The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults and pediatric ...

HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing ...

Emrosi approved by FDA on November 4 for the treatment of inflammatory lesions of rosacea in adults Cosibelimab PDUFA goal date of December 28 for potential approval to treat metastatic or locally adv ...

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

Wong, Founder and CEO of HCW Biologics, stated, “In the third quarter 2024, the Company expanded our product portfolio and possible disease indications that may be treated with our immunotherapeutic ...

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.

1. About lecanemab (generic name, brand name: Leqembi®) Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal ...

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

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

As described in previous updates, we have been working closely with FDA regarding the anticipated resubmission of our Biologics License Application, or BLA for narsoplimab in hematopoietic stem cell ...

following the approval of ATSN-101’s Biologics License Application (BLA), the company will retain all rights, title, and ...