PrivosegtorPossible
- Senate race could influence FDA regulations and healthcare policyA change in the Senate seat could influence FDA regulations and healthcare policyPossible
- FDA may coordinate with NIH on new women's health researchFDA may face increased regulatory coordination due to NIH's new research focusPossible
- Licaminlimab trial data could influence FDA's regulatory pathPositive clinical trial data could accelerate FDA review of Licaminlimab.Possible
- Marijuana rescheduling may alter FDA's drug approval oversightMarijuana rescheduling could change the regulatory framework overseen by the FDA.Possible
- FDA may review new Moderna-Merck combination drugFDA must evaluate new Moderna-Merck combination drug for melanoma treatmentPossible
- New GLP-1 research could prompt FDA review of drug pathwaysNew findings on GLP-1 drugs may prompt FDA regulatory reviewPossible
- How could the CDPH's shellfish closure affect the FDA's regulatory review process?Local shellfish contamination may inform federal food safety review processPossible
- FDA may face increased review after Guidant acquisitionFDA may face increased regulatory review following Guidant's acquisitionPossible
- Aro Biotherapeutics' data could influence FDA review of T1D drugPositive preclinical data may increase the FDA's interest in Centyrin-IFIH1 siRNA.Possible
- Funding cuts could strain FDA's ability to oversee treatmentsWeakening medical research infrastructure may compromise FDA's regulatory oversightPossible
- Embryo research ban may limit FDA's future product pipelineFDA's regulatory pipeline could be limited by restrictions on embryo researchPossible
- Liquidia settlement requires FDA to update Yutrepia's approved labelThe FDA must update Yutrepia's approved label following Liquidia's settlementLikely
- FDA may face increased demand from advanced biologic pipelineFDA may face increased demand to review complex, AI-driven biologic submissionsPossible
- Moderna/Merck cancer vaccine success increases FDA review workloadFDA faces increased regulatory demand from advanced cancer vaccine trialsPossible
- Zenas's positive clinical data may influence FDA review of obexelimabThe positive clinical data from Zenas could strengthen the FDA's review of obexelimab.Possible
- Doge's cuts may reshape FDA staffing and policyDoge's cuts may reshape FDA staffing and policyLikely
- Arvinas' positive Phase 1 data may strengthen FDA review of LRRK2 drugArvinas' positive Phase 1 data may strengthen FDA review of LRRK2 drug.Possible
- Moderna's cancer vaccine result boosts FDA approval chancesLandmark cancer vaccine study increases probability of FDA approval for Moderna/Merck therapyLikely
- AI-driven drug discovery may force FDA to adapt regulatory frameworksAI-driven drug discovery may force FDA to adapt regulatory frameworksPossible
Explainers that pass through FDA
FDA is a step on the way to someone else- Walmart must remove six lots of recalled frozen berriesWalmart must remove six lots of recalled frozen berries from shelvesReported
- Mumbai Food Establishments Face License Suspension Due to FDA DriveFDA suspends and cancels licenses of multiple food establishments in MumbaiReported
- Apple leverages FDA clearance for health features in Apple WatchApple secures FDA clearance for ECG and atrial fibrillation featuresIncludes Brind's reasoning
- How does FDA and EMA sharing global regulatory leadership affect company?FDA and EMA collaboration supports OS Therapies' global market access strategyReported
Around FDA this week
News at the entities that move FDA most-
United States of America StructuralFu Cong urged the United States to end the economic blockade against Cuba during a UN General Assembly debate.Moves FDA
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Louisiana OperationalLouisiana, Oklahoma, Texas, and Arkansas states hold elections with key deadlines on October 27, 2026.Moves FDA
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Congress StructuralDemocrats are vying for control of Congress, with political figures from Ohio, Iowa, and Texas being mentioned.Moves FDA
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Florida OperationalSimilar constitutional amendments were passed in both Colorado and Florida on October 29, 2026.Moves FDA
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Merck KGaA OperationalBioinvent presented data combining its BI-1808 therapy with MSD's KEYTRUDA® at the ESMO Congress in Madrid.Moves FDA
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Robert F. Kennedy Jr. OperationalRobert F. Kennedy Jr. served as health secretary for HHS and was involved in FDA leadership decisions.Moves FDA
Connections
The 40 strongest of 3,150, analyzed from the reporting. The bars show how strongly a change on one side reaches the other.-
United States of America Structural
The FDA is a regulatory agency whose existence, authority, and operational scope are formally derived from the United States government.
