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 ...

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

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 ...

Adam Feuerstein, a senior writer and biotech columnist, is the author of Adam’s Biotech Scorecard, a subscriber-only newsletter about the crossroads of drug development, business, Wall Street ...

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

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, ...

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 ...