Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activity M ...

French drug major Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that the U.S. Food and Drug Administration ...

Mesoblast Limited (AU:MSB) has released an update. Mesoblast Limited is making strides in the development and potential commercialization of ...

HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on ...

As of September 30, 2024, Fortress' consolidated cash and cash equivalents totaled $58.9 million, compared to $76.2 million ...

Shares of Omeros touched a 52-week high, a day after the company said it could resubmit its biologics license application for narsoplimab to the Food and Drug Administration. In Thursday afternoon ...

Adaptimmune’s Phase II IGNYTE-ESO trial investigating experimental T cell therapy lete-cel has achieved its primary endpoint.

The approval marks the first time gene therapy will be available to treat patients with aromatic I-amino acid decarboxylase ...

Participants were broken into two cohorts. The first cohort received one of three doses of PCRX-201. The second cohort received concurrent pretreatment with an intraarticular corticosteroid ...

The US Food and Drug Administration (FDA) has granted accelerated approval for PTC Therapeutics’ KEBILIDI, the first gene ...

FDA accepts BLA resubmission of pz-cel in recessive dystrophic epidermolysis bullosa and sets PDUFA target action date of April 29, 2025 Company makes significant progress toward potential commerciali ...

Following strong treatment response data for Adaptimmune’s lete-cel, the biotech is planning to initiate a rolling BLA ...