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 ...

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 ...

Denali Therapeutics, Inc. DNLI announced that the FDA has accepted for review its biologics license application (BLA) for ...

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.

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 ...

AbbVie Submits Biologics License Application to U.S. FDA for TrenibotulinumtoxinE (TrenibotE) for the Treatment of Glabellar Lines PR Newswire NORTH CHICAGO, Ill., April 24, 2025 ...