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 ...

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 ...

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 ...

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 ...

Altimmune ALT announced that the FDA has granted Breakthrough Therapy Designation to its lead pipeline candidate, pemvidutide, a novel, investigational GLP-1/glucagon dual receptor agonist, for the ...