Analysts questioned whether the complete response letter Replimune received was evidence of changing approval standards at ...

The French pharma will pay $1.15 billion upfront to buy Vicebio and gain access to non-mRNA vaccine candidates against RSV, ...

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

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

George Tidmarsh, a Stanford University physician who founded Horizon Pharma and later ran La Jolla Pharma, was named head of ...

Company CEO Doug Ingram said the pause was necessary for Sarepta to maintain a "productive and positive working relationship" ...

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

A standoff over Elevidys could have major consequences for Duchenne patients, gene therapy companies and the perception of ...

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

While Stelara is used in fewer indications than Humira, it commands a large market share in its therapeutic areas, most ...

The death of a 51-year-old man in the study follows two other deaths of Duchenne patients treated with Sarepta’s marketed ...

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