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December 2, 2022

FDA Approves Olutasidenib (Rezlidhia) for Certain Patients With AML FDA Approves Olutasidenib (Rezlidhia) for Certain Patients With AML

The US Food and Drug Administration (FDA) has approved olutasidenib (Rezlidhia) for use in certain patients with relapsed or refractory (R/R) acute myeloid leukemia (AML). Specifically, […]
December 1, 2022

Another Recall Related to Medtronic HVAD System Another Recall Related to Medtronic HVAD System

Medtronic has issued a recall of the controller driveline cover of the company’s HeartWare Ventricular Assist Device (HVAD) system. The Medtronic HVAD system was approved as […]
December 1, 2022

FDA OKs First Fecal Transplant Therapy for Recurrent C difficile FDA OKs First Fecal Transplant Therapy for Recurrent C difficile

The US Food and Drug Administration (FDA) has approved the first fecal microbiota product to prevent recurrence of Clostridioides difficile infection (CDI) in people aged 18 […]
November 29, 2022

Atezolizumab Bladder Cancer Indication Withdrawn in US Atezolizumab Bladder Cancer Indication Withdrawn in US

Atezolizumab (Tecentriq) is no longer approved in the United States for use in certain patients with bladder or urinary tract cancer. The drug is an anti-PD-L1 […]
November 25, 2022

FDA Rejects Piziotinib for Certain Types of NSCLC FDA Rejects Piziotinib for Certain Types of NSCLC

The US Food and Drug Administration (FDA) has announced that it will not approve poziotinib (Spectrum Pharmaceuticals) for the treatment of certain patients with nonsmall-cell lung […]
November 23, 2022

FDA Approves First Gene Therapy for Hemophilia B FDA Approves First Gene Therapy for Hemophilia B

The U.S. Food and Drug Administration has approved etranacogene dezaparvovec (EtranaDez), the first gene therapy option for adults with hemophilia B who currently use factor IX prophylaxis therapy, […]
November 22, 2022

FDA Alert: ‘Substantial’ Hypocalcemia Risk with Prolia Use FDA Alert: ‘Substantial’ Hypocalcemia Risk with Prolia Use

The US Food and Drug Administration (FDA) issued an alert today that cited preliminary evidence for a “substantial risk” for severe and symptomatic hypocalcemia and serious […]
November 18, 2022

FDA Approves First-Ever Agent to Delay Type 1 Diabetes Onset FDA Approves First-Ever Agent to Delay Type 1 Diabetes Onset

The US Food and Drug Administration has approved the anti-CD3 monoclonal antibody teplizumab-mzwv (Tzield, Provention Bio) to delay the onset of clinical type 1 diabetes in […]
November 10, 2022

Anti-Vax Doctor Simone Gold Sued by Organization She Founded Anti-Vax Doctor Simone Gold Sued by Organization She Founded

America’s Frontline Doctors is suing one of its founders in a battle for control over the controversial group, which gained national notoriety for spreading misinformation about […]
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