The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for ...

Q4 2024 Earnings Call Transcript February 6, 2025 Neurocrine Biosciences, Inc. misses on earnings expectations. Reported EPS ...

Supernus Pharmaceuticals' FDA approval for ONAPGO in Parkinson's Disease offers optimism despite past challenges, with a ...

Groundbreaking personalized kidney cancer vaccines show promise in early clinical trials, triggering strong immune responses ...

Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...

EBR Systems is super confident the US medical gatekeeper will approve Wise, the world's first wireless pacemaker device.

Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...

Less than two months after an accelerated approval from the FDA, a drug combination featuring Pfizer’s Braftovi has turned in ...

Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...

Trump's pick for HHS secretary who endured confirmation hearings last week—has repeatedly criticized industry ties to the FDA ...

You may have heard in the news that the U.S. Food and Drug Administration will no longer allow the use of FD&C Red Dye No. 3 ...

The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.