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

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

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

In looking across the past four years of regulatory decisions, we noticed that some of the analyses involving the European Medicines Agency (EMA)'s cycle time used an inappropriate endpoint ...

The EMA anticipates that the ability to access scientific advice will foster innovation among medical device manufacturers.

The European Medicines Agency said the portal will enable consultations with medical device expert panels that can promote faster access to new technologies.

Global biotechnology leader CSL (ASX: CSL; USOTC: CSLLY) and sa-mRNA pioneer Arcturus Therapeutics (Nasdaq: ARCT) today ...

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 ...

CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars:  On January 30, 2025, the European Medicines Agency (EMA) Committee ...

Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative ...

Czechia proposes changes that will better define the role of patient organisations when informing patients about therapeutic procedures without violating advertising regulations.

Ocugen (OCGN) said it has received a positive opinion from EU regulators for Advanced Therapy Medicinal Product ...