Charlotte’s Web and DeFloria advance Autism treatment with FDA Phase 2 approval
Charlotte’s Web Holdings, Inc., a recognized leader in hemp-derived wellness products, has announced a major development in the pursuit of cannabinoid-based medical treatments. DeFloria, Inc., ... Read More
Mirum Pharmaceuticals gains FDA approval for Ctexli, the first drug for CTX
In a landmark decision, the U.S. Food and Drug Administration (FDA) has approved Ctexli (chenodiol) as the first treatment for cerebrotendinous xanthomatosis (CTX), a rare ... Read More
Harmony Biosciences faces FDA setback for pitolisant in idiopathic hypersomnia
Harmony Biosciences Holdings, Inc. has encountered a regulatory hurdle in its efforts to expand the use of pitolisant for the treatment of excessive daytime sleepiness ... Read More
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