[ Price : $8.95]
FDAs Florida District Office warns Capillus about Quality System, Medical Device Reporting, and other violations in its manufactur...[ Price : $8.95]
Viiv Healthcare says it is submitting an NDA for a combination HIV-1 drug based on its Tivicay and two other antiretrovirals.[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Capillus, Dolphin Intertrade, Omid Nassam, R82 A/S. Dimitri Sirakoff, USP Labs, ...[ Price : $8.95]
FDA approves a Lupin supplemental NDA for Antara (fenofibrate) capsules in 30 mg and 90 mg strengths, indicated for treating patie...[ Price : $8.95]
Cubist Pharmaceuticals submits an NDA for its investigational antibiotic tedizolid phosphate, indicated for treating acute bacteri...[ Price : $8.95]
Durect Corp. says its development partner Pfizer will continue the development program for Remoxy (oxycodone) extended-release cap...[ Price : $8.95]
Stakeholders raise many questions and concerns about an FDA draft guidance on medical device reporting by manufacturers.[ Price : $8.95]
Curis Inc. and Debiopharma begin a Phase 1 study of Debio 0932, a heat shock protein 90 inhibitor in combination with everolimus i...