TL1A inhibition is a competitive area of R&D. Merck has the lead in IBD with tulisokibart, and new Phase II data support a ...

The FDA urged sponsors to “step up and start doing the studies” during a workshop that was a return to more science-based ...

With new Phase II atopic dermatitis data for the IL-13 blocker, AbbVie plans to compete with Dupixent and Ebglyss in ...

The FDA has opened recruitment for voting and nonvoting device advisory committee members, with consumer representative spots ...

The US FDA approved Camzyos (mavacamten) for pediatric patients with obstructive hypertrophic cardiomyopathy, giving the drug ...

The drugmaker presented Phase IIIb data for the IL-13 inhibitor at EADV in patients with atopic dermatitis with hand and foot ...

ARPA-H launched the SURPASS program, which will use advanced computing, modeling and other techniques to streamline and ...

A nationwide nomination push is a sharp break from former Commissioner Martin Makary’s aversion to advisory committees, even ...

GSK’s rising oncology ambitions face headwinds in India, with Natco challenging the validity of the patent underpinning ...

A layer of legal oversight of the US Food and Drug Administration has been removed, potentially giving more freedom to its ...

Oncology accounted for a quarter of all novel application withdrawals over the past decade and accelerated approval is the ...

At its capital markets day at the London Stock Exchange earlier this month, Sandoz set out plans to have 100 biosimilars in ...