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 ...

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global ...

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

After a 20% cut to the FDA’s workforce, biotechs and pharmas are bracing for delays. But the impacts won’t be consistent.

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 ...

Animal testing requirements for monoclonal antibodies and other medications will be “reduced, refined or potentially replaced” in favor of other approaches, including artificial intelligence, ...

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

To get FDA approval, scientists must be able to demonstrate that a new drug or ... the evaluation process, while reducing animal experimentation, lowering research and development (R&D) costs ...

HHS Secretary Kennedy and FDA Commissioner Makary signal movement away from animal testing while a group of bipartisan lawmakers introduces the FDA Modernization Act 3.0 Washington D.C., April 10, ...

The expiration of the FDA’s paediatric priority review voucher programme is creating uncertainty for rare disease drug ...