Hosted on MSN3h
FDA RMAT designation for Beacon’s retinitis pigmentosa treatment
The US Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to Beacon ...
GSK announces EMA accepted for review the MAA for depemokimab
GSK (GSK) announced that the European Medicines Agency, EMA, has accepted for review the Marketing Authorisation Application, MAA, for the use of depemokimab in two indications. The submitted indicati ...
Pharm Exec8h
Treating Disruptive Symptom’s in Crohn’s Patients: Q&A with Mark Genovese, MD
Mark Genovese: Crohn’s disease is a chronic, inflammatory bowel disease associated with progressive bowel damage, disability, ...
GSK says asthma and nasal polyps therapy under EU review
GSK (GSK) stock in focus as its experimental drug depemokimab undergoes EU review for asthma and nasal polyps. Read more here ...
EU medicines agency quits X, moves to Bluesky
The European Medicines Agency (EMA) said on Monday it would no longer post on X and would use rival Bluesky instead, becoming ...
FiercePharma5d
Seeking new social media horizons, EMA joins mass migration from X to Bluesky
As users continue to leave X (formerly Twitter) en masse, many in favor of the newer Bluesky platform, the European Medicines ...
X4 Pharmaceuticals announces EMA validation of MAA for mavorixafor
X4 Pharmaceuticals (XFOR) announced that its Marketing Authorization Application for mavorixafor for the treatment of WHIM syndrome, a rare ...
Managed Healthcare Executive5d
FDA and EMA Accepts Applications for New Nusinersen Regimen
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines ...
BioSpace6d
Biogen Trims Research Workforce, Higher-Dose SMA Drug Accepted for Regulatory Review
In a good-news-bad-news week for Biogen, the company will cut an undisclosed number of employees, just as a higher dose of ...
FDA and EMA review Biogen's higher dose SMA drug
CAMBRIDGE, Mass. - Biogen Inc. (NASDAQ:BIIB), a $20.8 billion biotechnology company with a robust 75.6% gross profit margin, ...
Biogen Gets U.S., European Reviews of Higher-Dose Spinraza
Biogen said the U.S. Food and Drug Administration has accepted its supplemental new-drug application, while the European Medicines Agency has validated its application, which confirms that the ...