The suspension of the license requires Valneva to immediately stop shipping and selling Ixchiq in the US. The Food and Drug Administration (FDA)’s Center for Biologics Evaluation and Research (CBER) ...

Please provide your email address to receive an email when new articles are posted on . Phase 3 ZENITH trial data assessing Winrevair in adults with WHO functional class III or IV PAH support the new ...

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 ...

An Instagram ad catches your eye. You click to the product’s website and find reassurance: The product, it says, is "FDA certified" or was "produced in an FDA registered facility." Mention of the U.S.

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.

In the fifth part of our FDA: Drug & Device Team’s series on biological products regulation, we discuss key considerations for biologics license applications (BLAs) and the Food and Drug ...

PARAMUS, N.J., March 10, 2025 /PRNewswire/ -- NS Pharma, Inc. (NS Pharma), a subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku), announced today that ...

WOBURN, Mass., July 22, 2025 (GLOBE NEWSWIRE) -- Replimune Group (REPL), Inc. , a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced ...

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 ...