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September 10, 2020

FDA Clears New Neurosurgical Port for Deep Brain Access FDA Clears New Neurosurgical Port for Deep Brain Access

The US Food and Drug Administration (FDA) has granted marketing clearance to the MindsEye Expandable Port (Minnetronix Medical) for deep brain access during neurosurgical procedures, the […]
September 8, 2020

Pralsetinib: Second Drug for RET+ NSCLC Approved in US Pralsetinib: Second Drug for RET+ NSCLC Approved in US

A second drug is now available in the United States for use in the treatment of patients with metastatic non–small cell lung cancer (NSCLC) that tests […]
September 4, 2020

EMA Panel Backs Revoking Authorization of Ulipristal for Fibroids EMA Panel Backs Revoking Authorization of Ulipristal for Fibroids

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended revoking marketing authorization of ulipristal acetate (Esmya, Gedeon Richter, and generic medicines) for uterine […]
September 3, 2020

Problems With Implanted Spinal Cord Stimulators Prompt FDA Action Problems With Implanted Spinal Cord Stimulators Prompt FDA Action

Between July 27, 2016, and July 27, 2020, the US Food and Drug Administration (FDA) received a total of 107,728 medical device reports (MDRs) related to […]
September 3, 2020

FDA OKs Somapacitan (Sogroya), First Once-Weekly Growth Hormone FDA OKs Somapacitan (Sogroya), First Once-Weekly Growth Hormone

The US Food and Drug Administration (FDA) has approved somapacitan (Sogroya, Novo Nordisk) for the replacement of endogenous growth hormone in adults with growth hormone deficiency […]
September 2, 2020

FDA Approves First Maintenance Therapy for AML FDA Approves First Maintenance Therapy for AML

The US Food and Drug Administration (FDA) has approved an oral form of azacitidine (Onureg) for use as maintenance therapy for patients with acute myeloid leukemia […]
September 1, 2020

FDA OKs New ‘Artificial Pancreas’ Medtronic 770G FDA OKs New ‘Artificial Pancreas’ Medtronic 770G

The US Food and Drug Administration (FDA) has approved the MiniMed 770G (Medtronic) automated insulin delivery system for children aged 2 to 6 years. The 770G […]
August 27, 2020

FDA Approves Point-of-Care COVID-19 Antigen Test FDA Approves Point-of-Care COVID-19 Antigen Test

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 approved marketing of the […]
August 27, 2020

FDA Approves Topical Antiandrogen for Acne FDA Approves Topical Antiandrogen for Acne

The Food and Drug Administration has approved clascoterone 1% cream for the topical therapy of acne, providing a treatment with a novel mechanism of action for […]
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