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 ...

A meeting held by the FDA Thursday spotlighted debate over black box warnings that have limited use of hormone treatment for ...

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

Leveraging a CDMO’s established platform for AAV manufacturing can significantly streamline gene therapy development.

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

Quarterly pharmaceutical sales surpassed $15 billion for the first time as strong performance from J&J's cancer medicines offset slumping Stelara sales.

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 ...