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Center for Devices and Radiological Health Structural
CDRH functions as a formal division of the FDA, issuing alerts and holding meetings under its designation.
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Eli Lilly and Company Structural
The FDA formally regulates Eli Lilly's drug development, approval, and market activities, determining product viability and market access.
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Louisiana Operational
Louisiana actively challenges federal drug policies and regulations enforced by the FDA through ongoing litigation.
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Heidi Overton Structural
Heidi Overton is appointed to the formal leadership role of the FDA Commissioner.
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Congress Structural
The FDA's regulatory scope, funding, and operational mandates are established and controlled by legislation and oversight from Congress.
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Florida Operational
FDA and Florida engage in a dynamic regulatory relationship, characterized by federal standards setting and state legislative and litigation challenges.
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Tukaram Mundhe Structural
Tukaram Mundhe holds the formal position of Commissioner, directing the regulatory and enforcement operations of the FDA Maharashtra.
Show all 40 connections
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Center for Biologics Evaluation and Research Structural
CBER is a specialized research center that operates as a division under the authority of the FDA.
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Center for Drug Evaluation and Research Structural
The Center for Drug Evaluation and Research is a formal division overseen by the FDA agency.
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Drug Enforcement Administration Operational
The FDA and DEA maintain a formal regulatory partnership, jointly overseeing substance scheduling, clinical trials, and market safety.
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Robert F. Kennedy Jr. Operational
As HHS Secretary, Robert F. Kennedy Jr. exerts significant political influence over the FDA's policy direction and operational focus.
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Philip Morris International Structural
The FDA formally regulates and authorizes the marketing and products of Philip Morris International.
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Intuitive Surgical Structural
The FDA functions as the mandatory regulatory gatekeeper, granting market access and operational legitimacy to Intuitive Surgical's medical devices.
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Office of Management and Budget Structural
The Office of Management and Budget formally reviews and oversees the rulemaking and approval processes of the FDA.
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Neuralink Structural
Neuralink's commercialization and device status are formally dependent on regulatory approval from the FDA.
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Sanofi Structural
The FDA formally evaluates, grants market access designations, and approves Sanofi's pharmaceutical products for use in the United States.
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Abbott Laboratories Structural
The FDA regulates Abbott Laboratories, granting product approvals, setting operational standards, and conducting oversight.
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Vinay Prasad Structural
Vinay Prasad holds a high-ranking leadership role within the FDA, specifically overseeing the critical CBER division and gene therapy review processes.
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Medicare Operational
FDA clearance enables Medicare coverage, but Medicare rules actively restrict access, reimbursement, and pricing for approved products.
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Michael Davis Structural
Michael Davis was appointed to lead a key drug evaluation center within the FDA.
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MannKind Corporation Structural
MannKind Corporation's market access and product lifecycle are governed by the formal regulatory oversight and approval processes of the FDA.
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Masimo Structural
The FDA acts as the regulatory gatekeeper, granting necessary clearances for Masimo's patient monitoring technologies to enter the market.
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Natera Structural
Natera relies on the FDA for market access, which evaluates and grants approval for its products as a companion diagnostic.
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Iovance Biotherapeutics Structural
The FDA formally regulates and grants market approval to Iovance Biotherapeutics' therapeutic products.
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WuXi Biologics Structural
FDA formally inspects and regulates WuXi Biologics' manufacturing facilities to ensure compliance.
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Bill Cassidy Operational
Bill Cassidy actively scrutinizes, pressures, and urges the FDA regarding drug policy, safety standards, and regulatory compliance through his official capacity.
