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

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

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

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

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

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

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

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

Abu Dhabi has set a 2030 roadmap to achieve ambitious global reproductive health ecosystem goals. Prevention and ...

Even though the trastuzumab biosimilar market is already established in Brazil, the latest Anvisa approval marked an ...

A former FDA review official argued the Accelerating Rare Disease Cures initiative has demonstrated its value, but must ...

Sponsors seeking to use the US FDA’s plausible mechanism framework for individualized therapies must show that a randomized ...