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Medical Devices

Alert on Respironics Airway Pressure Devices

FDA posts a safety alert about Philips Respironics recalling certain bi-level positive airway pressure machines that may contain a plastic contaminate...

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Biologics

Erytech Scraps Plans for Leukemia BLA

Erytech Pharma says it is no longer planning to submit a BLA for Graspa in hypersensitive acute lymphoblastic leukemia following FDA feedback that req...

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Human Drugs

Farxiga Phase 3 Data Show Mortality Benefit

New Phase 3 data on AstraZeneca's Farxiga (dapagliflozin) demonstrate a mortality benefit compared to placebo in patients with heart failure.

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Medical Devices

Intera Oncology Recalls Hepatic Artery Pump

Intera Oncology recalls its Intera 3000 Hepatic Artery Infusion Pump due to complaints the device was delivering medications faster than expected.

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Federal Register

Guide on Evaluation of QT/QTc Interval Prolongation

Federal Register notice: FDA makes available a final guidance for industry entitled E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval...

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Federal Register

Draft Guide on Pediatric Extrapolation

Federal Register notice: FDA makes available a draft guidance entitled E11A Pediatric Extrapolation.

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Federal Register

Drug Interaction Studies Draft Guide

Federal Register notice: FDA makes available a draft guidance entitled M12 Drug Interaction Studies.

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Federal Register

Info Collection on User Fee Review Transparency

Federal Register notice: FDA sends to OMB an information collection revision entitled Review Transparency and Communication for New Molecular Entity N...

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Federal Register

FDA Issues EUA for Covid Test, Revokes 4 Others

Federal Register notice: FDA announces the issuance of one, and revocation of four Emergency Use Authorizations issued to STS Lab Holdco (a subsidiary...

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Biologics

Moderna Files Patent Suit Against Pfizer/BioNTech

Moderna files a patent infringement lawsuit against Pfizer/BioNTech in Massachusetts federal court over their Comirnaty Covid-19 vaccine.