Browsing Tag
U.S. Food and Drug Administration
105 posts
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…
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…
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…
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…
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…
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…
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…
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…
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…
Vanda Pharmaceuticals’ VGT-1849A gets orphan drug designation for polycythemia vera treatment
Vanda Pharmaceuticals Inc. has achieved a critical regulatory milestone with the U.S. Food and Drug Administration (FDA) granting…