FDAer Susan Rosencrance tells the agencys Generic Drug Forum that FDA has chosen nine applicants to participate in a Quality Maturity Management evalu...
Federal Register notice: FDA determines that UCBs Kemstro (baclofen) orally disintegrating tablets, 10 mg and 20 mg, were not withdrawn from sale for ...
Federal Register notice: FDA determines that Pfizers Vistaril (hydroxyzine pamoate) oral suspension, 25 mg/5 mL, was not withdrawn from sale for reaso...
Oncolytics Biotech asks FDA for a 2nd quarter Type C meeting to agree on the design and objectives for a registration-enabling trial of its pelareorep...
FDA releases the form FDA-483 with six observations from an inspection at the Cipla API and drug manufacturing facility in Ragaid, Maharashtra, India.
FDA grants breakthrough device designation to a Roche blood test intended to aid in a diagnosis of Alzheimers disease based on amyloid pathology.
FDA approves an AstraZeneca supplemental BLA for Fasenra (benralizumab) as an add-on maintenance treatment for patients with severe asthma aged 6 to 1...
FDA clears a Neurovalens 510(k) for the Modius Stress and its use to treat generalized anxiety disorder.
