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Dendreon BLA Supplement for Increased Provenge Manufacturing

[ Price : $8.95]

Dendreon submits a BLA supplement to increase the manufacturing capacity for Provenge (sipuleucel-T) at its Morris Plains, NJ manu...

FDA Backs Menerba Clinical Development Plan

[ Price : $8.95]

FDA tells Bionovo that it supports the companys overall clinical development plan for Menerba to treat menopausal hot flashes.

Court Rejects Actavis Vyvanse Appeal

[ Price : $8.95]

A DC Appeals Court ruling dismisses an Actavis claim that FDA should not enforce five years of marketing exclusivity for Shires Vy...

Trial in U.S. Begins with New Antibiotic Class

[ Price : $8.95]

FDA approves a PolyMedix IND for PMX-30063, a synthetic defensin-mimetic antibiotic to initiate a Phase 1 clinical trial in the U....

Industry Fears FDA Budget Cuts: Zeneca CEO

[ Price : $8.95]

AstraZeneca CEO David Brennan tells the Reuters Health Summit that significant cuts in taxpayer funding for FDA could mean slower ...

CDRH Pilot Posting of De Novo Letter

[ Price : $8.95]

CDRH begins posting de novo classification letters to help medical device sponsors better understand how a device without a predic...

FDA Classifies Tissue Adhesive into Class 2

[ Price : $8.95]

Federal Register Final rule: FDA classifies the tissue adhesive with adjunct wound closure device intended for total approximation...

Animal Drug Sponsor Name Changed

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Federal Register Final rule: FDA amends the animal drug regulations to reflect a sponsor name change from North American Nutrition...

Comments Extended on PDUFA Reauthorization Meeting

[ Price : $8.95]

Federal Register Notice: FDA reopens the comment period on a public meeting soliciting input on reauthorization of PDUFA.

FDA Approves Egrifta for Lipodystrophy in HIV Patients

[ Price : $8.95]

FDA announces its approval of Montreal-based Theratechnologies tesamorelin, Egrifta, to treat lipodystrophy in HIV patients.