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Vanda Pharmaceuticals files a lawsuit against FDA seeking an order to compel it to publish in the Federal Register a notice of opp...[ Price : $8.95]
FDA releases a form FDA-483 with three observations from an inspection at an Aurobindo active pharmaceutical ingredient manufactur...[ Price : $8.95]
FDA clears a Conformis 510(k) for its Acter Hip System to add a tri-taper femoral stem design to the device portfolio.[ Price : $8.95]
Medtronic recalls its Xomed NIM Contact Reinforced Electromyogram (EMG) Endotracheal Tube and the NIM Standard Reinforced EMG Endo...[ Price : $8.95]
FDA releases the FDA-483 citing 13 observations that were at the center of an Alvotech-received complete response letter on its bi...[ Price : $8.95]
FDA warns Texas Longhorn RXs Talon Pharmacy of Boerne, Boerne Texas, about selling adulterated compounded drug products.[ Price : $8.95]
FDA grants $2 million to Marker Therapeutics to support the treatment arm in a Phase 2 trial of its T-cell candidate to treat pati...[ Price : $8.95]
The Alliance for Pharmacy Compounding calls on FDA to reject recommendations in a National Academies report and instead maintain p...