Gilead Sciences (GILD) said on Friday that the European Commission (EC) granted conditional marketing authorization for ...

FDA approves an expanded access program that would offer patients an alternative to Merck’s bladder cancer medication.

Biliary tract cancer is increasing in incidence and mortality across Europe, with more people under the age of 60 years old ...

Krystal Biotech KRYS reported fourth-quarter earnings per share of $1.52, which beat the Zacks Consensus Estimate of $1.29 as ...

The evolution of cell and gene therapy is reshaping drug discovery, providing new hope for rare diseases and cancer through innovative gene editing approaches.

Apellis (APLS) and Sobi announced the European Medicines Agency has validated an indication extension application for Aspaveli for the ...

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) ...

The EU regulates the authorisation of medicines at EU level by the European Medicines Agency or at national level by the competent authorities in EU countries. Special rules exist for the ...

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

On 20 December 2021, the EU authorised the first protein-based vaccine (produced by Novavax) for use in the EU, following a positive recommendation of the European Medicines Agency. The Novavax ...

Adaptive pathways have also been proposed to accelerate the introduction of innovative medicines in Europe (53, 54). However, there are considerable concerns among European payers in this regard, and ...