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FDA Clears Crospon 510(k) for EsoFLIP Dilation Catheter

[ Price : $8.95]

FDA clears a Crospon 510(k) for its EsoFLIP balloon dilation catheter for procedures in the esophagus and colon.

FDA Clears Ranbaxy U.S. Manufacturing Facility

[ Price : $8.95]

FDA tells Ranbaxy that its U.S. generic drug subsidiary, Ohm Laboratories, has resolved GMP issues cited in a 12/2012 inspection o...

FDA Accepts Xolair sBLA for Chronic Idiopathic Urticaria

[ Price : $8.95]

FDA accepts a Genentech supplemental BLA for subcutaneous use of Xolair (omalizumab) in people with chronic idiopathic urticaria.

FDA Approves Sanofis OTC Nasacort Allergy Spray

[ Price : $8.95]

FDA approves a Sanofi NDA for an over-the-counter version of its Nasacort Allergy 24-hour nasal spray.

Companies Worrying About Woodcocks Successor

[ Price : $8.95]

A Reuters report says drug industry executives are concerned about who will succeed Janet Woodcock when she retires.

Pfizer Psoriasis Drug Meets 2 Trial Primary Endpoints

[ Price : $8.95]

Pfizer says two Phase 3 trials of its psoriasis drug tofacitinib met most of their primary endpoints.

Alkermes Gains Fast Track for Depression Drug

[ Price : $8.95]

FDA grants Alkermes fast track status for ALKS 5461 for the adjunctive treatment of major depressive disorder.

Sotera Wireless Patients Monitoring Technology Cleared

[ Price : $8.95]

FDA clears a Sotera Wireless 510(k) for its continuous non-invasive blood pressure technology, a new feature for the ViSi Mobile w...

FDA Clears Integra Laminoplasty System

[ Price : $8.95]

FDA clears an Integra LifeSciences 510(k) for the Integra Laminoplasty System.

Senator Urges Probe on FDA/Pharma Pay-to-Play Controversy

[ Price : $8.95]

U.S. Senator Joe Manchin (D-WV) tells FDA commissioner Margaret Hamburg that he will seek a full congressional investigation into ...