The EMA is set to perform accelerated reviews of Gilead Sciences’ applications for its twice-yearly injectable for HIV ...

| Avoid common pitfalls in EU orphan drug market access—learn how local expertise can help navigate pricing, reimbursement, ...

Russian attackers were behind the hack of the European Medicines Agency EMA in 2020. They had “unauthorized access to ...

New EU regulations aim to speed up health technology assessments (HTAs), but the pharma industry raises logistical concerns.

DIA's Europe Annual Meeting, featuring discussions from top European health leaders, will be held March 18-20 in Basel.

The European Medicines Agency has started a review of medicines containing finasteride and dutasteride following concerns ...

EMA establishes regular procedure for scientific advice on certain high-risk medical devices: Amsterdam, The Netherlands Wednesday, February 12, 2025, 13:00 Hrs [IST] EMA, in clos ...

C3i became the first contract development and manufacturing organization (CDMO) for cell and gene therapies in Canada to obtain a Drug Establishment License (DEL) to produce life-saving cell therapies ...

Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Sobi ® (STO:SOBI) today announced the European Medicines Agency (EMA) has validated an indication extension application for Aspaveli ® (pegcetacoplan) ...

C3i obtained a Drug Establishment License (DEL) to produce cell therapies for patients across Canada commercially.

Stockholm, Sweden Saturday, February 22, 2025, 09:00 Hrs [IST] ...

The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis' ...