The drug receives conditional marketing authorization by the CHMP for the treatment of HER2-positive biliary tract cancer.

At its April 2025 meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) gave ...

In addition, Eisai must conduct a post-authorization safety study, including setting up a patient registry for the European Union. Now each European country must set its own rules for access and ...

Merck KGaA acquires SpringWorks Therapeutics, Inc. for $3.9B, boosting its pipeline with OGSIVEO & GOMEKLI. Click for more on ...

Acoramidis is an orally administered selective small molecule that stabilises transthyretin (TTR) by more than 90%. This ...

A regulatory committee has recommended that Duvyzat be approved in the European Union as a treatment for Duchenne muscular ...

The Italian Medicines Agency is ready to evaluate the reimbursement of new drugs against obesity, following the British model ...

The company said that Vyvgart (efgartigimod alfa) is the first novel mechanism of action for CIDP treatment in more than 30 years.

The company expects the European Commission (EC) to make a final decision on the marketing authorization in June 2025.

After issues at a third-party manufacturer caused the FDA to reject Regeneron's multiple myeloma bispecific antibody ...

Krystal Biotech, Inc. (the "Company”) (NASDAQ: KRYS) announced today that on April 23, 2025, the European Commission (EC) granted marketing authorization to VYJUVEK ® (beremagene geperpavec-svdt) for ...

EMA grants conditional marketing authorization to Italfarmaco’s Duvyzat to treat Duchenne muscular dystrophy: Amsterdam, The Netherlands Monday, April 28, 2025, 16:00 Hrs [IST] ...