WY Biotech is now obligated to pay a $7 million upfront license fee to HCW Biologics by Sept. 30, according to a filing with the Securities and Exchange Commission. HCW Biologics previously said it ...

Shares of Regeneron Pharmaceuticals, Inc. REGN have lost 22.6% year to date against the industry’s growth of 0.6%. The stock ...

The FDA has accepted for review the sBLA to expand the indication of Arexvy (RSV vaccine, adjuvanted) to adults aged 18 to 49 years who are at increased risk.

George Mulligan, PhD, previews the FDA's ODAC meeting discussing the application of belantamab mafodotin-based combinations for the treatment of multiple myeloma.

The U.S. FDA has accepted a Biologics License Application (BLA) for BAT2506, a proposed biosimilar to Simponi (golimumab).

Ultragenyx Pharmaceuticals RARE announced that the FDA has issued a Complete Response Letter (CRL) for its biologics license ...

Nanoscope Therapeutics submitted the first modules of a biologics license application for MCO-010, an investigational gene ...

The FDA has accepted for priority review a new supplemental biologics license application for Winrevair to treat adults with ...

RGX-121 is a potential one-time AAV therapeutic for the treatment of boys with MPS II, designed to deliver the iduronate-2-sulfatase (IDS) gene to the central nervous system (CNS). Delivery of the ...

RGX-121 is a potential one-time AAV therapeutic for the treatment of boys with MPS II, designed to deliver the iduronate-2-sulfatase (IDS) gene to the central nervous system (CNS). Delivery of the ...

FDA Accepts Biologics License Application for Mucopolysaccharidosis II Treatment Provided by PR Newswire May 14, 2025, 4:13:00 AM ...

FDA Accepts Biologics License Application for Mucopolysaccharidosis II Treatment By NS Pharma, Inc. 28 mins ago Logo for NS Pharma, Inc. (PRNewsfoto/NS Pharma, Inc.) By NS Pharma, Inc.