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August 3, 2020

FDA OKs Two Blood Tests to Estimate SARS-CoV-2 Antibodies FDA OKs Two Blood Tests to Estimate SARS-CoV-2 Antibodies

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The US Food and Drug Administration (FDA) has authorized the first two […]
August 3, 2020

FDA Approves Cannabidiol for Tuberous Sclerosis Complex FDA Approves Cannabidiol for Tuberous Sclerosis Complex

The cannabidiol (CBD) oral solution Epidiolex has been approved by the US Food and Drug Administration (FDA) for the new indication of treatment of seizures associated […]
August 3, 2020

FDA Approves New Drug for Diffuse Large B-Cell Lymphoma FDA Approves New Drug for Diffuse Large B-Cell Lymphoma

A novel drug, tafasitamab-cxix (Monjuvi, MorphoSys US Inc), has been approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with […]
July 31, 2020

FDA Approves Triple Drug Combo for Melanoma FDA Approves Triple Drug Combo for Melanoma

The US Food and Drug Administration (FDA) has approved the triple-therapy combination of atezolizumab (Tecentriq) plus cobimetinib (Cotellic) and vemurafenib (Zelboraf) for the treatment of BRAF […]
July 29, 2020

EMA Panel Backs Filgotinib (Jyseleca) for Rheumatoid Arthritis EMA Panel Backs Filgotinib (Jyseleca) for Rheumatoid Arthritis

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of filgotinib (Jyseleca) for moderate to severe active […]
July 29, 2020

EMA Backs Dapivirine Vaginal Ring for HIV Prevention Outside of EU EMA Backs Dapivirine Vaginal Ring for HIV Prevention Outside of EU

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on the dapivirine vaginal ring for […]
July 27, 2020

EMA Green Light for Avapritinib for GIST, Acalabrutinib for CLL EMA Green Light for Avapritinib for GIST, Acalabrutinib for CLL

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a thumbs up to two new oncology drugs.  The Committee has recommended […]
July 24, 2020

FDA Okays New CAR T Therapy, First for Mantle Cell Lymphoma FDA Okays New CAR T Therapy, First for Mantle Cell Lymphoma

The US Food and Drug Administration (FDA) today granted accelerated approval to brexucabtagene autoleucel (Tecartus, Kite Pharma), the first approved chimeric antigen receptor (CAR) T cell therapy for […]
July 24, 2020

CHMP Backs Bupivacaine/Meloxicam (Zynrelef) for Postop Pain CHMP Backs Bupivacaine/Meloxicam (Zynrelef) for Postop Pain

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of the fixed-dose combination of bupivacaine and meloxicam […]
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