Entities / Entity
United States Food and Drug Administration.
agency of the US Department of Health and Human Services
- Reports this week
- 5
- Active events
- 3
- Connections
- 571
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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FDA gave tentative approval to Lupin for an alternative formulation of a Bristol-Myers Squibb drug, which Lupin plans to manufacture in Somerset.Some support1 report
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FDA inspection at Unichem Laboratories Limited's Goa facility found procedural enhancements needed, leading to market reaction.Some support2 reports
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AbbVie and Cerevel Therapeutics successfully launched a new drug for Parkinson's disease, pending government coverage negotiations.Some support3 reports
Earlier this month
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Routine cGMP inspection found three observations at a Strides Pharma Science Limited manufacturing facility in Chennai.Some support1 report
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Food safety bills introduced in Virginia regarding FDA code updates and state protocols.Some support1 report
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USFDA confirmed compliance for Alembic Pharmaceuticals' bioequivalence facility located in Vadodara, Gujarat.Some support2 reports
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A routine inspection of a GMP manufacturing unit in Visakhapatnam, Andhra Pradesh, was conducted by the United States Food and Drug Administration and confirmed regulatory compliance.Some support1 report
One to three months ago
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The US Food and Drug Administration conducted a cGMP inspection at a facility belonging to Cipla.Some support2 reports
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The US Food and Drug Administration conducted a routine cGMP inspection of a facility belonging to OneSource Specialty Pharma Limited.Some support1 report1 development inside
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USFDA conducted an inspection of Strides Pharma Science Limited's flagship manufacturing facility in Bengaluru, India.Some support1 report
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U.S. FDA granted final approval for Pitolisant Tablets, confirming its bioequivalence to Wakix®.Some support1 report
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The US Food and Drug Administration inspected a plant located in Raleigh, North Carolina.Some support1 report
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Vicore Pharma Holding AB listed its shares on Nasdaq and received drug designation from the United States Food and Drug Administration.Some support2 reports
Gone quiet
No new reports in 90+ days-
An inspection regarding API manufacturing standards was conducted at a facility in Srikakulam district, involving Aurobindo Pharma and Auroactive Pharma.Some support1 report
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The FDA has granted tentative approval for Lupin's drug application, noting its bioequivalence to Astellas' reference drug.Some support1 report
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The US Food and Drug Administration conducted an inspection in Anakapalli district, which is located in the state of Andhra Pradesh.Some support1 report
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The United States Food and Drug Administration inspected a Formulation facility in Sangareddy District, resulting in OAI status.Some support2 reports
No events began in the chosen period. Widen it, or reset.
Around United States Food and Drug Administration this week
News at the entities that move United States Food and Drug Administration most-
Virginia StructuralA van incident occurred in Rosslyn, Virginia, involving State Senator Barbara Favola.Moves United States Food and Drug Administration
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Mesoblast StructuralTrump pledged to unleash American oil and gas production.Moves United States Food and Drug Administration
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Aurobindo Pharma StructuralMSD and Aurobindo Pharma signed a voluntary licensing agreement for generic alimatravir.Moves United States Food and Drug Administration
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AbbVie StructuralA fund holding diverse stocks, including Canadian dividend stocks, was mentioned as part of its strategy.Moves United States Food and Drug Administration
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North Carolina StructuralMatthew Rutter attended a convention held in North Carolina on June 19, 2026.Moves United States Food and Drug Administration
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Telangana Shared contextCounterfeit vaccine manufactured in Telangana was seized in Delhi.Moves United States Food and Drug Administration
Connections
The 12 strongest of 571, analyzed from the reporting. The bars show how strongly a change on one side reaches the other.-
Cipla Structural
USFDA conducts cGMP inspections at Cipla facilities as part of regulatory oversight.
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Virginia Structural
FDA food code updates establish standards that influence and govern state-level operational protocols in Virginia.
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Wockhardt Structural
Wockhardt achieved NCE approval from the United States Food and Drug Administration.
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Mesoblast Structural
The US FDA formally granted RMAT designation to Mesoblast, establishing a regulatory oversight relationship.
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GMP Structural
The FDA exercises mandatory oversight over GMP, requiring routine inspections to ensure regulatory compliance.
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Formulation Structural
Formulation is subject to inspection and regulatory oversight by the USFDA, which determines operational status.
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Aurobindo Pharma Structural
US FDA conducts inspections of Aurobindo Pharma subsidiaries as part of regulatory oversight.
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AbbVie Structural
AbbVie's ability to market drugs depends on formal regulatory approval from the United States Food and Drug Administration.
Show all 12 connections
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Srikakulam Shared context
The US FDA conducted an inspection of a subsidiary located in Srikakulam.
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North Carolina Structural
The USFDA conducts regulatory inspections within North Carolina's jurisdiction.
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Telangana Shared context
The USFDA conducts regulatory inspections within the geographical context of Telangana.
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Anakapalli district Shared context
The US FDA performed an inspection while operating within the Anakapalli district.
History
Events by the month they beganSeptember 2026
7 events- FDA gave tentative approval to Lupin for an alternative formulation of a Bristol-Myers Squibb drug, which Lupin plans to manufacture in Somerset.
- FDA inspection at Unichem Laboratories Limited's Goa facility found procedural enhancements needed, leading to market reaction.
- AbbVie and Cerevel Therapeutics successfully launched a new drug for Parkinson's disease, pending government coverage negotiations.
- Routine cGMP inspection found three observations at a Strides Pharma Science Limited manufacturing facility in Chennai.
- Food safety bills introduced in Virginia regarding FDA code updates and state protocols.
- USFDA confirmed compliance for Alembic Pharmaceuticals' bioequivalence facility located in Vadodara, Gujarat.
- A routine inspection of a GMP manufacturing unit in Visakhapatnam, Andhra Pradesh, was conducted by the United States Food and Drug Administration and confirmed regulatory compliance.
August 2026
4 events- The US Food and Drug Administration conducted a cGMP inspection at a facility belonging to Cipla.
- USFDA conducted an inspection of Strides Pharma Science Limited's flagship manufacturing facility in Bengaluru, India.
- U.S. FDA granted final approval for Pitolisant Tablets, confirming its bioequivalence to Wakix®.
- The US Food and Drug Administration inspected a plant located in Raleigh, North Carolina.
July 2026
2 eventsShow 1 earlier month
June 2026
4 events- An inspection regarding API manufacturing standards was conducted at a facility in Srikakulam district, involving Aurobindo Pharma and Auroactive Pharma.
- The FDA has granted tentative approval for Lupin's drug application, noting its bioequivalence to Astellas' reference drug.
- The US Food and Drug Administration conducted an inspection in Anakapalli district, which is located in the state of Andhra Pradesh.
- The United States Food and Drug Administration inspected a Formulation facility in Sangareddy District, resulting in OAI status.