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

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

The French biotech is developing a new drug approach in a disease market that’s projected to grow to $30 billion by 2030.

Experts on the panel shared many of the same views around SSRIs, arguing the risks of the drugs during pregnancy are greater ...

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

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

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

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

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

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 ...

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