Browsing Tag
European Medicines Agency
66 posts
OneSource Specialty Pharma reports stellar Q3FY25 earnings with 85% EBITDA growth, setting stage for expansion
OneSource Specialty Pharma Limited, formerly Stelis Biopharma Limited, has delivered a strong financial performance in its first full…
Sanofi strengthens cardiovascular portfolio with Aficamten rights in Greater China
Cytokinetics, Incorporated (NASDAQ: CYTK) saw its shares climb by 4.8% after announcing a landmark agreement with Sanofi (NASDAQ:…
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…
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…
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.…
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…
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…
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…
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…
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…