News

Capricor Investor Sues After Disappointing FDA Return on Therapy
Capricor Therapeutics Inc. and its CEO overhyped regulatory approval odds for its cell therapy to treat a serious heart ...
Sarepta's Setback Deepens With Another Gene Therapy Fatality
Sarepta Therapeutics (NASDAQ:SRPT) shares plummeted on Friday following reports of a third patient death linked to its gene ...
Zacks Investment Research on MSN1d
FDA Advisory Panel Votes Against Approval of GSK's Blenrep Combo
GSK plc GSK announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the overall benefit/risk ...
Bio-Thera Solutions Announces FDA Accepts Biologics License Application for BAT2506, a Proposed Biosimilar to Simponi®
Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative ...
Healio8d
FDA accepts new supplemental biologics license application for review for Winrevair
The FDA has accepted for priority review a new supplemental biologics license application for Winrevair to treat adults with ...
Healio5d
Nanoscope begins rolling submission of biologics license application for RP gene therapy
Nanoscope Therapeutics submitted the first modules of a biologics license application for MCO-010, an investigational gene ...
Pulmonology Advisor1d
FDA to Review Arexvy for 18 to 49-Year-Olds at Increased RSV Disease Risk
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.
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FDA Accepts Biologics License for Proposed Biosimilar to Simponi
The U.S. FDA has accepted a Biologics License Application (BLA) for BAT2506, a proposed biosimilar to Simponi (golimumab).
Winston-Salem Journal3d
ProKidney gains pivotal therapy advancement step with FDA
The goal with ProKidney's rilparencel-branded therapy is “to demonstrate the therapy’s potential to preserve kidney function ...