Vertex Pharma wins EU backing to expand label for Kaftrio cystic fibrosis drug
Vertex Pharmaceuticals (VRTX) stock in focus as company secures EU backing to expand label for its cystic fibrosis therapy ...
EU regulator reiterates positive recommendation for Eisai-Biogen's Alzheimer's drug
European Union's human medicines committee (CHMP) said on Friday it is not updating its opinion on Eisai and Biogen's ...
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 ...
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 ...
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] ...
AbbVie gets EU nod for its giant cell arteritis treatment
AbbVie (NYSE:ABBV) announced Friday that an expert panel of the EU drug regulator, the European Medicines Agency (EMA), ...
GlobalData on MSN15d
EU reshapes HTAs: is the industry ready for it?
New EU regulations aim to speed up health technology assessments (HTAs), but the pharma industry raises logistical concerns.
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, ...
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 ...