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JAK Inhibitors Implement FDA Class Warning

[ Price : $8.95]

An FDA-ordered drug class warning begins appearing in labels of Janus kinase (JAK) inhibitors Pfizers Xeljanz (tofacitinib), Eli ...

RefleXion Breakthrough for Radiotherapy

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FDA grants RefleXion Medical a breakthrough device designation for its biology-guided radiotherapy for use in treating lung tumors...

Keytruda Gets Approval for Certain Melanoma Patients

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FDA approves Mercks Keytruda (pembrolizumab) for the adjuvant treatment of adult and pediatric (12 years and older) patients with ...

FDA OKs Rituxan plus Chemo for Pediatric Lymphoma

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FDA approves Genentechs Rituxan (rituximab) in combination with chemotherapy for pediatric patients with previously untreated, adv...

Members Sought for Mammography Panel

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Federal Register notice: FDA requests nominations for voting members to serve on CDRHs National Mammography Quality Assurance Advi...

Class 2 for Intraoperative Orthopedic Strain Sensor

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Federal Register notice: FDA classifies the intraoperative orthopedic strain sensor into Class 2 (special controls).

Trunk/Limb Electrical Stimulator in Class 2

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Federal Register notice: FDA classifies the trunk and limb electrical stimulator to treat headache into Class 2. (special controls...

Lilly EUA for Monoclonal Antibodies Expanded

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FDA revises an Eli Lilly emergency use authorization (EUA) for bamlanivimab and etesevimab to be used in younger pediatric patient...

No Imminent Retirement for Woodcock

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FDA acting commissioner Janet Woodcock plans to play a senior role at the agency if FDA commissioner nominee Robert Califf is conf...

Congress Should Revamp 510(k) Process: Opinion

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A Yale and Harvard opinion piece says Congress should use the upcoming Cures 2.0 bill draft and the reauthorization of the medical...