A decision on the resubmitted application is expected within 60 days of the FDA’s receipt of it, the company said.
Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) for the treatment of ...
Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, announced today that the U.S. Food and Drug Administration ...
Linvoseltamab's BLA resubmission is under FDA review, with a decision anticipated by July 2025, supported by LINKER-MM1 trial data. The trial evaluates linvoseltamab's safety, tolerability, and ...
Scholar Rock outlines 2026 apitegromab BLA resubmission and commercial launch following FDA progress
CEO David Hallal stated that "Scholar Rock is poised for a transformative year in 2026," emphasizing the company's focus on delivering the world's first muscle-targeted therapy to children and adults ...
(RTTNews) - Iterum Therapeutics (ITRM) announced the FDA has acknowledged receipt of the resubmission of the New Drug Application for sulopenem etzadroxil/probenecid for the treatment of uncomplicated ...
Pharmaceutical Technology on MSN
FDA issues complete response letter to Sobi’s NASP for gout
The FDA did not identify concerns about the clinical efficacy or safety of NASP that would affect its potential for approval.
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