Authorization Application News Today

Longer follow up and subset analyses from the pivotal FELIX Phase 2 data to be presented in oral presentations at ASCO and EHATwo patients enrolled in Phase 1 Systemic Lupus Erythematosus trial;...

/PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced the U.S. Food and Drug Administration (FDA) has accepted the companys...

Total of 20 Centers Currently Open with Approximately 40 Expected by End of 2023 in SHIELD II Phase 3 Trial Evaluating D-PLEX100 for the Preventio...

Jena, Germany, November 1, 2023 - InflaRx N.V. , a biotechnology company pioneering anti-inflammatory therapeutics targeting the complement system, announced today financial results...

Single ascending dose (SAD) Phase I data confirm best-in-class potential of orally available C5aR inhibitor INF904; multiple ascending dose (MAD) ...

TOKYO, Aug. 18, 2023 /PRNewswire/ -- Astellas Pharma Inc. , today announced the European Medicines Agency has accepted for regulatory review the marketing authorization application for...

Regulatory progress for govorestat for the treatment of Classic Galactosemia, with potential NDA submission based on discussions with the FDA as well as EMA Marketing Authorization Application... -Today at 07:04 am- MarketScreener

Pre-NDA Meeting to be held with FDA this summer to discuss potential NDA submission for govorestat for treatment of Classic Galactosemia EMA Marketing Authorization Application for govorestat for...

STOCKHOLM, June 8, 2023 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that Eisai has submitted a marketing authorization application for lecanemab

/PRNewswire/ -- BioArctic ABs (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that Eisai has submitted a marketing authorization application...