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

Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and ...

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 ...

What Should Capricor Therapeutics, Inc. Investors Do? If you invested in Capricor Therapeutics, Inc., visit our Capricor Terapeutics, Inc. Investigation webpage or call us at (888) 410-2925 to get ...

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 ...

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.