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February 25, 2021

FDA OKs First ‘Targeted Treatment’ for Rare DMD Mutation FDA OKs First ‘Targeted Treatment’ for Rare DMD Mutation

The US Food and Drug Administration (FDA) has approved the antisense oligonucleotide casimersen (Amondys 45, Sarepta Therapeutics) injection for the treatment of patients with Duchenne muscular […]
February 20, 2021

FDA Warns About Potential Inaccuracies With Pulse Oximeters FDA Warns About Potential Inaccuracies With Pulse Oximeters

Pulse oximeters have become popular during the COVID-19 pandemic for people to track their oxygen saturation, but they may not always be accurate, the FDA cautioned […]
February 19, 2021

FDA: S-ICD Generator Recall Due to Short Circuit Risk Is Class I FDA: S-ICD Generator Recall Due to Short Circuit Risk Is Class I

A company-initiated recall of two models of EMBLEM S-ICD (Boston Scientific) subcutaneous implantable cardioverter defibrillator pulse generators has been categorized as Class I by the US […]
February 17, 2021

Medtronic Recalls Valiant Navion Thoracic Stent Grafts Medtronic Recalls Valiant Navion Thoracic Stent Grafts

Medtronic is voluntarily recalling unused Valiant Navion thoracic stent grafts worldwide after reports of stent fractures surfaced from the Valiant Evo Global clinical trial. Two patients […]
February 17, 2021

FDA Expands Sacubitril/Valsartan Indication to Embrace Some HFpEF FDA Expands Sacubitril/Valsartan Indication to Embrace Some HFpEF

The US Food and Drug Administration (FDA) has approved a groundbreaking expanded indication for sacubitril/valsartan (Entresto), making it the first drug in the United States indicated […]
February 16, 2021

FDA OKs Shockwave Intravascular Lithotripsy for Coronary Plaque FDA OKs Shockwave Intravascular Lithotripsy for Coronary Plaque

Shockwave Medical’s Intravascular Lithotripsy (IVL) system has received premarket approval from the US Food and Drug Administration (FDA) to treat severely calcified coronary artery disease, the […]
February 15, 2021

First Drug That Protects Against Chemo-Induced Myelosuppression First Drug That Protects Against Chemo-Induced Myelosuppression

A novel drug that offers multilineage protection from chemotherapy-induced myelosuppression has been approved by the US Food and Drug Administration. The drug, trilaciclib (Cosela, G1 Therapeutics) […]
February 11, 2021

FDA Approves Orphan Drug Evinacumab-dgnb for Homozygous FH FDA Approves Orphan Drug Evinacumab-dgnb for Homozygous FH

The US Food and Drug Administration has approved the fully human monoclonal antibody evinacumab-dgnb (Evkeeza, Regeneron Pharmaceuticals) for use on top of other cholesterol-modifying meds in […]
February 11, 2021

2021 ACIP Adult Schedule Released 2021 ACIP Adult Schedule Released

The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) has updated its recommended immunization schedule for adults for 2021. […]
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