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Allergan Pays $750 Million on Namenda Switch Scheme

[ Price : $8.95]

Allergan and its Forest Laboratories subsidiaries agree to pay $750 million to settle a lawsuit brought by direct purchasers of Al...

Orthopedic Surgical Instruments Put Into Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies orthopedic surgical instrumentation designed for osteochondral implants with press-fit fix...

Draft Guide on Homeopathic Drug Products

[ Price : $8.95]

Federal Register notice: FDA makes available a revised draft guidance entitled Drug Products Labeled as Homeopathic.

Allergan NDA Lo Minastrin FE Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws the NDA approval of Allergan Pharmaceuticals Lo Minastrin FE because it is no longer market...

Internal Therapeutic Massagers Put Into Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies internal therapeutic massagers into Class 2 (special controls).

FDAs Growing Concern on Device Sterilization

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FDA grows concerned over recent closures of certain large-scale sterilization facilities that use ethylene oxide to sterilize medi...

Impella Heart Pump Study Confirms Survival Data

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Abiomed says that a post-approval study confirmed survival data in its pre-approval study for the Impella RP heart pump.

Five Class 2 Devices Exempt from 510(k)

[ Price : $8.95]

Federal Register notice: FDA announces its decision to exempt a list of Class 2 devices from premarket notification requirements.

Melintas Baxdela Expanded Approval for Pneumonia

[ Price : $8.95]

FDA approves a Melinta Therapeutics supplemental NDA for Baxdela (delafloxacin) for treating adult patients with community-acquire...

NuCana Phase 3 Bilary Tract Cancer Study

[ Price : $8.95]

FDA authorizes NuCana to begin a Phase 3 study (nutide:121) of the investigational drug Acelarin in combination with cisplatin for...