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Human Drugs

JAK Inhibitors Implement FDA Class Warning

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

Medical Devices

RefleXion Breakthrough for Radiotherapy

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

Human Drugs

Keytruda Gets Approval for Certain Melanoma Patients

FDA approves Mercks Keytruda (pembrolizumab) for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage 2B or 2C melan...

Human Drugs

FDA OKs Rituxan plus Chemo for Pediatric Lymphoma

FDA approves Genentechs Rituxan (rituximab) in combination with chemotherapy for pediatric patients with previously untreated, advanced stage, CD20-po...

Federal Register

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 12/03/2021.

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 12/3/2021.

FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

Federal Register

Members Sought for Mammography Panel

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

Federal Register

Class 2 for Intraoperative Orthopedic Strain Sensor

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

Federal Register

Trunk/Limb Electrical Stimulator in Class 2

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