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Human Drugs

Keytruda Hits Endpoint in Cervical Cancer Trial

Mercks Keytruda with concurrent chemoradiotherapy meets the progression-free survival primary endpoint in an interim analysis of the KEYSTONE A-18 cer...

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Human Drugs

FDA Clears Xstrahl Skin Cancer Radiation Therapy

FDA clears an Xstrahl 510(k) for its Radiant Aura treatment device for providing radiation therapy to non-melanoma skin cancer patients.

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Human Drugs

FDA Grants Fast Track for Myelofibrosis Drug

FDA grants Karyopharm Therapeutics fast track status for selinexor for treating patients with myelofibrosis.

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Human Drugs

FDA Boosts Translational Sciences Achievements

The CDER Office of Translational Sciences 2022 annual report lists what it says were achievements in five areas of activity.

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Human Drugs

Legislators Hit FDA's India, China Inspections

Bipartisan leaders of the House Energy and Commerce Committee express concerns about FDA foreign inspections and ask for answers to 22 questions.

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Human Drugs

Akebia Resubmitting Kidney Disease NDA

Akebia Therapeutics completes an End of Dispute Type A meeting with FDA that discussed the companys upcoming NDA resubmission for vadadustat as a trea...

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Medical Devices

Medtronic Recalls Faulty Defibrillators

Medtronic recalls its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators with glassed feedthrough due to a p...

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Human Drugs

Olympus Recalls Bronchoscopes Over Laser Compatibility

Olympus recalls about 1,500 OES BronchoFiberscope BF Type devices after receiving complaints of endobronchial combustion during therapeutic laser proc...

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Human Drugs

Suggestions for Pediatric Drug Guidance

Four drug stakeholders suggest changes to a draft FDA guidance on scientific considerations in pediatric drug development.

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GAO Regenerative Medicine Policy Options

A Government Accountability Office report on the challenges of regenerative medicine therapies and technologies offers 11 policy options to be conside...