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ADC Therapeutics Structural
ADC Therapeutics' drug development and commercial status are fundamentally governed by regulatory actions and approvals from the FDA.
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Boston Scientific Structural
The FDA regulates Boston Scientific through market approvals, safety monitoring, and required alerts.
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CRISPR Therapeutics Structural
The FDA formally regulates and approves CRISPR Therapeutics' gene-editing treatments.
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Penumbra Structural
The FDA formally regulates Penumbra, requiring product clearances and imposing oversight models for market access.
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BridgeBio Structural
BridgeBio relies on the FDA's regulatory review and approval processes to gain market access for its pharmaceutical products.
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Lyell Immunopharma (United States) Structural
The FDA formally regulates Lyell Immunopharma's product development by granting designations such as RMAT and Fast Track.
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Centers for Disease Control and Prevention Structural
The CDC and FDA maintain a structural partnership, coordinating outbreak responses and relying on FDA approval for vaccine recommendations.
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Atrium Structural
Atrium received Investigational New Drug (IND) clearance from the FDA for ATR 1072.
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Rocket Structural
The FDA formally regulates Rocket's drug development, issuing clearances, designations, and clinical holds.
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AbbVie Structural
The FDA formally regulates and grants market approvals and designations for AbbVie's pharmaceutical products.
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Dexcom Structural
FDA formally regulates Dexcom's manufacturing processes and grants market clearance for its medical devices.
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Merck KGaA Operational
The FDA evaluates and approves pharmaceutical products submitted by Merck KGaA, granting market access based on rigorous review processes.
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Jazz Pharmaceuticals Structural
Jazz Pharmaceuticals relies on the FDA for regulatory approval, which is required for market introduction and sales of its therapies.
History
Events by the month they beganOctober 2026
34 events- OEHHA is questioning the FDA regarding the safety levels of dyes.
- FDA granted Orphan Drug Designation to BRC's drug.
- FDA issued an Early Alert regarding product safety involving B. Braun.
- Lew questioned the FDA regarding the underreporting of cancer cases.
- The FDA granted Orphan Drug Designation to sovleplenib, a drug associated with HUTCHMED, which operates in China.
- HHS policy allows peptides in compounding pharmacies despite FDA lack of approval, with RFK Jr. arguing for safer compounds.
- The National Center for PTSD provides data on PTSD in the US while university researchers develop FDA-cleared treatments.
- FDA approved a medical device from Abbott and supported a PARADIGM study based on data from the Cleveland Clinic.
- VDPHL01 and Veradermics, Incorporated are seeking FDA approval for their lead therapies targeting hair loss.
- FDA conducted surprise raids and inspections in Bihar state, directed by state government officials.
- FDA conducted widespread seizures of prohibited food items and products across Pune, Nashik, Mumbai, Konkan, and Nanded.
- FDA conducted inspections in Patiala, leading to allegations of harassment by state authorities against a local chemists association.
- The FDA has listed recalled products, involving the company Colgate.
- Parabilis reached alignment with the FDA on the dose and regimen of its drug.
- Chris Carr, Georgia Attorney General, seeks stricter state laws following FDA warnings about kratom.
- The FDA approved a Skyrizi regimen for Crohn's disease, based on an AFFIRM trial led by UNC.
- The FDA approved Edwards' PASCAL Precision system, which is the sole provider of these therapies in the US.
- FDA rejected a drug application due to inadequate data, with Frances Kelsey involved in the review.
- The FDA classified the recall of Great Value items, which were distributed in New Mexico, Louisiana, Alabama, and Pennsylvania.
- Waters Corporation and LabCorp are partnering to expand access to FDA-approved HPV testing options.
- BDR Pharmaceuticals filed a lawsuit challenging FDA decisions related to Phathom Pharmaceuticals' drug applications.
- Lawsuits filed in Seattle involve FDA oversight, while the FDA investigates food safety issues in New Jersey.
- FDA approval supports NDA submission in Aurora.
- Vera Therapeutics and the FDA agreed to shift the assessment of a clinical study.
