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Solid Biosciences Inc. SLDB announced that the FDA has granted a Rare Pediatric Disease Designation to its next-generational investigational candidate, SGT-003, which is being developed as a gene ...
Johnson & Johnson JNJ announced that the FDA has granted a Fast Track designation (“FTD’) to its investigational drug, nipocalimab, for treating adult patients with moderate-to-severe Sjögren’s ...
A monthly antibody drug to treat sickle cell disease, developed by Novartis, has won a coveted breakthrough designation from the FDA as it heads towards its first regulatory filings. The US regulator ...
Ionis Pharmaceuticals IONS announced that the FDA has granted the Breakthrough Therapy designation to its pipeline candidate, ION582, for the treatment of Angelman syndrome (AS), a rare neurological ...
NEW YORK - OS Therapies Inc. (NYSE-A: OSTX), a biotechnology firm specializing in cancer immunotherapies with a current market capitalization of $45.8 million, has requested the U.S. Food and Drug ...
uniQure (NASDAQ:QURE) shares added ~39% in the premarket on Thursday after the Dutch biotech announced that the FDA granted Breakthrough Therapy designation for its gene therapy candidate AMT-130. The ...
TGW101 est un CAM de nouvelle génération de première classe ciblant TAG-72 avec une charge utile de MMAE, développé sur la base de la chimie de liaison Click-to-Release exclusive de Tagworks; TGW101 ...
Food and Drug Administration Commissioner Marty Makary signed off on the ouster of top vaccine official Peter Marks shortly after being quietly sworn in as the agency’s new leader late last week, four ...