FDA reached an agreement on CMC data requirements for Savara, while Fujifilm Diosynth Biotechnologies announced a change in drug substance manufacturer.
1 report, 1 independent
Updated Aug 23
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What happened
FDA reached an agreement on CMC data requirements for Savara, while Fujifilm Diosynth Biotechnologies announced a change in drug substance manufacturer.
Who's involved
What this event is mainly aboutKeep exploring
The entities involved
- FDA
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Savara (Denmark)
company in Hørsholm, Denmark
Nothing else this week.
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Fujifilm Diosynth Biotechnologies
biotech contract development and manufacturing organization
Nothing else this week.
Related events
- The FDA requested additional clinical data from Unicycive Therapeutics.
- FDA raised concerns over cell therapy evidence for Capricor Therapeutics, causing a sharp drop in stock price.
- Biocon's subsidiary received FDA approval for a drug in the United States on August 18, 2026.
- The FDA recommended advancement for a new drug application submitted by a company.
- The FDA is monitoring drug industry practices and pricing, utilizing studies published by JAMA.
Coverage
Newest first; wire copies grouped- Insider MonkeySavara Inc. (SVRA) Upgraded to Buy After FDA CMC Breakthrough Savara Inc. (NASDAQ:SVRA) is among the best US stocks under $10 to invest in. H.C. Wainwright has raised the price target on Savara Inc.