The agency is missing deadlines and not responding to biotech companies, forcing some to push back clinical trials.

The FDA announced it will be reducing, refining and potentially replacing the animal testing requirement for the approval of ...

The FDA announced a shift away from animal testing for drug approval, citing advanced alternatives like AI and organoids ...

After the gutting of the Department of Health and Human Services, fears mount about the future direction of the FDA—with ...

Concern is growing among public health experts that anti-vaccine sentiments within federal and state governments may derail ...

In 2024, the FDA's Center for Drug Evaluation and Research (CDER) approved 50 new drugs. The CDER director, Patrizia ...

This blog delves into the rise of rare disease drug approvals and the critical importance of regulatory guidance in shaping ...

After mass layoffs, the FDA has started missing certain deadlines, pushing one biopharma to delay a phase 3 trial and ...

Health Secretary Robert F. Kennedy Jr. announced wide-ranging cutbacks at federal health agencies, including the Food and ...

CMG Pharmaceutical, an affiliate of Cha Biotech, announced Wednesday that its oral film-type antipsychotic drug has received ...

Many of the directions included in the order will be familiar to those who watched drug pricing policy closely during the ...

The Supreme Court backed the FDA's refusal to authorize the sale of kid-friendly flavored vapes, including the flavors ...