Browsing Tag
European Medicines Agency
91 posts
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…
October 22, 2024
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…
October 13, 2024
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…
August 16, 2024
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…
August 9, 2024
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…
July 30, 2024
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)…
April 28, 2024
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…
April 28, 2024
Arcturus Therapeutics’ ARCT-032 gets EU’s orphan medicinal product designation for cystic fibrosis
Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT), a leading global clinical-stage messenger RNA medicines company, has achieved a significant…
February 22, 2024
Genmab, Pfizer’s tisotumab vedotin takes a leap towards EU approval for cervical cancer
In a significant development for cervical cancer treatment, Genmab A/S (Nasdaq: GMAB) and Pfizer, Inc. (NYSE: PFE) have…
February 5, 2024
Advancing bladder cancer treatment: EMA scrutinizes Astellas-Pfizer’s innovative therapy
A groundbreaking development in bladder cancer treatment is on the horizon as Astellas Pharma Inc. and Pfizer Inc.…
January 28, 2024