Germany's Merck KGaA has struck a deal to buy U.S. biotech company SpringWorks Therapeutics for an equity value of $3.9 ...

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 ...

Patients with compensated MASH cirrhosis who develop clinically significant portal hypertension are at greatly elevated risk of experiencing life-threatening complications of late-stage liver disease ...

On VRTX's first-quarter earnings call, investors are likely to focus on the launch preparation for Alyftrek (vanza triple) ...

Travere Therapeutics, Inc., (NASDAQ: TVTX) and CSL Vifor are pleased to announce that the European Commission has approved the conversion of the conditional marketing approval (CMA) into a standard ...

European Commission converts conditional approval of FILSPARI (sparsentan) into standard marketing authorization for the treatment of IgA Nephropathy (IgAN) Decision follows positive recommendation ...

CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) are pleased to announce that the European Commission has approved ...

Alnylam Pharmaceuticals (NasdaqGS:ALNY) experienced an 8% price increase over the past week, likely spurred by a positive opinion from the European Medicines Agency (EMA) regarding its RNAi ...

Italfarmaco's oral HDAC inhibitor Duvyzat has been recommended for approval in the EU as a treatment for Duchenne muscular ...

Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy ...

Were that to happen, the EU would risk losing what makes it truly influential in the world: its global regulatory superpower. The EU determines national and corporate regulatory standards in many ...