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Dendreon submits a BLA supplement to increase the manufacturing capacity for Provenge (sipuleucel-T) at its Morris Plains, NJ manu...[ Price : $8.95]
FDA tells Bionovo that it supports the companys overall clinical development plan for Menerba to treat menopausal hot flashes.[ 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...[ 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....[ Price : $8.95]
AstraZeneca CEO David Brennan tells the Reuters Health Summit that significant cuts in taxpayer funding for FDA could mean slower ...[ Price : $8.95]
CDRH begins posting de novo classification letters to help medical device sponsors better understand how a device without a predic...[ Price : $8.95]
Federal Register Final rule: FDA classifies the tissue adhesive with adjunct wound closure device intended for total approximation...[ Price : $8.95]
Federal Register Final rule: FDA amends the animal drug regulations to reflect a sponsor name change from North American Nutrition...