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Stomach Bleeding Warning Added to 3 Cold Meds

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FDA approves labeling changes for 24 drugs, including stomach bleeding Warnings for three OTC cold products.

ISTA Moves to Phase 3 with ''Dry Eye'' Drug

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ISTA Pharmaceuticals starts a Phase 3 clinical trial involving Remura (bromfenac ophthalmic solution) for alleviating dry eye dise...

Tobacco Panel to Discuss Menthol Cigarettes Impact

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Federal Register Notice: FDAs Tobacco Products Scientific Advisory Committee will meet 10/7 on industry documents on the use of me...

Reviewers Back Higher Pradaxa Dose

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FDA asks its Cardiovascular and Renal Drugs Advisory Committee to comment on the safety, effectiveness, and risk/benefit of Boehri...

FDA, CMS Considering Parallel Review Process

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FDA and CMS are soliciting comments on a proposal for voluntary parallel review of innovative medical products as a way of speedin...

Grant for Study on Alpha 1 Antitrypsin Deficiency Therapy

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Applied Genetic Technologies wins a $1 million grant from FDA' orphan products program to fund a Phase 2 clinical trial intended t...

Panels to Discuss I.V. Anti-Seizure Drugs

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Federal Register Notice: FDAs Peripheral and Central Nervous System Drugs and the Drug Safety and Risk Management Advisory Committ...

FDA Clears Integra Line of Rongeurs

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FDA clears an Integra LifeSciences Holdings 510(k) for its new line of extended length and detachable Ruggles Kerrison rongeurs, i...

FDA Approves Savient Gout Drug

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FDA approves a Savient BLA for Krystexxa (pegloticase), indicated for treating gout in adults who do not respond to or tolerate co...

FDA Extends Review of AstraZeneca's Blood Thinner

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FDA extends by three months its review of an AstraZeneca NDA for blood thinner Brilinta (ticagrelor).