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FDA Gives Breakthrough Status for AstraZenecas Tagrisso

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FDA grants AstraZeneca a breakthrough therapy designation for Tagrisso (osimertinib) for the first-line treatment of patients with...

FDA Awards 6 Research Grants on Natural History Studies

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FDA awards six new research grants ($6.3 million) for natural history studies in rare diseases that are intended to evaluate how t...

Animal Generic Drug User Fee Reauthorization Meeting

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Federal Register notice: FDA announces a 11/2 public meeting entitled Animal Generic Drug User Fee Act.

FDA Clears Game Ready Orthopedic Rehab Device

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FDA clears a Game Ready 510(k) for its orthopedic rehabilitation device, the Med4 Elite.

Animal Drug User Fee Reauthorization Public Meeting

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Federal Register notice: FDA announces a 11/2 public meeting entitled Animal Drug User Fee Act.

Regulatory Review Period Determined for Impella 2.5 System

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Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Abiomed Europes Impella 2.5...

Regulatory Review Period Determined for Bayers Kovaltry

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Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Bayers Kovaltry (antihemoph...

FDA Approves Flexion NDA for Knee Pain

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FDA approves a Flexion Therapeutics NDA for Zilretta (triamcinolone acetonide extended-release injectable suspension), an extended...

Sens. Warren, Grassley Call for Device Identifiers on Claims Forms

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Senators Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) call for medical device identifier information be added to Medicare cla...

FDA Approves Flexion NDA for Knee Pain

[ Price : $8.95]

FDA approves a Flexion Therapeutics NDA for Zilretta (triamcinolone acetonide extended-release injectable suspension), an extended...