EU regulator reiterates positive recommendation for Eisai-Biogen's Alzheimer's drug
The European Union's medicines regulator on Friday reiterated its positive recommendation for Eisai and Biogen's Alzheimer's ...
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), ...
Euronews2d
The European Medicines Agency EMA has not 'admitted' that mRNA vaccines are 'experimental'
A false claim is circulating online that the European Medicines Agency (EMA) has acknowledged that mRNA vaccines have not been formally approved and that millions have therefore been vaccinated ...
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 MSN16d
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.
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 ...
pharmaphorum3d
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 ...
emjreviews.com6d
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 ...
FierceBiotech6d
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, ...
Pharmabiz5d
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] ...
Medscape1mon
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 ...