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Pharmaceutical Technology on MSN
Atara receives FDA complete response letter for Ebvallo BLA application
The BLA was resubmitted in 2025, after Atara and the FDA aligned on the criteria and addressed the initial CRL conditions.
Replimune Announces FDA Acceptance of BLA Resubmission of RP1 for the Treatment of Advanced Melanoma
WOBURN, Mass., Oct. 20, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced ...
A new Prescription Drug User Fee Act target date of February 8, 2026 has been set for the application. The Food and Drug Administration (FDA) has extended the review for the Biologics License ...
Valneva has made the decision to withdraw the Biologics License Application for its chikungunya vaccine Ixchiq®.
CEO Matthew Kapusta reported, "in the third quarter, we announced positive top line data from our pivotal Phase I/II study of AMT-130 in Huntington's disease, the first gene therapy to demonstrate ...
Capricor plans to resubmit its BLA to the FDA, incorporating data from the ongoing Phase 3 HOPE-3 trial, indicating proactive steps toward potential approval for Deramiocel. The FDA's invitation for ...
PLYMOUTH MEETING, Pa., Dec. 29, 2025 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from ...
SAN DIEGO, Oct. 13, 2025 /PRNewswire/ -- Avidity Biosciences, Inc. (RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates ...
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