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May 28, 2020

Class I Recall for Medtronic’s HeartWare HVAD Pump Parts Class I Recall for Medtronic’s HeartWare HVAD Pump Parts

Medtronic is recalling its HeartWare ventricular assist device (HVAD) Pump Outflow Graft and Outflow Graft Strain Relief because the outflow graft may tear and the strain […]
May 27, 2020

FDA Approves New Biologic for Atopic Dermatitis in Children FDA Approves New Biologic for Atopic Dermatitis in Children

The Food and Drug Administration has approved dupilumab for children aged 6-11 years with moderate to severe atopic dermatitis, the manufacturers announced. The new indication is […]
May 27, 2020

‘Superpotent’ Lots of NP Thyroid for Hypothyroidism Recalled in US ‘Superpotent’ Lots of NP Thyroid for Hypothyroidism Recalled in US

Acella Pharmaceuticals has voluntarily recalled 13 lots of its NP Thyroid medication, a combination of levothyroxine (T4) and liothyronine (T3) prescribed for hypothyroidism, because the company […]
May 26, 2020

FDA Approves Phexxi for Use as On-Demand Contraceptive FDA Approves Phexxi for Use as On-Demand Contraceptive

The Food and Drug Administration has approved Phexxi (lactic acid, citric acid and potassium bitartrate) to prevent pregnancy in women of reproductive potential. Evofem Biosciences expects […]
May 22, 2020

FDA OKs Apomorphine Sublingual Film for ‘Off’ Episodes in PD FDA OKs Apomorphine Sublingual Film for ‘Off’ Episodes in PD

The US Food and Drug Administration (FDA) has approved apomorphine hydrochloride sublingual film (Kynmobi, Sunovion) for the acute, intermittent treatment of ‘off’ episodes in patients with […]
May 20, 2020

FDA Approves Olaparib for Certain Metastatic Prostate Cancers FDA Approves Olaparib for Certain Metastatic Prostate Cancers

The US Food and Drug Administration approved olaparib (Lynparza, AstraZeneca) for deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate […]
May 19, 2020

First PARP Inhibitor Approved for Metastatic Prostate Cancer First PARP Inhibitor Approved for Metastatic Prostate Cancer

A completely new approach to the treatment of prostate cancer is now available to clinicians through the approval of the first PARP inhibitor for use in […]
May 15, 2020

FDA Issues Alert on Accuracy of Abbott ID NOW Rapid Test FDA Issues Alert on Accuracy of Abbott ID NOW Rapid Test

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Preliminary data suggest that Abbott Labs’ ID NOW rapid test for COVID-19, […]
May 15, 2020

FDA Approves Pomalidomide for Kaposi Sarcoma FDA Approves Pomalidomide for Kaposi Sarcoma

The US Food and Drug Administration (FDA) has granted accelerated approval to pomalidomide (Pomalyst, Bristol-Myers Squibb) for the treatment of AIDS-related Kaposi sarcoma that is resistant […]
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