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April 10, 2021

FDA Approves First AI Device to Detect Colon Lesions FDA Approves First AI Device to Detect Colon Lesions

The US Food and Drug Administration (FDA) on Friday announced its first-ever approval of an artificial intelligence device to help find colon lesions during colonoscopy. The […]
April 9, 2021

FDA Names Recall of Valiant Navion Stent Graft as Class I FDA Names Recall of Valiant Navion Stent Graft as Class I

The US Food and Drug Administration (FDA) has named Medtronic’s recent worldwide recall of unused Valiant Navion thoracic stent grafts as Class I, the label given to […]
April 9, 2021

FDA: Time to Move Away From Using Decontaminated Respirators FDA: Time to Move Away From Using Decontaminated Respirators

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The US Food and Drug Administration (FDA) today recommended that healthcare facilities […]
April 9, 2021

New Side Effects With AstraZeneca and Janssen COVID-19 Vaccines? New Side Effects With AstraZeneca and Janssen COVID-19 Vaccines?

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. In addition to the unusual blood clots linked to the AstraZeneca COVID-19 […]
April 5, 2021

FDA Clears Nonstimulant for ADHD in Kids 6 Years and Up FDA Clears Nonstimulant for ADHD in Kids 6 Years and Up

The US Food and Drug Administration (FDA) has approved the nonstimulant medication viloxazine extended-release capsules (Qelbree, Supernus Pharmaceuticals) for the treatment of attention deficit hyperactivity disorder […]
April 1, 2021

FDA Okays New Indication for Alirocumab in Homozygous FH FDA Okays New Indication for Alirocumab in Homozygous FH

The US Food and Drug Administration has approved alirocumab (Praluent, Regeneron Pharmaceuticals) injection as add-on therapy for adults with homozygous familial hypercholesterolemia, the agency announced. The proprotein convertase […]
March 31, 2021

Europe Approves Pemigatinib for Bile Duct Cancer Europe Approves Pemigatinib for Bile Duct Cancer

The European Commission has approved the oral targeted therapy pemigatinib (Pemazyre) for the treatment of locally advanced or metastatic cholangiocarcinoma, a rare cancer of the bile […]
March 29, 2021

EU Panel Endorses Duvelisib for CLL and Follicular Lymphoma EU Panel Endorses Duvelisib for CLL and Follicular Lymphoma

European Union approval has been recommended for duvelisib (Copiktra) for patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or refractory follicular lymphoma (FL) who have received at […]
March 29, 2021

First CAR T-Cell Therapy for Multiple Myeloma: Abecma First CAR T-Cell Therapy for Multiple Myeloma: Abecma

Chimeric antigen receptor (CAR) T-cell therapy, described as a “living drug,” is now available for patients with relapsed/refractory multiple myeloma who have been treated with four […]
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