Valisure files a lawsuit against the United States Pharmacopeia, accusing the standards-setting organization of making false and misleading statements...
FDA posts a draft revised guidance intended to help drug developers determine whether a proposed product should be submitted through the ANDA pathway ...
While Amgen continues its bid to prevent the withdrawal of Tavneos (avacopan) in the U.S., European regulators have recommended the revocation of the ...
Regeneron Pharmaceuticals stops a Phase 1/2a clinical trial of experimental anti-CD3 monoclonal antibody REGN7041 in patients with noninfectious uveit...
Sens. Ron Johnson (R-WI) and Rand Paul (R-KY) release a 2021 email from then-acting FDA commissioner Janet Woodcock in which she raised concerns about...
FDA plans a 9/9 meeting with the Reagan-Udall Foundation for the agency to hear public comments on perspectives involving opioid medication use.
Baxter is recalling (Class 1) certain lots of its Duo-Vent solution sets because the devices may allow air bubbles to enter the administration set dur...
FDA approves Lantheus Holdings Tauklarify (florquinitau F 18 injection) as a PET imaging agent to identify tau neurofibrillary tangle pathology in adu...
