The U.S. Food and Drug Administration said on Monday it is revising the labeling of all extended-release stimulants used to ...

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

FDA updates CAR T-cell therapy labels, easing monitoring requirements and expanding access for eligible patients in oncology.

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

The U.S. Food and Drug Administration said on Friday it had eliminated risk evaluation and mitigation strategies (REMS), a ...

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

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

The FDA has accepted Aquestive Therapeutics’ new drug application for its Anaphylm sublingual epinephrine film for treating ...

Bristol-Myers Squibb has claimed FDA approval for a new, tumour-agnostic indication for Augtyro, the cancer drug it acquired as part of its $4.1 billion takeover of Turning Point Therapeutics in 2022.

One lot of reflux medicine got recalled when fluid retention tablets were discovered in the medicine bottles.

In this fireside chat webinar, experts break down the FDA's new PDURS framework for adding software to drug labels. Learn how it impacts pharma and what you need to know. Join us on Tuesday 9th ...

The Prescription Drug User Fee Act typically calls for a period of 10 months for the FDA to review such applications, although drugs that are deemed a priority have a review period of six months.