Entities / Entity
European Medicines Agency.
highest regulatory authority on medicines in the European Union
- Reports this week
- 6
- Active events
- 8
- Connections
- 119
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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Glenn attended a congress in Amsterdam and participated in a panel with an official from the European Medicines Agency.Some support1 report
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Both the FDA and the European Medicines Agency govern drug approval processes.Some support2 reports2 developments inside
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Both the FDA and European Medicines Agency must adopt evidence-based principles for drug regulation.Some support1 report
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Ascendis Pharma A/S received FDA approval and is moving forward with its first EU launch in Germany.Some support2 reports
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EMA adopted a positive opinion for Sobi's drug, with the European Commission set to confirm the decision.Some support1 report
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Omeros Corporation's drug received FDA approval and is currently undergoing review by the European Medicines Agency.Some support2 reports1 development inside
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Reports indicate Europe-wide drug shortages are occurring due to production limitations and high demand, monitored by the European Medicines Agency.Some support1 report4 developments inside
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Alvotech submitted a regulatory application to the European Medicines Agency (EMA).Some support1 report
Earlier this month
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Both the FDA and the European Medicines Agency are evaluating NervGen's lead therapeutic candidate.Some support3 reports
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Hansa Biopharma is seeking approval for its drug Idefirix in various markets, with SERB handling commercialization in EU member states.Some support4 reports1 development inside
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PolyPid Ltd's product received FDA Priority Review and gained single authorization across EU states from the EMA.Some support1 report
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Aemps was identified as Spain's national medicines watchdog.Some support1 report
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Aedes mosquitoes are spreading Chikungunya virus, leading to regulatory actions and vaccine trials involving Valneva and the EMA.Some support1 report
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IGC Pharma, Inc. is preparing data for potential U.S. FDA review and seeking EMA support for its lead drug candidate.Some support8 reports1 development inside
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Emer Cooke has been named the executive director at the European Medicines Agency (EMA).Some support1 report
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Regulatory bodies, including the EMA and FDA, are reviewing evidence regarding semaglutide and its possible association with NAION, a serious eye stroke.Some support2 reports
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WuXi Biologics received EMA approval and successfully passed FDA GMP inspection.Some support2 reports
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A company plans to submit regulatory applications to the FDA, EMA, and Australian TGA.Some support1 report
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The European Medicines Agency provided a positive opinion on a drug developed by Novartis.Some support1 report
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The FDA and European Medicines Agency discussed sharing the global regulatory leadership mantle.Some support1 report
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The European Medicines Agency is seeking a positive opinion regarding the market access for a Pertuzumab biosimilar.Some support3 reports
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Citigroup involved in global financial markets; India and Canada aiming to close CEPA trade pact; Biocon arm seeks EMA CHMP approval for drug.Some support1 report
One to three months ago
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Innate Pharma S.A. is seeking market access for its drug lacutamab in Europe, successfully achieving Breakthrough and Fast Track designations. Sobi holds the exclusive global commercialization rights.Some support1 report
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Oncopeptides AB's drug received a positive opinion from the EMA, leading to the European Commission making a final decision for the EU market.Some support1 report
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Novo Nordisk is seeking marketing authorization from the European Medicines Agency (EMA).Some support1 report
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The FDA and European Medicines Agency are harmonizing regulatory review of drug applications.Some support1 report
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The EMA has validated the Marketing Authorization Application (MAA) for a vaccine developed in collaboration between Valneva and Pfizer.Well supported6 reports1 development inside
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OS Therapies, Inc. is seeking regulatory approval from the European Medicines Agency for a new cancer treatment.Some support2 reports
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Seeking validation for next-gen pMDIs in Europe.Some support1 report
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Ascletis Pharma expects to submit its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in early 2029.Some support4 reports
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AbbVie submitted an application for the Skyrizi induction regimen to the European Medicines Agency.Some support2 reports
