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 ...

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 ...

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 ...

Fate Therapeutics FATE recently announced that the FDA has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational pipeline candidate FT819 for the treatment of ...

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 ...

Rocket Pharmaceuticals RCKT announced that the FDA has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational adeno-associated virus (AAV)-based gene therapy, ...

Elon Musk’s brain-chip startup Neuralink said on Tuesday its experimental implant aimed at restoring vision received the U.S. Food and Drug Administration’s “breakthrough device” designation. 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 ...