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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 ...
Silence Therapeutics’ efforts to push SLN124 as a potential treatment for myelodysplastic syndrome (MDS) may have hit a roadblock earlier this year, but the FDA appears to have faith in the therapy’s ...
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 ...
The lawsuit was filed in Baton Rouge, Louisiana, state court by plaintiffs including the New Orleans-based Birthmark Doula Collective, a doctor, a pharmacist, and women who said they were denied ...
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 ...
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 ...
Australian biotech Kazia Therapeutics (NASDAQ:KZIA) added ~29% pre-market Thursday after announcing that the FDA issued Fast Track Designation for its lead program, paxalisib, in combination with ...
The US Food and Drug Administration (FDA) has awarded Neuralink’s brain-computer interface breakthrough device designation for the treatment of individuals with severe speech impairment. The FDA tag ...
Sorrento Therapeutics’ SRNE subsidiary Scilex Holding Company recently received Fast Track designation from the FDA for investigational drug and device product candidate SP-103 (lidocaine topical ...
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Here's a roundup of top developments in the biotech space over the last 24 hours: Stocks In Focus Eisai - Biogen's Alzheimer's Candidate Under FDA Priority Review The FDA has accepted Eisai Co Ltd ...