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Ways to Address GSI Shortages: Report

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Two Brookings Institution fellows suggest three steps to address the shortage of generic sterile injectable drugs.

Blincyto Get FDA Full Approval

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FDA grants full approval to Amgens previously accelerated-approved BLA for Blincyto (blinatumomab) for treating certain adults and...

FDA Cancer Biomarker Pilot

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FDA launches a pilot program to post laboratory-developed test performance information using biomarkers to help facilitate better ...

Complete Response on F2G Antifungal NDA

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FDA issues F2G Ltd. a complete response letter on its NDA for olorofim, an antifungal for invasive fungal infections in patients w...

Multiple Violations at Vitang Technology

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FDA warns Tustin, CA-based Vitang Technology that its UniSmile Dental Aligner is misbranded and adulterated and thus is being sold...

Arcellx CAR-T Therapy on Clinical Hold

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FDA issues a clinical hold on Arcellxs CART-ddBCMA for treating patients with relapsed or refractory multiple myeloma, after a rec...

Panel to Vote on 2 Hypertension Devices

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Federal Register notice: FDA announces an 8/22-23 advisory committee meeting to review a ReCor PMA and a Medtronic PMA for their d...

Professor Calls for Alzheimers Drugs REMS

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University of Pennsylvania medical school professor Jason Karlawish makes the case for FDA to require a detailed REMS for new Alzh...

FDA Grants, Denies BI Spiriva Petition

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FDA explains its reasoning for granting in part and denying in part a Boehringer Ingelheim 2012 petition concerning its Spiriva Ha...

New Areas of ICH Harmonization

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The International Council for Harmonization Assembly approves the addition of three new topics for harmonization.