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

Bio-Thera and Intas entered into a license and commercialization agreement for BAT2506 in February 2025. Under the terms of the agreement, Bio-Thera is responsible for the development and ...

Rocket Pharmaceuticals received a regenerative medicine advanced therapy designation from the Food and Drug Administration for its heart disease treatment.

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

Hansa Biopharma AB, "Hansa" (Nasdaq Stockholm: HNSA), today announced its interim report for January-June 2025.

The goal with ProKidney's rilparencel-branded therapy is “to demonstrate the therapy’s potential to preserve kidney function in patients with advanced chronic kidney disease and diabetes.” ...

Sarepta Therapeutics said it will eliminate 36% of its workforce—approximately 500 jobs—in a restructuring that follows the ...

Following the death of two teenage patients with Duchenne muscular dystrophy following Elevidys treatment, Sarepta ...

Acquisition provides I-Mab with upstream rights to CLDN18.2 parental antibody for use in bispecific and multi-specific applications <li ...

Sarepta Therapeutics shares surged 34% in after-hours trading on Wednesday after the company said it would slash 500 jobs, or ...

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced a strategic restructuring plan ...

So far, eight children have been born, all reportedly healthy, thanks to the long-term efforts of scientists and doctors in ...