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EMA adopted a positive opinion and the European Commission granted marketing authorization for the drug Hopledo.Some support1 report
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AbbVie submitted an application for risankizumab approval to the European Medicines Agency.Some support1 report
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INmune Bio Inc. submitted an Orphan Drug Designation and Scientific Advice package to the European Medicines Agency.Some support2 reports
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EMA validated marketing authorization and FDA accepted NDA for Pharvaris N.V.'s lead drug.Some support2 reports
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EMA approved a drug for patient use, prompting the National Centre for Pharmacoeconomics to demand price reduction and TDs to urge reimbursement.Some support3 reports
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The European Medicines Agency is regulating market applications for pharmaceuticals while market sentiment is affected by the ongoing conflict and uncertainty in the Middle East, specifically regarding Hormuz.Some support1 report
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Both the FDA and the European Medicines Agency are reviewing deucrictibant for approval.Some support1 report
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Retatrutide lacks marketing authorization in the EU and is being used as an underground marketplace for unregulated drugs.Some support1 report
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The European Medicines Agency adopted a negative opinion on Zevra Therapeutics' MAA, while Pomerantz LLP simultaneously investigated securities fraud claims.Some support1 report
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A company is progressing its regulatory filings, utilizing a facility in Stevenage, England, with the UK filing preceding the EMA application in 2027.Some support1 report
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Fresenius Kabi received regulatory approvals from the EMA and FDA for a vedolizumab biosimilar, while excluding commercialization in the Middle East and North Africa.Some support1 report
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IMPACT Therapeutics and Pharmanovia entered an exclusive partnership for the drug senaparib, granting rights in all 27 EU member states and Australia/New Zealand.Some support3 reports
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Avantor and the Population Council expanded collaboration on an HIV prevention ring project, moving the product into regulatory review.Some support1 report
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Menarini Group and NewAmsterdam Pharma Company N.V. are collaborating on drug development, seeking marketing authorization in Europe through the EMA and EC process.Some support1 report
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The European Medicines Agency and European Commission are jointly developing Enhertu for market approval and seeking authorization in the EU.Some support2 reports
Gone quiet
No new reports in 90+ days-
A facility received EMA certification alongside ANVISA approval for market access.Some support2 reports
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The European Medicines Agency (EMA) is evaluating experimental treatments that were developed in Japan.Some support1 report1 development inside
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The European Medicines Agency reviews submissions for pharmaceutical products.Some support2 reports
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The FDA and European Medicines Agency engaged in joint coordination regarding regulatory dossier evaluation.Some support1 report1 development inside
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Hospitals in India, Israel, and the Netherlands are currently experimenting with dose reduction protocols for clinical trials under the purview of the FDA and the European Medicines Agency.Some support1 report
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The European Medicines Agency (EMA) has made a decision regarding the case-by-case use of a medicine.Some support1 report1 development inside
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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 reports
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The European Medicines Agency approved a drug change related to a Lupin facility in New Jersey, while market movements saw Infosys and Bajaj Finance fluctuate, and Thermax was listed among capital goods losers.Some support1 report
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Hansa Biopharma submitted an application for full marketing authorization to the European Medicines Agency.Some support3 reports1 development inside
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Trump-era tariffs benefit undervalued AI stocks, while AbbVie acquires Apogee Therapeutics, and regulatory applications for cemdisiran are reviewed by EMA.Some support1 report
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Oil prices eased after the Strait of Hormuz closure, while the European Medicines Agency recommended medicines for Eli Lilly.Well supported31 reports1 development inside
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Cosmos Health is establishing manufacturing licenses under European Good Manufacturing Practices and securing distribution agreements for international expansion.Some support4 reports
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The European Medicines Agency is seeking a positive opinion on ruxolitinib cream, with final approval resting with the executive branch.Some support2 reports
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Acadia Pharmaceuticals received final market authorization in the EU for its drug DAYBU after receiving a positive opinion from the European Medicines Agency.Some support3 reports
No events began in the chosen period. Widen it, or reset.
