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June 1, 2020

EU Green Light for Canagliflozin to Slow Diabetic Kidney Disease EU Green Light for Canagliflozin to Slow Diabetic Kidney Disease

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending that approval for the sodium-glucose cotransporter 2 […]
June 1, 2020

FDA Approves Drug Combo for Heavy Bleeding Related to Fibroids FDA Approves Drug Combo for Heavy Bleeding Related to Fibroids

The Food and Drug Administration approved a medication for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. The medication, marketed as […]
April 16, 2020

Mitomycin Approved for Low-Grade Upper Tract Urothelial Cancer Mitomycin Approved for Low-Grade Upper Tract Urothelial Cancer

The Food and Drug Administration has approved mitomycin (Jelmyto), the first therapy for adults with low-grade upper tract urothelial cancer. “This is the first approval specifically […]
April 9, 2020

Encorafenib Now Approved for BRAF-Positive Colorectal Cancer Encorafenib Now Approved for BRAF-Positive Colorectal Cancer

The targeted agent encorafenib (Braftovi, Array BioPharma, now part of Pfizer) has been approved by the US Food and Drug Administration (FDA) for use in BRAF-positive […]
April 7, 2020

FDA Class 1 Recall of Imager II Angiographic Catheters FDA Class 1 Recall of Imager II Angiographic Catheters

Boston Scientific is recalling their Imager II 5F angiographic catheters in the United States because the catheter tip could become detached during a patient procedure or during procedure […]
April 6, 2020

FDA Updates Pregnancy Information on Interferon-β Drug Labels FDA Updates Pregnancy Information on Interferon-β Drug Labels

The US Food and Drug Administration (FDA) has updated the prescribing information for peginterferon β-1a (Plegridy, Biogen) and interferon β-1a (Avonex, Biogen) regarding use during pregnancy […]
April 6, 2020

First Advance in MDS for Decade: Luspatercept for Anemia First Advance in MDS for Decade: Luspatercept for Anemia

The US Food and Drug Administration (FDA) has approved luspatercept (Reblozyl, Bristol-Myers Squibb/Acceleron) for the treatment of anemia in patients with myelodysplastic syndromes (MDS). The green light represents […]
April 4, 2020

FDA Approves First Rapid Antibody Test for COVID-19 FDA Approves First Rapid Antibody Test for COVID-19

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s  Coronavirus Resource Center. The U.S. Food and Drug Administration has granted Cellex an emergency use […]
April 3, 2020

EMA Restricts Fosfomycin Use Following Evidence Review EMA Restricts Fosfomycin Use Following Evidence Review

The European Medicines Agency (EMA) has recommended a number of changes regarding the use of fosfomycin-based antibiotics, including recommending the suspension of use of pediatric and […]
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