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Medical Devices

Medtronic Recalls Cobalt & Crome Defibrillators

Medtronic recalls its Cobalt and Crome implantable cardioverter defibrillators because the devices have the potential for reduced shock energy (about ...

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Medical Devices

Dyad Medical AI Echocardiogram App Cleared

FDA clears a Dyad Medical 510(k) for its echocardiogram application called Echo:Prio.

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Biologics

2 Children Die After Taking Novartis Gene Therapy

Weeks after being administered a Novartis gene therapy, two children die of acute liver failure, according to the company.

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Federal Register

Info Collection on Device Sterilization Agreements

Federal Register notice: FDA sends to OMB an information collection extension entitled Agreement for Shipment of Devices for Sterilization 21 CFR 801...

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Federal Register

9 ICH Vet Med Guidances Published

FDA posts nine guidances released by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal...

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Human Drugs

Roche Xofluza OK for Acute Uncomplicated Flu

FDA approves a Roche a supplemental NDA for Xofluza (baloxavir marboxil) for treating acute uncomplicated influenza in certain children.

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Medical Devices

4 Senators Urge Study on Pulse Oximeters

Citing lingering questions about pulse oximeters, four Senate Democrats urge FDA to initiate a post market study of the devices.

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Biologics

Daiichi Sankyo Enhertu Approved for Lung Cancer

FDA grants Daiichi Sankyo accelerated approval for Enhertu for treating adult patients with unresectable or metastatic non-small cell lung cancer.

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Human Drugs

Suit Questions FDA Patent Certification Authority

Attorney Sara Koblitz says an Avadel suit against FDA challenges the agency's authority to list some patents in the Orange Book and require certificat...

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Human Drugs

MaaT013 Clinical Hold Still in Place

FDA says its clinical hold on a MaaT Pharma Phase 3 trial of an investigational graft-versus-host disease drug remains in place while the company prov...