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Advisors Unimpressed by BioMarin Duchenne Trial

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Members of the FDA Peripheral and Central Nervous System Drugs Advisory Committee vote 15-2 that lack of efficacy in a BioMarin Ph...

Lyrica Trial Misses Endpoint

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Pfizer says that a Phase 3 trial of its Lyrica to treat adults with chronic post-traumatic peripheral neuropathic pain did not mee...

FDA Clears EDDA Tech 3D Surgical System

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FDA clears an EDDA Technology 510(k) for the IQQA Guide system, a device that supports intra-operative precision 3D navigation for...

Tylenol with Codeine Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Tylenol with Codeine in different strengths was not withdrawn from sale for reasons o...

Meeting on Patient-Focused Psoriasis Drug Development

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Federal Register Notice: FDA plans a public meeting 3/17/16 on Patient-Focused Drug Development for Psoriasis.

3 New Biologics Act Cases Poised to Move Forward

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A Goodwin Procter post says there are three cases pending in federal courts that will shed further light on Biologics Price Compet...

FDA Clears Theralase Therapeutic Laser

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FDA clears a Theralase Technologies 510(k) for its next generation therapeutic laser, the TLC-2000 Therapeutic Medical Laser Syste...

Fast Track Given to Cellceutix Brilacidin-OM

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FDA grants Cellceutix a Fast Track Designation for Brilacidin-OM, an oral rinse formulation of the companys defensin-mimetic Brila...

Novartiss Fluad 1st Vaccine Approved with Adjuvant

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FDA approves a Novartis Vaccines and Diagnostics BLA for Fluad, the first seasonal influenza vaccine containing an adjuvant.

Allow Importation of Some Canadian Drugs: Senators

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Sens. Grassley and McCain say that HHS should certify importation of prescription drugs from Canada when certain conditions are me...