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 ...

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 ...

Eli Lilly and Company LLY announced that the FDA has granted a Breakthrough Therapy designation to its novel folate receptor alpha (FRα) antibody-drug conjugate (ADC), sofetabart mipitecan (LY4170156) ...

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 ...

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 ...

Shares of Pyxis Oncology (NASDAQ:PYXS) traded higher in the premarket on Wednesday after the U.S. FDA issued its Fast Track Designation for the company’s lead candidate, PYX-201, targeted at head and ...