From FDA approvals streamlining access to critical therapies to new breakthroughs in challenging malignancies, the field of cancer care continues to demonstrate remarkable progress.

Agency will require a Limitation of Use section in the prescribing information of all extended-release ADHD stimulants.

Opinion: Orrick's Irena Royzman and Dana Sublett write that judges have done a good job in multiple decisions that protect ...

Onward Medical announced today that it submitted its ARC-EX system for expanded FDA indication and for CE mark approval.

FDA Expands AbbVie's Mavyret Label To Include Acute Hepatitis C Treatment (CORRECTED) Vandana Singh Wed, Jun 11, 2025, 5:07 PM2 min read ...

The FDA is delaying implementation of a rule that would require food companies to print nutritional information on the front labels of their products. The proposed rule was developed by President ...

Now, the FDA has an opportunity to show that it’s serious about Americans’ health — by finalizing a rule that would require strong front-of-package nutrition labels across the food supply.

Amgen (NASDAQ: NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has granted an expanded label approval for Uplizna, now approved as a treatment for immunoglobulin G4-related ...

Exelixis, Inc. EXEL announced that the FDA has approved the label expansion of its lead drug Cabometyx (cabozantinib). The regulatory body approved Cabometyx for the treatment of adult and ...

The FDA approved an expanded label for Iluvien, which is now indicated for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye, according to a press release ...

FDA frequently provides updates on changes to drug labels, or when those labels have been deemed to be misleading. An example of the latter occurrence happened in December 2024, when the agency ...