FDA publishes the latest CDER guidance agenda showing plans for 85 new or revised guidances to be issued in 2026.
FDA approves Merck's Lipfendra (enlicitide) 20 mg tablets as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol in certain ...
Kalshi launches a pilot program allowing traders to buy and sell contracts tied to the outcomes of late-stage clinical trials and FDA regulatory decis...
FDA releases the form FDA-483 with 13 observations from an April inspection at Chinas Zhejiang Hushai Pharmaceutical Co.
The American Society of Health System Pharmacists says there were 227 active drug shortages in the second quarter of 2026, trending up for the third q...
Rep. Diana DeGette (D-CO) wins FDA assurances that several policy announcements issued during former commissioner Marty Makary's tenure including art...
FDA warns Irvine, CA-based Nihon Kohden Digital Health Solutions that it is marketing an adulterated and misbranded unapproved medical device.
Witnesses at a House Energy and Commerce Health Subcommittee hearing urge lawmakers to modernize the nation's clinical trial system, and strengthen FD...
