FiercePharma2h
FDA looks to clarify confirmatory trial mandate for accelerated approvals
In recent years, the FDA has amped up its supervision of accelerated approvals, including by requiring that confirmatory ...
The FDA’s Evolving Role in Public Health
A discussion of the development of consumer protection law in the US through the enactment of key legislation and formation ...
Stacker on MSN17d
Do you know what the first weight loss drug was? Here's a history of every kind, from the 1800s to Ozempic.
Humans have spent thousands of years experimenting with weight loss aids. While Ozempic and Wegovy may be generating ...
FDA issues another recall for oysters over norovirus risk
Restaurants in Washington and Oregon purchased these oysters and they could have been distributed to other states. “The FDA is awaiting further information on distribution of these oysters and will ...
FDA approves first medication for obstructive sleep apnea, which also promotes weight loss
The FDA approved a new drug treatment for obstructive sleep apnea that improves the condition through weight loss. Sleep ...
LAist on MSN16d
The FDA restricts a psychoactive mushroom used in some edibles
Hauser, the Colorado-based lawyer, sees this as a cautionary tale of the "hands-off" approach that the FDA has taken with ...
pharmaphorum6d
FDA makes history, approving Spark's eye gene therapy
But now the FDA has rubber-stamped the approval of Luxturna, the first ever gene therapy it has backed, all the attention is now on Spark, and what price it plans to charge for the therapy.
USA Today23d
FDA recalls more than 233,000 bottles of antidepressant over possible cancerous chemical
The U.S. Food and Drug Administration classified capsules of duloxetine, sold by New Jersey-based company Rising Pharmaceuticals, as a Class II risk on Dec. 5. The risk level is the FDA's second ...
CNN20d
FDA places its most serious warning on menopause drug due to risk of liver injury
The US Food and Drug Administration has placed its most serious warning – a so-called black-box warning – on a drug used to relieve menopausal hot flashes. The FDA says women who are taking ...
FDA Agrees On Accelerated Approval Pathway For AMT-130 In Huntington's Disease; Stock Up 89%
Gene therapy company uniQure N.V. (QURE) announced Tuesday that the company reached agreement with the U.S. Food and Drug ...