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October 4, 2022

EMA Issues Positive Opinion on the Safety of Filgotinib EMA Issues Positive Opinion on the Safety of Filgotinib

The scientific committee of the European Medicines Agency (EMA) has issued a positive opinion of the type II variation application of filgotinib (Jyseleca, Galapagos NV) based […]
October 3, 2022

FDA Approves Futibatinib for Certain Biliary Tract Cancers FDA Approves Futibatinib for Certain Biliary Tract Cancers

The US Food and Drug Administration (FDA) has granted an accelerated approval for a new drug, futibatinib (Lytgobi), to be used for patients with a certain […]
September 30, 2022

Class I Recall of LifeSPARC Advanced Circulatory Support System Class I Recall of LifeSPARC Advanced Circulatory Support System

Device maker LivaNova (TandemLife) has recalled the LifeSPARC controller, part of the LifeSPARC system, because of a software malfunction that may cause the controller’s monitoring feature […]
September 29, 2022

FDA OKs Novel ALS Drug, Despite Unusual Path to Approval FDA OKs Novel ALS Drug, Despite Unusual Path to Approval

The US Food and Drug Administration (FDA) has approved sodium phenylbutyrate/taurursodiol (Relyvrio, Amylyx Pharmaceuticals), a novel drug to treat amyotrophic lateral sclerosis (ALS). The approval was […]
September 29, 2022

FDA Clears Nexpowder Endoscopic Hemostasis System FDA Clears Nexpowder Endoscopic Hemostasis System

The US Food and Drug Administration has cleared the Nexpowder endoscopic hemostasis system. Nexpowder (Medtronic) uses a noncontact, nonthermal, nontraumatic hemostatic powder that is sprayed through […]
September 29, 2022

FDA Approves Dupilumab for Treatment of Prurigo Nodularis FDA Approves Dupilumab for Treatment of Prurigo Nodularis

The Food and Drug Administration has approved dupilumab for treating adults with prurigo nodularis, the first treatment approved for this indication, according to a press release […]
September 26, 2022

FDA Clears New AI Device to Aid Polyp Detection FDA Clears New AI Device to Aid Polyp Detection

The US Food and Drug Administration (FDA) has granted 510(k) marketing clearance to a new artificial intelligence (AI)–assisted polyp detection device for use during colorectal cancer […]
September 21, 2022

FDA OKs Sodium Thiosulfate for Ototoxicity Risk in Peds Cancer FDA OKs Sodium Thiosulfate for Ototoxicity Risk in Peds Cancer

The US Food and Drug Administration (FDA) has approved sodium thiosulfate (Pedmark, Fennec Pharmaceuticals) injection to reduce the risk for ototoxicity associated with cisplatin in pediatric […]
September 20, 2022

Vutrisiran Receives EU Approval for hAATR Amyloidosis Vutrisiran Receives EU Approval for hAATR Amyloidosis

Vutrisiran (Amvuttra) has been approved by the European Commission (EC) for treatment of hereditary transthyretin-mediated (hATTR) amyloidosis in adults with stage 1 or 2 polyneuropathy, the […]
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