Since it was established nearly a year ago by the FDA, the Commissioner’s National Priority Voucher (CNPV) program has been ...

In a bid to better deploy its boots-on-the-ground resources, the FDA is pulling back the curtain on a new pilot program, under which the regulator is leveraging “one-day inspectional assessments” to ...

On April 23, 2026, the Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) jointly announced the ...

Dr. Marty Makary, the FDA’s commissioner, said the program targets “dead time,” or about half the time between the launch of ...

Sanofi has asked the FDA to pull its type 1 diabetes drug out of Commissioner Marty Makary’s new speedy drug review program.

The U.S. Food and Drug Administration today issued an approval for Bizengri (zenocutuzumab-zbco), a drug that treats NRG1 fusion-positive cholangiocarcinoma, an ultra-rare, aggressive cancer that ...

On September 29, 2025, the U.S. Food and Drug Administration (FDA) announced the expansion of its Early Alert program to include all medical devices. This expansion builds on a pilot program that ...

The FDA has approved zenocutuzumab-zbco as the first drug for certain patients with a rare and aggressive bile duct cancer.

The US Food and Drug Administration (FDA) on Monday announced it will pilot a new program it hopes will spur the development of novel drug development tools (DDTs) that do not fit within the agency’s ...

Expedited development and review programs established by the US Food and Drug Administration (FDA) have a growing role in bringing drugs and biologics to market, with novel orphan and nonorphan ...