The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could ...

AstraZeneca’s top medical executive Cristian Massacesi will replace Bristol Myers’ current chief medical officer, Samit ...

The $50 billion target, which AstraZeneca plans to meet by 2030, includes new manufacturing projects in Virginia and ...

The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...

The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and ...

Lilly’s appeal of an earlier, negative recommendation from a key EMA committee has worked out in its favor, and puts the drug ...

While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency ...

The startup is using elements of gene and cell therapy to create medicines that could be useful against an array of ...

The pharma sees the drug, gefurulimab, as a more convenient, self-administered alternative to the infused medicines it sells ...

The Swiss company, which markets Elevidys abroad, said it believes the benefit-risk balance to treatment remains positive in ...

TCG Labs Soleil, which launched in 2024 in collaboration with The Column Group, is focused on building single-drug biotechs ...

Part of a class of therapies that boost “orexin” proteins, the drug just scored positive results in a Phase 2 trial. Analysts ...