TCTMD2d
European Medicines Agency Investigating GLP-1 Drugs and Eye Disease
A safety committee will review all evidence from trials and studies to shed more light on the potential risk of NAION.
X4 Pharmaceuticals Announces EMA Validation of Marketing Authorization Application (MAA) for Mavorixafor for the Treatment of WHIM Syndrome
Submission supported by positive results from global, Phase 3 4WHIM clinical trial; U.S. regulatory approval in WHIM syndrome ...
Managed Healthcare Executive15h
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 Agency (EMA) considerate it as an alternative than the current lower ...
Fact Check: Rise in under-50s cancer diagnoses predates COVID-19 vaccines
Rising diagnoses of certain cancers in people under 50 predate the rollout of COVID-19 vaccines by decades, undermining ...
Biogen Says FDA And EMA Accept Applications For Higher Dose Regimen Of Nusinersen In SMA
Biogen Inc. (BIIB) announced Thursday that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New ...
NL Times6d
European Medicines Agency to investigate link between Ozempic and rare eye disorder
The safety committee of the European Medicines Agency (EMA) will again study the medication, semaglutide, out of concerns ...
Biogen announces FDA, EMA accepted applications for higher dose of nusinersen
Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted the company’s supplemental New Drug Application, sNDA, ...
BioSpace22h
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 ...
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 ...
Acadia Pharmaceuticals Submits Marketing Authorization Application to the European Medicines Agency for Trofinetide for the Treatment of Rett Syndrome
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for trofinetide for the ...
TMCnet1d
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
We are pleased to announce that our applications for the higher dose regimen of nusinersen are now under review in the US and Europe,” said Stephanie Fradette, Pharm.D., Head of the Neuromuscular ...
Pharmabiz6d
In 2024 EMA recommends 114 medicines for marketing authorisation; 46 had a new active substance
EMA recommends 114 medicines for marketing authorisation; 46 had a new active substance: Amsterdam, The Netherlands Saturday, January 18, 2025, 13:00 Hrs [IST] European Me ...