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

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 ...