BASKING RIDGE, N.J. & RAHWAY, N.J.--(BUSINESS WIRE)-- The Biologics License Application (BLA) seeking accelerated approval in the U.S. for Daiichi Sankyo (TSE: 4568) and Merck’s (NYSE ...

The FDA biologics license application for patritumab deruxtecan in EGFR+ NSCLC has been withdrawn following discussions with ...

(RTTNews) - The Biologics License Application (BLA) seeking accelerated approval of patritumab deruxtecan, co-developed by Merck & Co Inc. (MRK) and Daiichi Sankyo Company, Limited (DSKYF ...

Immatics (NASDAQ:IMTX) shares surged 11.7% after early trial results of IMA203 cell therapy showed a 56% response rate in ...

The US Food and Drug Administration (FDA) has accepted Otsuka Pharmaceutical’s biologics licence application for ...

Moderna, Inc. (NASDAQ:MRNA) today announced that it had voluntarily withdrawn the pending Biologics License Application (BLA) ...

announced today that the U.S. Food and Drug Administration has accepted for review the Biologics License Application (BLA) submission by REGENXBIO Inc. (REGENXBIO; Headquarters: Rockville ...

Moderna has withdrawn the BLA for mRNA-1083, a combination vaccine against seasonal influenza and SARS-CoV-2, after consulting with FDA.

PARAMUS, N.J., May 14, 2025 /PRNewswire/ -- NS Pharma, Inc. (NS Pharma), a subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku) announced today that the U.S. Food and Drug Administration has ...

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 ...

Simris Group AB (publ), through its wholly owned subsidiary Simris Biologics GmbH, has signed a non-binding concept sheet with a EU based biopharmaceutical company specializing in the development of ...

Savara Receives Refusal to File (RTF) Letter From the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for MOLBREEVI* to Treat Patients With Autoimmune Pulmonary ...