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, ...

The approval of ArteraAI Prostate by the FDA as a software as a medical device (SaMD) means it can now be used at the point ...

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 ...

PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on unlocking the pharmaceutical potential of ketamine, announced today ...

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 move would add another barrier for parents who want to vaccinate healthy children ahead of the respiratory virus season.