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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 […]
April 2, 2020

FDA Calls for Market Removal of Ranitidine FDA Calls for Market Removal of Ranitidine

A problem with probable human carcinogen N-nitrosodimethylamine (NDMA) contamination in ranitidine, commonly known by the brand name Zantac, has led the Food and Drug Administration to call for […]
March 31, 2020

EMA Backs Fluad Tetra for Influenza Prophylaxis in the Elderly EMA Backs Fluad Tetra for Influenza Prophylaxis in the Elderly

The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has recommended granting marketing authorization for Fluad Tetra (Seqirus Netherlands BV), an […]
March 30, 2020

Class 1 Recall for Medtronic’s Flex Embolization Devices Class 1 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 system used to deliver the stent could fracture […]
March 30, 2020

FDA OKs Durvalumab Combo for Extensive-Stage SCLC FDA OKs Durvalumab Combo for Extensive-Stage SCLC

The US Food and Drug Administration has approved the immunotherapy durvalumab (Imfinzi, AstraZeneca) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of […]
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