Healio

FDA again rejects tabelecleucel for EBV-driven post-transplant lymphoproliferative disease

The FDA has issued a second complete response letter to Atara Biotherapeutics for its biologicals license application of ...
JD Supra

FDA Accepts U.S. Biologics License Application for AVT06, Alvotech and Teva’s Proposed Aflibercept Biosimilar

On February 18, 2025, Alvotech and Teva Pharmaceuticals (“Teva”) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, a ...
JD Supra

FDA Issues a Final Rule on Biologics License Applications, Investigational New Drug Applications and Master Files

On February 12, the FDA issued a final rule regarding the use of Drug Master Files (“DMF”) in Biologics License Applications. DMFs are submissions to the FDA “used to provide confidential, detailed ...
MPR

Valneva Withdraws Chikungunya Vaccine BLA After FDA Suspension

Valneva withdrew its chikungunya vaccine applications following a license suspension and data suggesting a probable link to serious adverse outcomes.
STAT

FDA pulls biologics license for chikungunya vaccine

Meghana Keshavan covers biotech and contributes to The Readout newsletter. Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.
Healio

FDA postpones review of bimekizumab biologics license application

Please provide your email address to receive an email when new articles are posted on . The FDA review of bimekizumab’s biologics license application was expected in the second quarter of 2023. UCB ...
Nasdaq

Capricor Therapeutics Announces Successful FDA Pre-License Inspection and Upcoming Advisory Committee Meeting for Deramiocel in Duchenne Muscular Dystrophy Treatment

Capricor Therapeutics announced that it has successfully completed the U.S. FDA's Pre-License Inspection of its San Diego manufacturing facility for its lead therapy candidate, Deramiocel, aimed at ...
Business Wire

FDA Accepts Biologics License Applications for exagamglogene autotemcel (exa-cel) for Severe Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia

BOSTON & ZUG, Switzerland--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and CRISPR Therapeutics (Nasdaq: CRSP) today announced that the U.S. Food and Drug Administration (FDA) ...
E&E

FDA pulls license for chikungunya shot as safety reports mount

The Food and Drug Administration has suspended the license for Valneva’s chikungunya vaccine Ixchiq amid safety concerns, the French manufacturer said Monday. Valneva said in a statement that the ...