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Fast Track for Phanes Lung Cancer Drug

[ Price : $8.95]

FDA grants Phanes Therapeutics a fast track designation for PT217 and its use in treating patients with extensive-stage small cell...

No Benefit in Many Cancer Accelerated Approvals

[ Price : $8.95]

Harvard Medical School researchers say fewer than half of the cancer drugs given accelerated approval between 2013 and 2023 demons...

Susceptibility Test Interpretive Criteria Updates

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Federal Register notice: FDA makes available its annual compilation of update notices to the agencys Susceptibility Test Interpret...

BrainStorm Gets FDA Buy-In on Special Protocol

[ Price : $8.95]

FDA issues a written agreement with BrainStorm Cell Therapeutics under a Special Protocol Assessment on the design of the companys...

Antaria API Deviations Cited

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FDA warns Australias Antaria Pty. Ltd. about CGMP deviations in its production of active pharmaceutical ingredients.

Vanda Case Could Produce Legislation: Report

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A Congressional Research Service paper points to possible legislation Congress may want to consider to clarify how FDA is to use c...

10 FDA Advisors Had Financial Ties with Abbott: KFF

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A KFF Health News report carried online by NBC says 10 members of an FDA advisory committee evaluating an Abbott cardiac device ha...

Methodological Rigor Info May Help Promotions: OPDP

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CDER Office of Prescription Drug Promotion researchers say disclosing methodological rigor in communications to healthcare provide...

Alkem Labs Hit With 10-item Form-483

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An FDA inspection last month at Alkem Laboratories India manufacturing facility leads to a 10-observation Form FDA-483.

Philips Respironics Consent Decree Approved

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A federal court approves an FDA-brokered consent decree against Philips Respironics over its defective breathing devices.