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Capricor Therapeutics Inc. and its CEO overhyped regulatory approval odds for its cell therapy to treat a serious heart ...
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FDA Advisory Panel Votes Against Approval of GSK's Blenrep ComboGSK plc GSK announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the overall benefit/risk ...
In briefing documents released ahead of an Advisory Committee meeting this week, FDA staffers cited safety risks related to a ...
Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative ...
The FDA has accepted for priority review a new supplemental biologics license application for Winrevair to treat adults with ...
Nanoscope Therapeutics submitted the first modules of a biologics license application for MCO-010, an investigational gene ...
The goal with ProKidney's rilparencel-branded therapy is “to demonstrate the therapy’s potential to preserve kidney function ...
RED BANK, N.J., April 8, 2021 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced ...
The Biologics License Application for full licensure of the Moderna COVID-19 vaccine, mRNA-1273, for active immunization to prevent COVID-19 in individuals 18 years of age and older has been ...
RED BANK, N.J., April 27, 2021 /PRNewswire/ -- Provention Bio, Inc., (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced ...
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