US Food and Drug Administration (FDA) Accepts Application for Opdivo Plus Low-Dose Yervoy for Treatment of First …

US Food and Drug Administration (FDA) Accepts Application for Opdivo Plus Low-Dose Yervoy for Treatment of First …

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) for the treatment of first-line advanced non-small cell lung cancer (NSCLC) in patients with tumor mutational burden (TMB) ≥10 mutations per megabase (mut/Mb). […]

Fort Collins kid helped new drug get FDA approval

Fort Collins kid helped new drug get FDA approval

Noah Colbert, 12, of Fort Collins, has cystic fibrosis. He participated in a clinical trial to test Symdeko, a drug designed to help improve lung function. The FDA approved Symdeko February 2018. Thanks to that research, more people will be able to manage their disease. Wochit Source link

White House proposes a narrowing of FDA's mission — and a new name

White House proposes a narrowing of FDA's mission — and a new name

W ASHINGTON — The Trump administration has proposed a fundamental change to the mission of the Food and Drug Administration, one that would transfer most of the responsibility for regulating food safety to the Department of Agriculture and rename the FDA the “Federal Drug Administration.” The proposal is part of a wide-reaching plan that was […]

FDA pressured to revoke Takeda's popular gout drug Uloric due to death concerns

FDA pressured to revoke Takeda's popular gout drug Uloric due to death concerns

When Takeda’s gout drug Uloric (febuxostat) was approved by the FDA, it was with a requirement for postmarketing studies to further assess its safety. Now a nonprofit consumer advocacy group says the FDA should remove the drug from the U.S. market after findings released this March show significant deadly heart risks. In a petition (PDF) sent to the FDA on […]

FDA seizing imported pharmaceuticals

FDA seizing imported pharmaceuticals

The FDA either destroys the intercepted drugs or returns them to the sender—which leaves people with legitimate drug orders up the creek. (Photo: Sharrett/Bloomberg) If you planned on saving money by ordering your prescriptions from Canada or somewhere else outside U.S. borders—or even if you’ve been doing that for some time—make sure you have a […]

Consumer group petitions FDA to yank a widely prescribed gout drug over heart risks

Consumer group petitions FDA to yank a widely prescribed gout drug over heart risks

A consumer advocacy group is asking regulators to “immediately remove” a widely used gout medication over concerns that it poses “unique, serious,” and potentially “fatal” risks to patients while not offering any health benefit. In a petition sent to the Food and Drug Administration on Thursday, Public Citizen argued there is “overwhelming evidence that the […]

1 2 3 50