The European drug authority recommends refusal of marketing authorization due to evidence gaps in quality and efficacy.

The drug failed to meet its primary endpoints in clinical trials, but subgroup analyses hinted at modest benefits.

MetrioPharm’s lead compound, MP1032, has received ODD from the European Medicines Agency (EMA) for treating DMD in children.

OncoZenge AB (publ) ("OncoZenge" or "the Company") today announced a comprehensive market and strategy update after successfully securing full funding for its BupiZenge Phase 3 clinical trial aimed at ...

Sarepta will begin shipping its top-selling muscular dystrophy therapy, Elevidys, after the U.S. Food and Drug Administration ...

Bausch Health to acquire DURECT Corporation, strengthening commitment to developing innovative solutions for patients with liver disease: Laval, Quebec Wednesday, July 30, 2025, 1 ...

Swiss drugmaker Roche Holding plans to investigate whether an experimental medicine can delay or prevent Alzheimer’s disease ...

Once touted as a potential powerhouse treatment for a variety of inflammatory conditions, Galapagos’ JAK inhibitor Jyseleca ...

Bausch Health is buying late-stage biopharmaceutical company Durect for about $63 million in cash up front, plus two possible additional payments totaling up to $350 million.

Alfasigma is in discussions with the EMA and MHRA about Jyseleca for axSpA but has yet to reveal any plans for US submission.

Sarepta continues to work with regulators to complete the safety label update for Elevidys, and they are discussing an approach for risk mitigation for non-ambulatory patients.

Though India has built a robust domestic biosimilar market, its international presence and the ability to lower prices as ...