FDA approves expanded use of Sanofi's type 1 diabetes drug

June 12 (Reuters) - The U.S. Food and Drug Administration said on Friday it has approved the expanded use of Sanofi's type 1 ...

FDA Warns Alli—An Over-The-Counter Weight Loss Pill—Could Cause Fatal Kidney Problems

The nation’s only over-the-counter weight loss drug—which has been taken by millions—could cause fatal kidney problems.

Merck wins FDA label expansion for Welireg in kidney cancer

The U.S. Food and Drug Administration on Friday approved a label expansion for Merck’s (MRK) oral HIF-2α inhibitor belzutifan (Welireg) in combination with its anti-PD1 inhibitor Keytruda for renal ...
Becker's Hospital Review

FDA adds kidney injury warning to weight loss drug

FDA adds kidney injury warning to alli weight loss drug after reviewing 12 cases of kidney complications linked to orlistat use.
Healio

FDA updates Tremfya label to include joint damage inhibition in psoriatic arthritis

The FDA has approved a label expansion for the interleukin-23 inhibitor guselkumab to include the inhibition of structural ...
CNN

FDA delays when a final rule on what foods can be labeled as ‘healthy’ goes into effect

In December, the FDA finalized a rule that updates the nutritional requirements a human food item must meet to claim on its packaging that it is “healthy.” That rule was published with an effective ...
The American Journal of Managed Care

FDA Expands Upadacitinib Label for Treating Inflammatory Bowel Disease

Upadacitinib is now approved for IBD patients unsuitable for TNF blockers after one systemic therapy, broadening treatment options. Clinical trials show upadacitinib's efficacy in achieving remission ...
Regulatory Affairs Professionals Society

This Week at FDA: Upcoming Senate markup, first OTC CGM for children, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
RAPS

FDA drafts guidance on drug interaction labeling

The US Food and Drug Administration (FDA) has released a new draft guidance describing what should and should not be included in the Drug Interactions (DIs) section for human prescription drug and ...
The Hill

Tylenol maker: possible FDA label change ‘unsupported by scientific evidence’

Tylenol maker Kenvue is calling on the Food and Drug Administration (FDA) to back off a proposed safety label change to acetaminophen after the Trump administration linked its use during pregnancy to ...