The FDA has updated guidance outlining how it applies regulatory flexibility to chemistry, manufacturing and control requirements for cell and gene therapies. The agency said the approach is meant to ...
GlobalData on MSN
FDA increases manufacturing flexibility for cell and gene therapies
Clinical and commercial quality controls are eased as the FDA looks to expedite therapy approvals in areas of unmet need.
After greenlighting 56 novel therapeutics in 2025, four notable applications continue to await the agency’s action after ...
Atara Biotherapeutics received a second complete response letter from the FDA for its biologics license application for ...
Yield-Enhanced Production Execution. Yield-enhanced production moved into routine commercial execution during 2025, with ...
FDA assigned PDUFA target action date of July 7, 2026.If approved, atacicept would be the first B cell modulator targeting ...
Stocktwits on MSN
MLTX stock extends rally as FDA feedback spurs bullish brokerage action – retail speculates on potential M&A conversations
H.C. Wainwright raised MoonLake’s price target to $32 from $26 and maintained a ‘Buy’ rating. ・BTIG said the FDA approval ...
ScinoPharm receives US FDA approval for glatiramer acetate injection to treat multiple sclerosis: Taiwan Tuesday, January 6, 2026, 14:00 Hrs [IST] ScinoPharm Taiwan, a professiona ...
Vera Therapeutics stock rose on FDA acceptance of atacicept BLA for priority review in IgAN, a potential multi-billion dollar ...
MoonLake regains momentum after the FDA Type B meeting allows BLA submission for sonelokimab in HS without additional trials.
SaveHealth reports on common rheumatoid arthritis medications, highlighting their effectiveness, side effects, and cost ...
Moving Biotech (4MB), a clinical stage biotechnology company developing next-generation, disease-modifying therapies for ...
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