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Aurora Spine SiLO Sacroiliac Device Cleared

[ Price : $8.95]

FDA clears an Aurora Spine 510(k) for its SiLO TFX MIS Sacroiliac Joint Fixation System.

Rx Drug User Fee Rates Set

[ Price : $8.95]

Federal Register notice: FDA sets the rates for prescription drug user fees for fiscal year 2023.

FDA Needs More Postmarket Commitment Authority: Study

[ Price : $8.95]

Researchers say Congress should consider giving FDA more authority to deal with companies that dont complete their postmarket comm...

2 Final Post-Approval Activity Guidances

[ Price : $8.95]

FDA publishes two final guidances to facilitate the timely start and finish of medical device post-approval studies and postmarket...

Roches Pathway Test OKd for Low HER2

[ Price : $8.95]

FDA approves a Roche PMA for the Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to identify metastatic breast canc...

Revatio sNDA for Pulmonary Hypertension Heads to Panel

[ Price : $8.95]

Federal Register notice: FDA announces a 12/14 Cardiovascular and Renal Drugs Advisory Committee meeting to discuss a Viatris Spec...

Panel to Discuss Heart Failure Drug

[ Price : $8.95]

Federal Register notice: FDA announces a 12/13 Cardiovascular and Renal Drugs Advisory Committee meeting to review a Cytokinetics ...

IR, DRL Guidance

[ Price : $8.95]

FDA publishes a guidance with updated GDUFA 3 information on information requests and discipline review letters.

Competitive Generic Therapies Guidance

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FDA publishes a guidance with information on competitive generic therapies.

Glaxo Lung Cancer Phase 2 Trial Meets Endpoint

[ Price : $8.95]

GlaxoSmithKline announces positive results from the Phase 2 PERLA trial of its lung cancer drug Jemperli.