DBV Technologies S.A. Châtillon, France, March 24, 2025 DBV Technologies Secures Agreement with FDA on Safety Exposure Data Required for Biologics License Application (BLA) for Viaskin® Peanut ...

Quetta: The Baloch Liberation Army (BLA) freedom fighters on Saturday claimed that they have taken complete control of Surab city in the Balochistan province of Pakistan, paralysing all military ...

The Baloch Liberation Army (BLA) has taken complete control of Surab city of Pakistan, news agency ANI has reported. The BLA, as part of a large-scale armed operation, has also targeted state ...

Findings from HERTHENA-Lung02 showed that the key secondary endpoint of overall survival did not meet statistical significance. Daiichi Sankyo and Merck have voluntarily withdrawn the Biologics ...

The companies said that their decision to pull the Biologics License Application (BLA) follows a topline readout from a Phase 3 trial for HER3-DXd and discussions with the FDA. It was not related ...

The Company plans to resubmit the BLA later this year, after vaccine efficacy data from the ongoing Phase 3 trial of its investigational seasonal influenza vaccine, mRNA-1010, are available.

FDA Accepts Resubmission of BLA for Narsoplimab for Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy (TA-TMA) and Assigns Late September PDUFA Date Omeros Corporation ...

On May 19, Novavax, Inc. (“Novavax”) announced that FDA approved its Biologics License Application (“BLA”) for Nuvaxovid™ for active immunization against COVID-19 in adults 65 years and ...

Patritumab deruxtecan's BLA withdrawal was due to HERTHENA-Lung02 trial's unsatisfactory overall survival results, despite progression-free survival significance. The HERTHENA-Lung02 trial compared ...

Omeros Corporation (Nasdaq: OMER) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for ...