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Human Drugs

Bipartisan Bill on Clinical Trial Participation

Representatives Raul Ruiz (D-CA) and Larry Bucshon (R-IN) introduce bipartisan legislation to improve participation in clinical trials by underreprese...

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Human Drugs

Complete Response on Liver Cancer Combo

FDA issues Elevar Therapeutics and its Chinese partner, Jiangsu Hengrui Pharmaceuticals, a complete response letter for their combination rivoceranib ...

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Human Drugs

SCANLY Home Optical Tomography Device Authorized

FDA grants Notal Vision a de novo authorization for its patient self-operated SCANLY Home optical coherence tomography device.

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Human Drugs

FDA Clears Implicity Heart Failure Algorithm

FDA clears an Implicity 510(k) for its algorithm SignalHF used in its remote monitoring for heart failure.

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Human Drugs

Brainomix Gets Clearance for AI e-Lung Tool

FDA clears a Brainomix 510(k) for its Brainomix 360 e-Lung for lung imaging.

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Federal Register

EUAs Revoked for 2 Covid Tests

Federal Register notice: FDA announces the revocation of the emergency use authorizations issued to Bio-Rad Laboratories for the Bio-Rad SARSCoV2 ddPC...

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Federal Register

Product-Specific ANDA Guidances Available

Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that provide recommendations on the design ...

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Federal Register

X4 Pharma Gets Priority Review Voucher

Federal Register notice: FDA announces the issuance of a priority review voucher to X4 Pharmaceuticals in response to gaining approval of a rare pedia...

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Medical Devices

FDA Qualifies New Ophthalmic Outcome Tool

FDA qualifies the Assessment of IntraOcular Lens Implant Symptoms patient-reported instrument as a medical device development tool.

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Human Drugs

Lilly Once-Weekly Insulin Meets Trial Endpoints

Lilly says its once-weekly insulin efsitora alfa met endpoints in two trials with insulin-nave adults with Type 2 diabetes.