Three biosimilars by Celltrion near EU approval following CHMP endorsement
Celltrion, a leading South Korean biopharmaceutical company, has received positive opinions from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) ... Read More
Breakthrough EU approval for Dupixent offers new hope for children with eosinophilic esophagitis
The European Medicines Agency (EMA) has granted approval for Dupixent, a therapy developed by Sanofi and Regeneron, to treat eosinophilic esophagitis (EoE) in children as ... Read More
Ionis Pharmaceuticals moves forward with FDA review of donidalorsen for HAE
In a significant development for hereditary angioedema (HAE) patients, Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced that the U.S. Food and Drug Administration (FDA) has accepted ... Read More
FDA approval pathway propels Sangamo Therapeutics shares upward: what’s next?
Sangamo Therapeutics experienced a significant surge in its stock price, jumping by as much as 53%, after the U.S. Food and Drug Administration (FDA) indicated ... Read More
FDA approves Pfizer’s HYMPAVZI for breakthrough hemophilia treatment
In a major leap for hemophilia patients, Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has granted approval for HYMPAVZI ... Read More
Could vimseltinib be the next big thing in TGCT treatment? FDA says Yes!
The U.S. Food and Drug Administration (FDA) has granted priority review status to Deciphera Pharmaceuticals, Inc.'s New Drug Application (NDA) for vimseltinib, a drug developed ... Read More
Game-changer for kidney disease: Novartis’ Fabhalta wins FDA approval in record time
Novartis has reached a pivotal moment in the treatment of rare kidney diseases with the US Food and Drug Administration (FDA) granting accelerated approval for ... Read More
Dr. Reddy’s Laboratories secures key European endorsement for Rituximab biosimilar
In a significant development for the pharmaceutical industry, Dr. Reddy’s Laboratories Ltd. has received a positive opinion from the European Medicines Agency’s (EMA) Committee for ... Read More
Amgen seeks European approval for teprotumumab in thyroid eye disease
Amgen (NASDAQ: AMGN), a global biotechnology leader, has announced its plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ... Read More
Bristol Myers Squibb’s Opdivo set for EMA approval in urothelial carcinoma
Bristol Myers Squibb (NYSE: BMY), a global leader in biopharmaceuticals, has reached a significant milestone with the Committee for Medicinal Products for Human Use (CHMP) ... Read More