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Gilead and Truvada Submit NDA for HIV Combo Pill

[ Price : $8.95]

Gilead Sciences files an NDA for a combination pill containing Truvada and Tibotec Pharmaceuticals investigational non-nucleoside ...

Vertex Completes Telaprevir NDA Submission

[ Price : $8.95]

Vertex says its telaprevir NDA submission is complete with results from three Phase 3 studies.

Gablofen Approved for Treating Spasticity

[ Price : $8.95]

FDA approves a CNS Therapeutics NDA for Gablofen (baclofen injection) for use in managing severe spasticity.

Quality System Violations Found at Eastern Cranial

[ Price : $8.95]

FDAs Baltimore District Office warns Eastern Cranial on Quality System and other violations associated with its KidCap Cranial Mol...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Eastern Cranial Affiliates, Eminent Spine, Fasprin Health/Nobel Laboratories, HS...

Comments Sought on Corrections & Removals

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Federal Register Notice: FDA seeks comments on Reports of Corrections and Removals 21 CFR Part 806.

Agenda Changed for Oncologic Drugs Panel Meeting

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Federal Register Notice: FDA amends the notice of a 12/2 meeting of the Oncologic Drugs Advisory Committee to postpone a discussio...

Appeals Court Rejects Vermont Doctor Information Law

[ Price : $8.95]

A federal appeals court rejects a Vermont law that tried to restrict health information company access to prescribing information.

FDA Says Hologic Selenia System Approvable

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FDA issues an approvable letter for Hologics Selenia Dimensions 3-D digital mammography system.

Heart Failure Test Cleared by FDA

[ Price : $8.95]

FDA clears a BG Medicine 510(k) for the Galectin-3 test for use in conjunction with clinical evaluation to help assess the prognos...