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FDA Approves Armpit Testosterone Replacement

[ Price : $8.95]

FDA approves an Eli Lilly and Acrux NDA for Axiron (testosterone) topical solution applied to the armpit for replacement therapy i...

Genzyme Says it Makes Milestone Progress on Consent Decree

[ Price : $8.95]

Genzyme says it has met the first milestone under its consent decree with FDA over GMP issues at its Allston, MA manufacturing fac...

FDA Posts Inspection Findings on Gilead California Plant

[ Price : $8.95]

FDA field investigators cite aseptic processing deficiencies at a Gilead San Dimas, CA manufacturing plant.

Micromedics Recalls 3 Devices Over Sterility

[ Price : $8.95]

Micromedics recalls its Surgical Sealant Dispensers, Nasal Septal Buttons, and Otological Ventilation Tubes because the products a...

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

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

Quality System Violations Found at Eastern Cranial

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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.