Earlier, in January 2025, the FDA released a companion piece of draft guidance titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and ...

The U.S. Food and Drug Administration said on Tuesday it will now review all imports of the products it regulates regardless of their quantity or value, after a federal law enforcement agency recently ...

Medtech company Wenzel Spine received FDA clearance for panaSIa, an expandable sacroiliac fusion implant.  The implant offers a minimally invasive procedure option for patients with sacroiliac joint ...

Intuitive Surgical Inc. (NASDAQ:ISRG) is one of Goldman Sachs’ top healthcare stock picks. On July 10, the company secured ...

TAVIPILOT Soft is said to be a ‘world-first’ provision for real-time surgical guidance during TAVI and TAVR procedures.

Novo Nordisk announces collaboration with WeightWatchers to offer patients living with obesity access to FDA-approved Wegovy® through NovoCare® PharmacyRo and LifeMD collaborations continue ...

FDA approves Dupixent for treating bullous pemphigoid in adults, showing significant improvements in disease management.

The FDA expanded the approval of Moderna’s RSV vaccine, extending the license to include more adults and giving the company a welcome win.

Researchers from the George Washington University have uncovered promising evidence in an animal study that shows setmelanotide, an FDA-approved medication for a rare genetic obesity disorder, may ...

Veristat, a leading global clinical research organization (CRO) and consultancy, proudly congratulates George Medicines on the U.S. Food and Drug Administrat ...

KalVista has become the latest biotech to face delays to FDA decision-making, as the agency blames a “heavy workload” for pushing back a PDUFA date.

The Food and Drug Administration (FDA) expanded the approval of Moderna’s RSV vaccine late Thursday to include people 18 to 59 years old who are at increased risk for severe illness from ...