What's reaching European Medicines Agency
Events traced to European Medicines Agency, step by step, newest first- New biomarker data bolsters Privosegtor's case with EMAPositive biomarker data from ACUITY trial strengthens Privosegtor's regulatory case with EMA.Likely
- Oculis's trial data could bolster EMA review of LicaminlimabStrong clinical trial data may strengthen Oculis's regulatory application with the EMA.Possible
- Lilly's drug submissions require EMA opinion for EU market accessLilly's drug submissions require EMA opinion for EU market accessLikely
Explainers that pass through European Medicines Agency
European Medicines Agency is a step on the way to someone elseAround European Medicines Agency this week
News at the entities that move European Medicines Agency most-
Novo Nordisk StructuralBerenberg Bank reissued a neutral rating on Novo Nordisk shares today.Moves European Medicines Agency
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FDA OperationalNeurogene Inc. developed a gene therapy for Rett syndrome and received FDA agreement for a registrational trial design.Moves European Medicines Agency
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OCS StructuralCannabis products were listed with OCS and delivered to BC Cannabis Stores, with product reloading occurring in Saskatchewan.Moves European Medicines Agency
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India StructuralReport tracks the mobility credit market in India, noting that NBFCs are leading vehicle financing.Moves European Medicines Agency
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AbbVie StructuralAbbVie reached an agreement for a drug in Canada.Moves European Medicines Agency
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Eli Lilly and Company StructuralMedicare coverage is driving growth in the obesity drug market, leading to raised price targets for Eli Lilly.Moves European Medicines Agency
Connections
The 40 strongest of 119, analyzed from the reporting. The bars show how strongly a change on one side reaches the other.-
Novo Nordisk Structural
Novo Nordisk relies on the EMA for market authorization and evaluation of its products.
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European Commission Structural
EMA provides scientific opinions and recommendations that the European Commission reviews and uses to issue final market authorization decisions.
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FDA Operational
The FDA and EMA actively coordinate on regulatory standards, jointly evaluate drug applications, and share global leadership in drug approval processes.
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Eli Lilly and Company Structural
The EMA's regulatory recommendations and approvals directly determine Eli Lilly's market access and financial performance in Europe.
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Cosm Structural
The European Medicines Agency formally regulates and certifies Cosm's manufacturing operations under EU GMP standards.
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Fresenius Kabi Transactional
EMA accepted the Marketing Authorization Application (MAA) for the vedolizumab biosimilar product associated with Fresenius Kabi.
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AbbVie Structural
The European Medicines Agency reviews and grants market approval for AbbVie's pharmaceutical products in Europe.
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Valneva SE Structural
The EMA formally validated the Marketing Authorization Application for a vaccine developed by Valneva SE.
Show all 40 connections
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Pfizer Transactional
EMA formally validated Pfizer's vaccine application, initiating the assessment process.
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company Structural
The company's operation and facilities are formally regulated and certified by the European Medicines Agency.
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government Structural
The EMA calls upon the government to establish an emergency task force to manage the current situation.
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AstraZeneca Structural
The European Medicines Agency reviews AstraZeneca's products for market approval.
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OCS Structural
OCS is undergoing the formal regulatory review process with the European Medicines Agency, culminating in the PRIME designation for its product.
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Omeros Corporation Structural
EMA formally reviewed Omeros's marketing authorization application and issued a negative opinion.
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WuXi Biologics Structural
The European Medicines Agency regulates WuXi Biologics through facility inspections and enforcement of GMP standards.
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Novartis Transactional
The EMA issued a positive regulatory opinion regarding a specific drug developed by Novartis.
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Chiesi Structural
Chiesi seeks validation for its products from the European Medicines Agency for market access in Europe.
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Acadia Pharmaceuticals Structural
The EMA formally reviews Acadia's drug applications for European market access and approval.
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Zambon Structural
The European Medicines Agency issued a positive regulatory opinion on a product associated with Zambon.
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Hansa Biopharma Structural
Hansa Biopharma relies on the European Medicines Agency for the review and market approval of its drug candidates.
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India Structural
India's pharmaceutical companies seek approval from the European Medicines Agency for market access.
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Emer Cooke Structural
Emer Cooke serves as the executive director for the European Medicines Agency.
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GSK Structural
The European Medicines Agency evaluates GSK's product submissions as part of the market authorization process in the EU.
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HCC Structural
The EMA provides pivotal guidance and evaluation for HCC's product program, establishing a regulatory dependency.
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Alvotech Structural
Alvotech submits regulatory applications to the European Medicines Agency for product approval.
