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FDA Approves Combivent Respimat with New Inhaler

[ Price : $8.95]

FDA approves a Boehringer Ingelheim Pharmaceuticals NDA for Combivent Respimat (ipratropium bromide and albuterol), a new propella...

Court Grants Restraining Order on Generic Lovenox

[ Price : $8.95]

Massachusetts federal court grants a temporary restraining order to prevent Watson Pharmaceuticals and Amphastar from marketing Am...

FDA 'Fast Track' for DARA Pain Drug

[ Price : $8.95]

FDA grants a fast track designation for DARA BioSciences' KRN5500 for treating neuropathic pain in patients with cancer.

FDA Approves Onco's Generic Cladribine

[ Price : $8.95]

FDA approves an Onco Therapies ANDA for a generic copy of Janssen's Luestatin.

FDA Says AlloStem Product Needs BLA

[ Price : $8.95]

FDA says AlloSource needs to submit a BLA for its AlloStem cell-scaffold product, which is intended to be used as a bone graft.

FDA Proposes User Fees for Device Reviewer Bonuses

[ Price : $8.95]

FDA proposes using user fee money to award retention bonuses to CDRH device reviewers to help improve consistency with device revi...

Pfizer Sues Watson Labs to Block Generic Embeda

[ Price : $8.95]

Pfizer sues Watson Laboratories over an ANDA seeking approval to market a generic copy of King Pharmaceuticals' Embeda.

Panel to Discuss Contura PMA for Facial Wrinkles

[ Price : $8.95]

Federal Register Notice: FDAs General and Plastic Surgery Devices Panel will meet 12/1 to vote on a Contura, Inc. PMA for Aquamaid...

BioCurex Requests pre-IDE Talks with FDA on RECAF Prostate Test

[ Price : $8.95]

BioCurex submits information and requests a pre-Investigational Device Exemption meeting with FDA to discuss its RECAF test for us...

Venture Capital Survey Cites FDA as Driving Away Investment

[ Price : $8.95]

A survey of more than 150 venture capital firms finds them decreasing investments in U.S. biopharmaceutical and medical device com...