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FDAer Susan Rosencrance tells the agencys Generic Drug Forum that FDA has chosen nine applicants to participate in a Quality Matur...[ Price : $8.95]
Federal Register notice: FDA determines that UCBs Kemstro (baclofen) orally disintegrating tablets, 10 mg and 20 mg, were not with...[ Price : $8.95]
Federal Register notice: FDA determines that Pfizers Vistaril (hydroxyzine pamoate) oral suspension, 25 mg/5 mL, was not withdrawn...[ Price : $8.95]
Oncolytics Biotech asks FDA for a 2nd quarter Type C meeting to agree on the design and objectives for a registration-enabling tri...[ Price : $8.95]
FDA releases the form FDA-483 with six observations from an inspection at the Cipla API and drug manufacturing facility in Ragaid,...[ Price : $8.95]
FDA grants breakthrough device designation to a Roche blood test intended to aid in a diagnosis of Alzheimers disease based on amy...[ Price : $8.95]
FDA approves an AstraZeneca supplemental BLA for Fasenra (benralizumab) as an add-on maintenance treatment for patients with sever...[ Price : $8.95]
FDA clears a Neurovalens 510(k) for the Modius Stress and its use to treat generalized anxiety disorder.