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Biocon Structural
The European Medicines Agency is reviewing Biocon's biosimilar application for market access in Europe.
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Greece Structural
one depends on the other
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HSE Structural
EMA's regulatory approval is a necessary condition for the use of drugs within the HSE service provision structure.
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GeoVax Structural
EMA granted GeoVax an expedited pathway for clinical trials, establishing a regulatory dependency.
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sobi Structural
EMA provides regulatory approval for Sobi's pharmaceutical products.
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Creon Transactional
The EMA is evaluating Creon, noting production limitations and high market demand.
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Crinetics Pharmaceuticals Structural
EMA regulates Crinetics Pharmaceuticals, requiring product approval for market entry.
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Merck Operational
Merck received acceptance from the European Medicines Agency to expand its marketing authorization.
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Avantor Structural
Avantor's products are subject to regulatory review by the European Medicines Agency.
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Hyderabad Structural
Facilities in Hyderabad operate under the regulatory standards and certification requirements set by the European Medicines Agency.
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Incyte Structural
Incyte relies on the European Medicines Agency for regulatory approval of its pharmaceutical products.
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Aurobindo Pharma Structural
The European Medicines Agency has certified a facility belonging to Aurobindo Pharma.
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Spain Structural
The European Medicines Agency sets regulatory standards that apply to Spain as an EU member state.
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Japan Operational
The relationship is characterized by the EMA's function in medicine, which is relevant to the Japanese market.
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Indian Pharmacopoeia Commission Shared context
The two bodies operate within the shared global framework of international drug regulation and pharmacovigilance.
History
Events by the month they beganOctober 2026
8 events- Glenn attended a congress in Amsterdam and participated in a panel with an official from the European Medicines Agency.
- Both the FDA and European Medicines Agency must adopt evidence-based principles for drug regulation.
- Ascendis Pharma A/S received FDA approval and is moving forward with its first EU launch in Germany.
- EMA adopted a positive opinion for Sobi's drug, with the European Commission set to confirm the decision.
- Alvotech submitted a regulatory application to the European Medicines Agency (EMA).
- PolyPid Ltd's product received FDA Priority Review and gained single authorization across EU states from the EMA.
- Aemps was identified as Spain's national medicines watchdog.
- Aedes mosquitoes are spreading Chikungunya virus, leading to regulatory actions and vaccine trials involving Valneva and the EMA.
September 2026
15 events- Both the FDA and the European Medicines Agency are evaluating NervGen's lead therapeutic candidate.
- Emer Cooke has been named the executive director at the European Medicines Agency (EMA).
- Regulatory bodies, including the EMA and FDA, are reviewing evidence regarding semaglutide and its possible association with NAION, a serious eye stroke.
- WuXi Biologics received EMA approval and successfully passed FDA GMP inspection.
- A company plans to submit regulatory applications to the FDA, EMA, and Australian TGA.
- The European Medicines Agency provided a positive opinion on a drug developed by Novartis.
- The FDA and European Medicines Agency discussed sharing the global regulatory leadership mantle.
- The European Medicines Agency is seeking a positive opinion regarding the market access for a Pertuzumab biosimilar.
- Citigroup involved in global financial markets; India and Canada aiming to close CEPA trade pact; Biocon arm seeks EMA CHMP approval for drug.
- Innate Pharma S.A. is seeking market access for its drug lacutamab in Europe, successfully achieving Breakthrough and Fast Track designations. Sobi holds the exclusive global commercialization rights.
- Oncopeptides AB's drug received a positive opinion from the EMA, leading to the European Commission making a final decision for the EU market.
- Novo Nordisk is seeking marketing authorization from the European Medicines Agency (EMA).
- The FDA and European Medicines Agency are harmonizing regulatory review of drug applications.
- OS Therapies, Inc. is seeking regulatory approval from the European Medicines Agency for a new cancer treatment.
- Seeking validation for next-gen pMDIs in Europe.
August 2026
15 events- Both the FDA and the European Medicines Agency govern drug approval processes.
- IGC Pharma, Inc. is preparing data for potential U.S. FDA review and seeking EMA support for its lead drug candidate.
