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Daiichi Sankyo Enhertu Approved for Lung Cancer

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

Suit Questions FDA Patent Certification Authority

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

MaaT013 Clinical Hold Still in Place

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

Info Collection on Mammography Quality Standards

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Federal Register notice: FDA seeks comments on an information collection extension entitled "Mammography Quality Standards Act Req...

Info Collection on Environmental Impact Considerations

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Federal Register notice: FDA sends to OMB an information collection revision entitled: "Environmental Impact Considerations."

Medical Device Accessories Information Collection

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Federal Register notice: FDA sends to OMB an information collection extension entitled "Medical Device Accessories."

BD Intraosseous Devices Class 1 Recall

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FDA says the Becton Dickinson recall of three intraosseous medical devices is Class 1.

Menarini/Radius Submit Breast Cancer NDA

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The Menarini Group, supported by Radius Health, submits an NDA to FDA for elacestrant to treat some breast cancers.

FDA Covid Test Recommendations Based on UMass Study

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The UMass Chan Medical School says the results of its study of at-home Covid tests are in an FDA recommendation for serial testing...

Ex-FDA Court Expert Witness Challenged

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The federal court hearing a proton-pump inhibitor liability consolidated case is considering whether a former FDAer who was involv...