Clarity Pharmaceuticals bags FDA fast track designation for prostate cancer candidate 67Cu-SAR-bisPSMA
Clarity Pharmaceuticals has achieved a major regulatory milestone with the United States Food and Drug Administration (FDA) granting Fast Track Designation to 67Cu-SAR-bisPSMA, a targeted ... Read More
FDA grants Breakthrough Therapy Designation to Lacutamab for Sézary Syndrome
Innate Pharma has achieved a significant regulatory milestone with the U.S. Food and Drug Administration (FDA) granting Breakthrough Therapy Designation for lacutamab, a first-in-class anti-KIR3DL2 ... Read More
Axsome Therapeutics wins big in Auvelity patent battle, stock jumps 14%
Axsome Therapeutics Inc. experienced a sharp rise in its share price, climbing 14% in premarket trading following the announcement of a settlement agreement with Teva ... Read More
FDA approves EMBLAVEO to combat complicated intra-abdominal infections with limited treatment options
The U.S. Food and Drug Administration (FDA) has granted approval for EMBLAVEO (aztreonam and avibactam), marking a significant milestone in the fight against complicated intra-abdominal ... Read More
Lipella Pharmaceuticals secures FDA approval for expanded access program for LP-310 in oral lichen planus
Lipella Pharmaceuticals Inc., a clinical-stage biotechnology company dedicated to addressing unmet medical needs, has announced that it has received approval from the U.S. Food and ... Read More
Vaxart’s oral COVID-19 vaccine gains momentum with DSMB approval
Vaxart, Inc., a clinical-stage biotechnology company headquartered in South San Francisco, has announced a critical advancement in its innovative oral COVID-19 vaccine candidate. An independent ... Read More
Boston Scientific to expand cardiovascular portfolio with Bolt Medical acquisition
Boston Scientific Corporation has announced a definitive agreement to acquire Bolt Medical, Inc., a developer of cutting-edge intravascular lithotripsy (IVL) technology. The acquisition reflects Boston ... Read More
Corcept Therapeutics submits FDA application for relacorilant to treat Cushing’s syndrome
Corcept Therapeutics Incorporated has taken a significant step in addressing the unmet needs of patients with hypercortisolism, commonly known as Cushing’s syndrome. The biopharmaceutical company ... Read More
FDA approves Opdivo Qvantig, a new subcutaneous immunotherapy option for cancer treatment
In a significant advancement for oncology care, the U.S. Food and Drug Administration (FDA) has approved Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) for subcutaneous use. This ... Read More
FDA approves first generic liraglutide injection for Type 2 diabetes treatment
In a significant milestone for diabetes care, the U.S. Food and Drug Administration (FDA) has approved the first generic equivalent of liraglutide injection, a glucagon-like ... Read More