An updated Class 1 recall notice says Hamilton Medical is recommending that certain coaxial breathing circuit sets used with HAMILTON-C1, HAMILTON T-1...
FDA accepts for priority review a Belite Bio NDA for tinlarebant for treating Stargardt Disease Type 1.
A petition submitted to FDA calls for the agency to create conditional nonprescription access to albuterol sulfate inhalers.
The Justice Department says it has reached a deferred prosecution agreement with Veloxis Pharmaceuticals under which the company is paying $46 million...
Aquestive Therapeutics says that based on new human factor and pharmacokinetic trials of its Anophylm sought by FDA in a complete response letter, it ...
FDA releases the Form FDA-483 with three observations from a 2024 inspection at Indias MSN Life Sciences Unit II active pharmaceutical ingredient manu...
Resilient Pharmaceuticals resubmits an NDA for its midomafetamine capsules for a proposed indication of treating post-traumatic stress disorder.
President Trump signs an executive order directing the federal government to develop what the White House calls "Gold Standard Childhood Vaccine Recom...
