With the robust demand for personalized medicines and the growing adoption of digital technology, the precision medicine ...

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 ...

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 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 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 ...

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 ...

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

Data on mRNA vaccines sent by Moderna to European regulators before the COVID-19 outbreak included early tests of the mRNA platform to treat or prevent diseases such as cancer. They did not include ...

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 ...