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Boxed Warning Added to Incivek Label

[ Price : $8.95]

Vertex says a Boxed Warning has been added to the Incivek label to highlight the risk of fatal and non-fatal serious skin reaction...

Safety Board Backs Rockwell Iron Replacement Therapy

[ Price : $8.95]

Rockwell Medical says it has received backing from an independent Data Safety Monitoring Board providing oversight for the company...

NEWSROOM CLOSED FOR THE HOLIDAYS

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FDA Webview has closed its newsroom for the traditional Festive Season holiday break. We will resume normal operations on January ...

FDA Approves Angiotech Biopsy-sealing System

[ Price : $8.95]

FDA grants de novo approval for Angiotechs Bio-Seal Lung Biopsy Tract Plug System, a device that seals punctures left by lung biop...

FDA Sends Info on Emergency Use Authorization to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits to the Office of Management and Budget a proposed collection of information on reporting and ...

Execs, Not FDA, to Blame for Innovation Lag: Pundit

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Forbes commentator Bernard Munos says drug companies should fix their own problems with drug innovation rather than blaming FDA.

FDA Urged to Bar Generic Opioids that Can be Abused

[ Price : $8.95]

Former FDAer Scott Gottlieb and Sen. Tom Coburn call on FDA to quickly reject generic opioids that are not tamper-resistant.

Amarin Wants Chemport to be Vascepa API Supplier

[ Price : $8.95]

Amarin asks FDA to approve Chemport as an additional API supplier for its Vascepa.

FDA Accepts Roche MycoTOOL for Biological Product Test

[ Price : $8.95]

FDA accepts Roches MycoTOOL as the first commercially available mycoplasma test for release testing of a biopharmaceutical product...

ViroPharma Opens Phase 2b Study in Hereditary Angioedema

[ Price : $8.95]

ViroPharma Inc. initiates a Phase 2b study to evaluate the safety and efficacy of subcutaneous Cinryze in combination with Halozym...