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 ...

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

The agency leveraged subcutaneous semaglutide’s STEP and SELECT data to grant the first GLP-1 obesity pill its weight loss ...

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

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

New proposal from the European Commission will require member states to take a personalized, accessible approach to screening ...

The company announced positive Phase II data for the BCMA-directed CAR-T therapy in patients with relapsed/refractory AL ...

At an upcoming meeting, a Cosmetic Ingredient Review panel is slated to review safety assessments of two prostaglandin ...

Global regulators are sharing more intelligence on manufacturers of active pharmaceutical ingredients to strengthen ...

New EU guidance aims to simplify safety reporting for studies of products that combine a drug and diagnostic or a drug and ...

Louisiana Medicaid likely saved more than $200m by using a hepatitis C “subscription” contract model from 2019 to 2024, an ...