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June 22, 2022

FDA Recalls SafeStar 55 Breathing System Filters FDA Recalls SafeStar 55 Breathing System Filters

The US Food and Drug Administration (FDA) issued a Class I product recall for the SafeStar 55 Breathing System Filter. The manufacturer, Germany based Draeger Inc, […]
June 18, 2022

FDA Panel Rejects Pimavanserin for Alzheimer’s Psychosis FDA Panel Rejects Pimavanserin for Alzheimer’s Psychosis

A US Food and Drug Administration (FDA) advisory panel has rejected the atypical antipsychotic pimavanserin (Nuplazid, Acadia Pharmaceuticals) for the treatment of Alzheimer’s disease psychosis (ADP). […]
June 17, 2022

FDA Approves Risankizumab (Skyrizi) for Crohn’s Disease FDA Approves Risankizumab (Skyrizi) for Crohn’s Disease

The US Food and Drug Administration (FDA) has approved risankizumab-rzaa (Skyrizi, AbbVie) for a third indication — treatment of moderately to severely active Crohn’s disease in […]
June 14, 2022

FDA OKs Vutrisiran for hATTR Amyloidosis With Polyneuropathy FDA OKs Vutrisiran for hATTR Amyloidosis With Polyneuropathy

The US Food and Drug Administration (FDA) has approved vutrisiran (Amvuttra, Alnylam Pharmaceuticals) for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults, the […]
June 14, 2022

FDA Clears First of Robotic Exoskeleton for Multiple Sclerosis FDA Clears First of Robotic Exoskeleton for Multiple Sclerosis

The US Food and Drug Administration (FDA) has cleared the first exoskeleton device for use in the rehabilitation of patients with multiple sclerosis (MS). The FDA […]
June 13, 2022

FDA OKs First Systemic Treatment for Alopecia Areata FDA OKs First Systemic Treatment for Alopecia Areata

The US Food and Drug Administration (FDA) today approved baricitinib oral tablets as the first systemic treatment for adult patients with severe alopecia areata. The disorder […]
June 13, 2022

FDA Committee Unanimous on Two Gene Therapies FDA Committee Unanimous on Two Gene Therapies

A US Food and Drug Administration advisory committee gave a unanimous thumbs up to two new gene therapies: betibeglogene autotemcel (beti-cel) for the treatment of a […]
June 10, 2022

FDA Alert: Don’t Use OTC Products to Remove Skin Spots, Moles FDA Alert: Don’t Use OTC Products to Remove Skin Spots, Moles

Dr Adam Friedman Those moles, skin tags, and liver spots should stay on your skin until you see a doctor, according to a new alert from […]
June 8, 2022

FDA Approves Brolucizumab for Diabetic Macular Edema FDA Approves Brolucizumab for Diabetic Macular Edema

The US Food and Drug Administration (FDA) has approved brolucizumab (Beovu) for treatment of diabetic macular edema (DME), but included a warning about retinal vasculitis and […]
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