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 ...

Shares of Capricor Therapeutics CAPR tanked 33% on Friday after it announced that the FDA issued a complete response letter ( ...

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

Mesoblast’s RYONCIL ® (remestemcel-L) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA approved mesenchymal ...

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.

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 ...