The FDA accepted a revised approval submission regarding a Biohaven drug, while simultaneously canceling advisory committee discussions. This occurred amidst corporate restructuring, including Novo Holdings acquiring Catalent, which has a gene therapy facility in Baltimore.
1 report, 1 independent
Updated Aug 22
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What happened
The FDA accepted a revised approval submission regarding a Biohaven drug, while simultaneously canceling advisory committee discussions. This occurred amidst corporate restructuring, including Novo Holdings acquiring Catalent, which has a gene therapy facility in Baltimore.
Who's involved
What this event is mainly aboutKeep exploring
The entities involved
- FDA
-
Stealth BioTherapeutics (United States)
company in Newton, United States
Nothing else this week.
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Catalent (United Kingdom)
company in Swindon, United Kingdom
Nothing else this week.
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Novo Holdings
Danish company
Nothing else this week.
Related events
- The FDA indicated on June 25, 2025, that an Advisory Committee (AdCom) was not necessary for a specific review.
- BioXcel Therapeutics received FDA approval for its drug and announced results from New Haven.
- FDA placed a clinical hold on a gene therapy involving Hunter.
- Biocon's subsidiary received FDA approval for a drug in the United States on August 18, 2026.
- Cardiol Therapeutics Inc. is listed on Nasdaq and is developing therapy for an FDA-approved indication.
Coverage
Newest first; wire copies grouped- BioPharma DiveFDA cancels adcomm on Biohaven drug; Catalent lays off staff This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive news