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September 22, 2021

FDA Approves First Topical JAK Inhibitor for Atopic Dermatitis FDA Approves First Topical JAK Inhibitor for Atopic Dermatitis

The Food and Drug Administration today gave the nod to topical ruxolitinib cream for the treatment of non-immunocompromised patients with mild to moderate atopic dermatitis ages […]
September 22, 2021

First AI Pathology Program Approved: Helps Detect Prostate Cancer First AI Pathology Program Approved: Helps Detect Prostate Cancer

The US Food and Drug Administration (FDA) has authorized marketing of artificial intelligence (AI) software to help pathologists detect prostate cancer. The program, called Paige Prostate, […]
September 21, 2021

FDA Approval for Tisotumab Vedotin in Advanced Cervical Cancer FDA Approval for Tisotumab Vedotin in Advanced Cervical Cancer

The US Food and Drug Administration (FDA) has granted accelerated approval to tisotumab vedotin-tftv (Tivdak, Seagen/Genmab) for the treatment of adult patients with recurrent or metastatic […]
September 20, 2021

FDA Approves Abbott’s Portico Valve for TAVR FDA Approves Abbott’s Portico Valve for TAVR

The US Food and Drug Administration has approved the Portico with FlexNav (Abbott) transcatheter aortic valve replacement (TAVR) system for patients with “symptomatic, severe aortic stenosis […]
September 20, 2021

FDA Class I Recall for Medtronic’s Flex Embolization Devices FDA Class I Recall for Medtronic’s Flex Embolization Devices

Medtronic is recalling the Pipeline Flex embolization device and Pipeline Flex embolization device with shield technology because the delivery system’s wire and tubes could fracture and […]
September 20, 2021

FDA Approves Ranibizumab Biosimilar FDA Approves Ranibizumab Biosimilar

The US Food and Drug Administration (FDA) has approved the first biosimilar for ophthalmology, Byooviz (ranibizumab-nuna), which will be indicated for neovascular (wet) age-related macular degeneration […]
September 17, 2021

European Agency Recommends Two New Adalimumab Biosimilars European Agency Recommends Two New Adalimumab Biosimilars

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended marketing authorization this week for two new adalimumab biosimilars, Hukyndra and Libmyris. The biosimilars, […]
September 17, 2021

FDA Panel Backs Pfizer’s COVID Booster for 65 and Older, High Risk FDA Panel Backs Pfizer’s COVID Booster for 65 and Older, High Risk

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. A US Food and Drug Administration (FDA) advisory panel voted unanimously today […]
September 17, 2021

EMA Endorses Injectable Malaria Drug Artesunate EMA Endorses Injectable Malaria Drug Artesunate

The European Medicines Agency’s human medicines committee has recommended approval for an intravenous treatment for severe malaria. The Committee for Medical Products for Human Use (CHMP) […]
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