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.
- A company is seeking FDA 510(k) clearance while simultaneously conducting a private placement and qualifying its prospectus in British Columbia.
- FDA confirmed CMC and device plans are Phase 3 ready, coinciding with strengthening of US and EU patent estates.
- The FDA granted 510(k) clearance to SimBioSys's software.
- New FDA rule threatens the ability to import medicines.
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.