- The EMA has validated the Marketing Authorization Application (MAA) for a vaccine developed in collaboration between Valneva and Pfizer.
- Ascletis Pharma expects to submit its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in early 2029.
- AbbVie submitted an application for the Skyrizi induction regimen to the European Medicines Agency.
- EMA adopted a positive opinion and the European Commission granted marketing authorization for the drug Hopledo.
- AbbVie submitted an application for risankizumab approval to the European Medicines Agency.
- INmune Bio Inc. submitted an Orphan Drug Designation and Scientific Advice package to the European Medicines Agency.
- EMA validated marketing authorization and FDA accepted NDA for Pharvaris N.V.'s lead drug.
- EMA approved a drug for patient use, prompting the National Centre for Pharmacoeconomics to demand price reduction and TDs to urge reimbursement.
- The European Medicines Agency is regulating market applications for pharmaceuticals while market sentiment is affected by the ongoing conflict and uncertainty in the Middle East, specifically regarding Hormuz.
- Both the FDA and the European Medicines Agency are reviewing deucrictibant for approval.
- Retatrutide lacks marketing authorization in the EU and is being used as an underground marketplace for unregulated drugs.
- The European Medicines Agency adopted a negative opinion on Zevra Therapeutics' MAA, while Pomerantz LLP simultaneously investigated securities fraud claims.
- A company is progressing its regulatory filings, utilizing a facility in Stevenage, England, with the UK filing preceding the EMA application in 2027.
Show 2 earlier months
July 2026
12 events- Hansa Biopharma is seeking approval for its drug Idefirix in various markets, with SERB handling commercialization in EU member states.
- Fresenius Kabi received regulatory approvals from the EMA and FDA for a vedolizumab biosimilar, while excluding commercialization in the Middle East and North Africa.
- IMPACT Therapeutics and Pharmanovia entered an exclusive partnership for the drug senaparib, granting rights in all 27 EU member states and Australia/New Zealand.
- Avantor and the Population Council expanded collaboration on an HIV prevention ring project, moving the product into regulatory review.
- Menarini Group and NewAmsterdam Pharma Company N.V. are collaborating on drug development, seeking marketing authorization in Europe through the EMA and EC process.
- The European Medicines Agency and European Commission are jointly developing Enhertu for market approval and seeking authorization in the EU.
- A facility received EMA certification alongside ANVISA approval for market access.
- The European Medicines Agency (EMA) is evaluating experimental treatments that were developed in Japan.
- The European Medicines Agency reviews submissions for pharmaceutical products.
- Hospitals in India, Israel, and the Netherlands are currently experimenting with dose reduction protocols for clinical trials under the purview of the FDA and the European Medicines Agency.
- OCS is seeking Priority Medicines and Breakthrough Therapy designations for Privosegtor for optic neuritis from the FDA and EMA.
- The European Medicines Agency approved a drug change related to a Lupin facility in New Jersey, while market movements saw Infosys and Bajaj Finance fluctuate, and Thermax was listed among capital goods losers.
June 2026
10 events- Omeros Corporation's drug received FDA approval and is currently undergoing review by the European Medicines Agency.
- Reports indicate Europe-wide drug shortages are occurring due to production limitations and high demand, monitored by the European Medicines Agency.
- The FDA and European Medicines Agency engaged in joint coordination regarding regulatory dossier evaluation.
- The European Medicines Agency (EMA) has made a decision regarding the case-by-case use of a medicine.
- Hansa Biopharma submitted an application for full marketing authorization to the European Medicines Agency.
- Trump-era tariffs benefit undervalued AI stocks, while AbbVie acquires Apogee Therapeutics, and regulatory applications for cemdisiran are reviewed by EMA.
- Oil prices eased after the Strait of Hormuz closure, while the European Medicines Agency recommended medicines for Eli Lilly.
- Cosmos Health is establishing manufacturing licenses under European Good Manufacturing Practices and securing distribution agreements for international expansion.
- The European Medicines Agency is seeking a positive opinion on ruxolitinib cream, with final approval resting with the executive branch.
- Acadia Pharmaceuticals received final market authorization in the EU for its drug DAYBU after receiving a positive opinion from the European Medicines Agency.