The expedited approval of mpox vaccines is critical to addressing this public health emergency. Building on the practice in approving COVID-19 vaccines, this analysis investigates the regulatory ...

The U.S. Food & Drug Administration has issued an urgent medical device correction for certain insulin pumps manufactured by ...

The Food and Drug Administration (FDA) is considering placing a black-box warning on antidepressant use in pregnancy, ...

Presented positive results from the phase 3 randomized, placebo-controlled clinical trial of CAN-2409 (aglatimagene ...

Gained alignment with U.S. Food and Drug Administration (FDA) on the ongoing Phase 2 AQUAx2 randomized double-blind, placebo-controlled pivotal study in Grade 2/3 radiation-induced xerostomia (RIX) to ...

The company’s new Whoop MG is the subject of a disagreement with the US Food and Drug Administration (FDA) over whether it's ...

New resources include examples of traceability plans for food processors, distribution centers and aquaculture farms and ...

Beam Therapeutics' said the Food and Drug Administration granted generative medicine advanced therapy designation to its sickle cell disease treatment BEAM-101.

The nationwide shortage of sodium chloride 0.9% intravenous (IV) saline has officially ended, according to the U.S. Food and ...

Wearable technology sits in a grey area when it comes to regulation. Whoop says the software tool doesn't meet the definition ...

Europe, Ukraine hope for chilly Putin summit ▪ The Hill interview: Newsom defends redistricting fight ▪ Progressives take center stage in mayoral contests ▪ Israel steps up ...

Florida Attorney General James Uthmeier held a press conference in Tampa on Wednesday afternoon to discuss "7-hydroxymitragynine" – often called "7-OH." The event comes weeks after the U.S. Food and ...