September 22, 2021
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
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
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
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
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
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
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
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) […]
September 17, 2021
Three new cancer drugs have been recommended for approval in Europe, as well as new indications for two already marketed immunotherapies. The positive opinions were issued […]