FDA Commissioner Marty Makary’s proposal to roll out a new drug approval pathway is heightening hope for the rare disease ...

Qualification program creates a pathway to evaluate Clinical Outcome Assessments (COAs) that capture a specific concept of interest (COI) in a specified Context of Use (COU). If successfully qualified ...

U.S. pharmaceutical companies are increasingly licensing new drugs from China. Former FDA Commissioner Scott Gottlieb ...

Amit Chivate, senior market manager, Greater Asia and China, Roquette, provides his perspective on FDA’s recommendations ...

THE new Food and Drug Administration (FDA) application procedures are expected to reduce the drug permit process by as much as half ... “We need to build factories … because our research and ...

The use of RWD data in place of placebo groups is improving various elements across the clinical trial space.

MILAN, Italy, May 6, 2025 - Italfarmaco S.p.A. announced today that the U.S. Food and Drug Administration (FDA) has granted ...

"C-Path was built on the vision that no single entity can solve the challenges of the drug development process alone," said former C-Path ... and Impact From its early days supporting the FDA's ...

Activist Commentary: Elliott is a very successful and astute activist investor. The firm's team includes analysts from ...

President Trump issued an Executive Order (EO) titled “Regulatory Relief to Promote Domestic Production of Critical Medicines ...