- FDA, LabCorp, and Charles River Laboratories formed a collaboration to evaluate the potential for medicine abuse.
- SBE303 received Fast Track designation from the FDA, involving the African Democratic Congress.
- Arthur Caplan questioned the FDA regarding the status of clinical trials in 2006.
- Argenx SE announced it is listed on Nasdaq and is seeking FDA priority review and approval.
- FDA approved a new cancer drug in Massachusetts on October 21, 2026.
- Regulatory violations led to the suspension of a license by the FDA in Mumbai.
- FDA granted clearance for DVT treatment involving Penumbra, Inc.
- The DEA opposed a motion before Chief Administrative Law Judge Julius, noting that both agencies lack comprehensive scheduling policies.
- The FDA cited Procter & Gamble for deviations from CGMP regulations related to the manufacturing of Crest children's toothpaste.
- BMS, Eli Lilly, and Novo Nordisk are advancing GLP-1 portfolios, investing in manufacturing, and navigating regulatory approvals.
September 2026
6 events- Unicycive Therapeutics, Inc. is facing investigator findings regarding manufacturing compliance issues from the FDA.
- Vystar is strategically focusing on R3ALM Financial Ecosystem, and its RXAIR assets include FDA Class II devices.
- Beta Bionics, Inc. is accused of failing to accurately describe observations made by the FDA.
- The FDA (Q11200607) and the Food Safety and Standards Authority of India (Q5465383) are involved in a new development regarding the governance of inspections.
- PAVmed is facing the requirement of regulatory clearance for its company products, while also attracting institutional investment interest.
- Eli Lilly and Company received full FDA approval, expanded a safety study into India, and broke ground on a new facility in Houston while competing in the GLP-1 market.
August 2026
9 events- EWG reported that 99% of chemicals have avoided FDA scrutiny, highlighting issues with regulatory oversight.
- Takeda is seeking FDA approval for its drug ORZEYFUL.
- Replimune Group, Inc. received accelerated approval for TUDRIQEV™ in advanced melanoma, while its stock price reflected quarterly EPS misses.
- HHS and FDA are investigating industry donations and issuing warnings regarding policy and substance classification.
- FDA took food safety action, including license suspensions, across multiple cities in Maharashtra.
- The Food and Drug Administration (FDA) oversees product safety and recalls.
- United Therapeutics completed facility construction in Minnesota and Texas and submitted an NDA to the FDA.
- Moderna and Merck are seeking FDA review for a novel cancer treatment, having co-led a Phase 3 mRNA vaccine trial.
- FDA confirmed CMC and device plans are Phase 3 ready, coinciding with strengthening of US and EU patent estates.
Show 2 earlier months
July 2026
4 events- OCS is seeking Priority Medicines and Breakthrough Therapy designations for Privosegtor for optic neuritis from the FDA and EMA.
- An integrated GLP-1 program is utilizing medications that have received approval from the FDA.
- Amidst panel votes, Robert F. Kennedy Jr. seeks to overturn FDA restrictions regarding peptides, while critics question safety data.
- Mesoblast is seeking FDA review of the BLA for its product rexlemestrocel-L.
June 2026
7 events- The FDA is currently reviewing concerns regarding mail-order abortion pills and the circulation of mifepristone.
- The illegal U.S. vape market is estimated to be worth $9 billion, fueled by unauthorized imports from China, while products must meet FDA authorization standards.
- The FDA reviewed risks and loosened the label on testosterone replacement therapy (TRT) following an attempt by the Trump administration to reverse its decline.
- BMD is listed on Nasdaq and received positive feedback from the FDA regarding its Phase 3 drug protocol.
- Parabilis Medicines debuted on Nasdaq, achieving IPO haul surpassing Moderna's, while its product received FDA fast-track designation. Regeneron also acquired shares.
- The FDA's GRAS status allows supplements to bypass full review, a point targeted by Kennedy and analyzed by experts like Professor Cohen, involving Calley Means and Harvard Medical School.
- FDA communicated eligibility for accelerated approval for ProKidney Corp., which plans to present study results at ASN.