October 4, 2022
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
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
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
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
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
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
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
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 (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 […]