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

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

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

Anavex Life Sciences Corp. expects feedback from the European Medicines Agency on blarcamesine for Alzheimer's Disease this ...

GOMEKLI™ is an oral, small molecule MEK inhibitor approved in the United States for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have ...

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

I would like to extend a warm welcome to Dan Kirby on behalf of the entire Iovance team,” stated Frederick Vogt, Ph.D., J.D., Interim President, Chief Executive Officer and board member of Iovance.

The euro is nearing a dollar parity once again, showing weakness as Donald Trump’s trade war continues with worldwide tariffs ...

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

Russia’s unjustified and unprovoked invasion of Ukraine and the weaponisation of energy have made diversification of energy supplies a necessity for EU countries. Diversification is a lengthy and ...

The two products, both manufactured by Amgen, are aflibercept biosimilars Pavblu and Skojoy. Both biosimilars are indicated ...

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