Sanofi SNY has announced that the FDA has granted a fast-track designation to its one-time intravitreal gene therapy, SAR446597, for the treatment of geographic atrophy (GA) due to age-related macular ...

The FDA has cleared the Hilo Band (G0 Blood Pressure Monitoring System) for at-home blood pressure monitoring in adults.

Earlier, in January 2025, the FDA released a companion piece of draft guidance titled “Considerations for the Use of ...

Under the updated regulations, exemptions that previously allowed import of some product shipments valued at $800 or less ...

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 ...

Pembrolizumab, an immune checkpoint inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with resectable locally advanced head and neck ...