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Amneal Refiles NDA for Parkinsons Drug

[ Price : $8.95]

Amneal Pharmaceuticals resubmits an NDA for IPX203, a novel oral formulation of carbidopa/levodopa extended-release capsules for t...

Prepare Now for QMSR Transition: Attorneys

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Four Hogan Lovells attorneys say medical device companies should begin now to prepare for the implementation of FDAs new Quality M...

Complex Generic/Hybrid Drugs Pilot Expands

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Office of Generic Drugs associate director of stakeholder and global engagement Sarah Ibrahim says FDA and EMA are evaluating a ne...

Gilead Nixes Leukemia Phase 3 Trial

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Gilead Sciences discontinues its Phase 3 ENHANCE-3 study of magrolimab in acute myeloid leukemia (AML) after FDA placed a clinical...

6 Info Collections Approved by OMB

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Federal Register notice: FDA posts a listing of six information collections that have been approved by OMB.

GSK Wins Priority Review for Expanded Use of RSV Vaccine

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FDA accepts for priority review a GSK supplemental BLA to extend the indication of its Arexvy adjuvanted respiratory syncytial vir...

Califf on How FDA Addresses Chronic Diseases

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FDA commissioner Robert Califf and two of his top associates describe how the agency uses its role to help address common chronic ...

Bipartisan Animal Testing Reform Bill

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Bipartisan members of the House introduce legislation to require FDA to produce a final rule to implement animal testing reforms a...

Breakthrough Designation for Back Pain Gel

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FDA grants Orthoson a breakthrough device designation for its Bio-Structural Gel and its use to reduce back pain caused by degener...

Amgen Seeks Expanded Blincyto Indication

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FDA accepts for priority review an Amgen supplemental BLA for Blincyto (blinatumomab) for treating early-stage, CD19-positive B-ce...