As the threat of counterfeiting continues to torment industry stakeholders and patients, more strategic approaches to ...

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

The FDA is revising the labeling of all extended-release ADHD medications to warn about adverse reactions in patients younger ...

Pharma: Reform of the EU Pharmaceutical Legislation; German Medical Research Act enacted fostering R&D also including confidentiality of drug ...

Boston Scientific has received expanded FDA approval for the use of its Watchman FLX and Watchman FLX Pro devices.

The FDA revises ADHD stimulant labels to warn of weight loss risk. Warnings target children under 6, noting higher adverse reaction rates. Stimulants, like Ritalin, increase dopamine and ...

The U.S. Food and Drug Administration said on Monday it is revising the labeling of all extended-release stimulants used to treat attention-deficit hyperactivity disorder to include warnings about ...

Label updates have been approved by the FDA for the CAR T-cell therapies Breyanzi and Abecma in large B cell lymphoma and multiple myeloma, respectively.

FDA approves AbbVie's Mavyret for acute hepatitis C, expanding its use to patients 3 and older with or without cirrhosis after positive trial data.

These warning labels are part of a proposed FDA plan to put simple, easy-to-see nutrition information right on the front of packaged foods.

The FDA has told vaccine manufacturers to expand the warning labels on their COVID-19 shots with more information about the risk for rare heart conditions following vaccination.

Health and Human Services Secretary Robert F. Kennedy Jr. said Wednesday the Food and Drug Administration should change the label on abortion drug mifepristone and conduct a top-to-bottom review ...