Honolulu Star-Advertiser2h
EU regulator reiterates positive recommendation for Alzheimer’s drug
The European Union’s medicines regulator on Friday reiterated its positive recommendation for Eisai and Biogen’s Alzheimer’s ...
Vertex Pharma wins EU backing to expand label for Kaftrio cystic fibrosis drug
Vertex Pharmaceuticals (NASDAQ:VRTX) announced Friday that an expert panel of the EU drug regulator, the European Medicines ...
Valneva Receives EMA’s Positive CHMP Opinion for Adolescent Label Extension for Chikungunya Vaccine IXCHIQ®
If granted, IXCHIQ® will become the first vaccine against the chikungunya virus (CHIKV) available in the EU for adolescents 12 years of age and ...
Linvoseltamab Recommended for EU Approval by the CHMP to Treat Relapsed/Refractory Multiple Myeloma
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion ...
Novartis announces CHMP of EMA adopted positive opinion for Fabhalta
Novartis (NVS) announced that the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, has adopted a ...
pharmaphorum2d
EMA’s strategy for speeding up drug approvals in the EU
The EMA is implementing major changes to accelerate drug approvals in the EU, addressing delays that affect patients and businesses alike. Following a turbulent period marked by Brexit and the ...
The Parliament Magazine4dOpinion
Op-ed: A critical medicine shortage calls for better EU collaboration
With the European Medicines Agency identifying shortages in more than 30 critical medicines, the single market presents an ...
GlobalData on MSN4d
Gilead’s lenacapavir applications for HIV gain EMA validation
The latest announcement follows the recent US Food and Drug Administration (FDA) acceptance of the company’s new drug ...
emjreviews.com5d
EMA grants accelerated review to Gilead’s PrEP drug
The EMA is set to perform accelerated reviews of Gilead Sciences’ applications for its twice-yearly injectable for HIV ...
FierceBiotech5d
5 Market Access Mistakes That Can Derail Your EU Orphan Drug Launch
| Avoid common pitfalls in EU orphan drug market access—learn how local expertise can help navigate pricing, reimbursement, ...
Pharmabiz4d
EMA validates Gilead’s MAA and EU-Medicines for all application for twice-yearly lenacapavir for HIV prevention
Foster City, California Tuesday, February 25, 2025, 16:00 Hrs [IST] ...
Medscape29d
EMA Expedites Adolescent Chikungunya Vaccine Recommendation
In its first meeting of 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) gave the green light for the first vaccine in the EU to protect adolescents ...