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Changes Sought in FDA Diabetes Endpoint Guidance

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Three stakeholders make suggestions to an FDA draft guidance on efficacy endpoints in clinical trials for antidiabetic drugs.

Lillys Retevmo Hits Phase 3 Trial PFS Endpoint

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Lilly says its Retevmo met the primary progression-free survival endpoint in a clinical trial in patients with RET-mutant medullar...

Welldoc Insulin Dose Calculator Clearance

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FDA clears a Welldoc 510(k) for its BlueStar diabetes digital health device that provides bolus insulin dose recommendations based...

FDA Orphan Status for Multiple Myeloma Therapy

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FDA grants Nexcella an orphan drug designation for its CAR-T cell therapy NXC-201 for treating multiple myeloma.

Objectionable Conditions in Clinical Investigation

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FDA warns Angela Stupi in Cranberry Twp., PA, about violations in her conduct of two trials with investigational drugs.

FDA Warns Walmart, Amazon on Molluscum Drugs

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FDA warns Walmart and Amazon they are illegally distributing unapproved new drugs to treat molluscum contagiosum.

Ambu Illegally Selling Airway Device: FDA

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FDA warns Noblesville, IN-based Ambu, Inc., that it is illegally distributing an unapproved medical device.

Clinical Hold Lifted on Sickle Cell Drug

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FDA lifts a clinical hold against a Fulcrum Therapeutics IND for FTX-6058 for the potential treatment of sickle-cell disease.

More ANDA Bioequivalence Draft Guides Posted

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Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for generic drug develo...

Require Generic Ozobax Safety Data: Metacel

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Metacel says FDA must require sponsors of generic Ozobax to perform and submit the same flavoring safety data that Metacel was req...