Browsing Tag
U.S. Food and Drug Administration
103 posts
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…
Medtronic receives FDA clearance for innovative Smart MDI system with Simplera CGM integration
Medtronic plc has received U.S. Food and Drug Administration (FDA) clearance for its innovative Smart Multiple Daily Injection…
FDA accepts Bayer’s application to expand NUBEQA’s use in prostate cancer treatment
The U.S. Food and Drug Administration (FDA) has accepted Bayer’s supplemental new drug application (sNDA) for NUBEQA (darolutamide),…