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The Pharma Letter9h
FDA refuses to file Savara BLA for Molbreevi
Texas, USA-based clinical-stage biopharma Savara (Nasdaq: SVRA) on Tuesday announced that the company received a refuse to ...
Healio1d
FDA grants rare pediatric disease designation for Stargardt disease gene therapy
The FDA granted rare pediatric disease designation for OCU410ST, a gene therapy designed to treat ABCA4-associated ...
JD Supra1d
FDA Approves BLA for Novavax’s COVID-19 Vaccine
Novavax, Inc. (“Novavax”) announced that FDA approved its Biologics License Application (“BLA”) for Nuvaxovid™ for active ...
Savara Shares Slide After FDA Declines Drug Application
Savara plans to request a Type A meeting with the FDA within the next 30 days. It is currently generating the data requested by the FDA, and expects to resubmit its application in the fourth quarter ...
Savara to meet FDA as marketing application is found to be incomplete
Savara (SVRA) stock in focus as FDA issues a refusal to file letter regarding its marketing application for its lead drug, ...
Pharmaceutical Technology on MSN1d
FDA to review Otsuka’s sibeprenlimab application for IgAN
The US Food and Drug Administration (FDA) has accepted Otsuka Pharmaceutical’s biologics licence application for ...
Moderna, Inc. (MRNA) Withdraws Application for COVID-flu Combination Vaccine
Moderna, Inc. (NASDAQ:MRNA) made a name for itself by quickly developing an effective coronavirus vaccine when the world ...