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Comments Sought on Tobacco-Derived Products

[ Price : $8.95]

Federal Register Notice: FDA reopens the comment period on products made or derived from tobacco that will be subject to regulatio...

Boston Scientific Class 1 Recall of Rotawire Guidewire

[ Price : $8.95]

Boston Scientific begins a Class 1 recall of its RotaWire Elite Guidewire and wireClip Torquer Guidewire components because they m...

Janssen Files BLA for Stelara in Crohns Disease

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Janssen Biotech and Janssen-Cilag file a BLA seeking approval for Stelara (ustekinumab) for treating adult patients with moderate ...

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.

Beiersdorf Wants Nivea Drug Petition Denied

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Beiersdorf says FDA should deny a petition asking for enforcement action against the company for marketing a Nivea lotion as a cos...

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...