Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for ...

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

Two former FDA leaders look at Commissioner Marty Makary’s early stumbles — and lay out a list of priorities to protect both ...

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

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

On a recent call with analysts at BMO Capital Markets, a “former director” at the FDA’s Center for Biologics Evaluation and ...

Vanda Pharmaceuticals is suing the FDA again, this time alleging the agency is unlawfully delaying a hearing to discuss the ...

In recent weeks, biotech companies have faced setbacks in moving forward with clinical trials due to operational delays at the FDA, according ... jeopardize potential product launches — issues ...

Significant proposed regulatory changes within the U.S. Food and Drug Administration (FDA), along with large layoffs that ...

Donald Trump takes biopharma on a tariff-themed rollercoaster ride; J&J kicks off the Q1 earnings season; experts express ...

They cited concerns about a possible link between consumption of the dyes and health conditions like ADHD, obesity and ...