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Viiv Submitting HIV Drug NDA

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Viiv Healthcare says it is submitting an NDA for a combination HIV-1 drug based on its Tivicay and two other antiretrovirals.

Latest Warning Letters

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In its latest batch of Warning Letters, FDA cites Capillus, Dolphin Intertrade, Omid Nassam, R82 A/S. Dimitri Sirakoff, USP Labs, ...

FDA OKs New Dosage Strengths for Antara

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FDA approves a Lupin supplemental NDA for Antara (fenofibrate) capsules in 30 mg and 90 mg strengths, indicated for treating patie...

QS and MDR Violations Seen in Northern Digital Inspection

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FDA warns Northern Digital about Quality System and Medical Device Reporting violations in its manufacturing of reflective passive...

GPhA Says Biosimilars Need Same Name as Originals

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Generic drug manufacturers tell the World Health Organization that biosimilars should be given the same non-proprietary name as th...

FDA Reviewers Generally Positive on Simeprevir

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FDA medical reviewers says Janssens experimental hepatitis C drug simeprevir appears to be effective but has some side effects.

Cubist Files NDA for New Antibiotic

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Cubist Pharmaceuticals submits an NDA for its investigational antibiotic tedizolid phosphate, indicated for treating acute bacteri...

Pfizer Proceeding with Remoxy NDA After Meeting with FDA

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Durect Corp. says its development partner Pfizer will continue the development program for Remoxy (oxycodone) extended-release cap...

Stakeholders Have Many Concerns on Device Reporting Draft

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Stakeholders raise many questions and concerns about an FDA draft guidance on medical device reporting by manufacturers.

Curis, Debiopharm Start Phase 1 Study in Renal Cell Carcinoma

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Curis Inc. and Debiopharma begin a Phase 1 study of Debio 0932, a heat shock protein 90 inhibitor in combination with everolimus i...