Since it was established nearly a year ago by the FDA, the Commissioner’s National Priority Voucher (CNPV) program has been ...
On April 23, 2026, the Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) jointly announced the ...
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 ...
Dr. Marty Makary, the FDA’s commissioner, said the program targets “dead time,” or about half the time between the launch of ...
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 ...
Forbes contributors publish independent expert analyses and insights. Greg Licholai writes and teaches about innovation in healthcare. In a set of policy measures that aim to combine speed with cost ...
The FDA has approved zenocutuzumab-zbco as the first drug for certain patients with a rare and aggressive bile duct cancer.
WASHINGTON (AP) — The Food and Drug Administration commissioner’s effort to drastically shorten the review of drugs favored by President Donald Trump’s administration is causing alarm across the ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
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 ...
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