Amid recent backlash stemming from market withdrawals and trial delays, the FDA seeks to further clarify its requirements for ...

Breakthrough Therapy Designation granted based on key positive data from the Phase 2b (RIZE) study and current unmet medical need in congenital ...

The FDA has set maximum levels for lead in packaged processed foods sold in jars, pouches, tubs or boxes. Here's what to know.

A systematic review of randomized controlled trials (RCTs) assessed the efficacy and safety of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and co-agonists for obesity in adults without ...

You don't need a prescription to purchase a test that will tell you whether you're sick with COVID or the flu.

The Food and Drug Administration has set maximum levels for lead in baby foods like jarred fruits and vegetables, yogurts and ...

The Food and Drug Administration on Monday proposed a long-awaited plan aimed at improving how pulse oximeters work on people ...

The U.S. health regulator on Monday proposed new guidelines for widely-used blood oxygen monitoring devices to improve their ...

Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should either ...

Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released ...

After nabbing an FDA approval last summer for its T-cell lymphoma treatment Lymphir, Citius Oncology is eyeing strategic ...

Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025Cyprium is eligible to receive royalties and up to $129 ...