FDA releases the Form FDA-483 with three observations from a 2024 inspection at Indias MSN Life Sciences Unit II active pharmaceutical ingredient manu...
The Justice Department says it has reached a deferred prosecution agreement with Veloxis Pharmaceuticals under which the company is paying $46 million...
A petition submitted to FDA calls for the agency to create conditional nonprescription access to albuterol sulfate inhalers.
Aquestive Therapeutics says that based on new human factor and pharmacokinetic trials of its Anophylm sought by FDA in a complete response letter, it ...
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.
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...
