The US Food and Drug Administration (FDA) has accepted Calliditas Therapeutics’ supplemental New Drug Application (sNDA) submission and granted priority review for full approval of TARPEYO (budesonide) delayed release capsules to treat IgA nephropathy (IgAN).
The US Food and Drug Administration (FDA) has accepted Venatorx Pharmaceuticals’ new drug application (NDA) for cefepime-taniborbactam antibiotic for the potential treatment of complicated urinary tract infections (cUTI) including pyelonephritis, in adults.
The US Food and Drug Administration (FDA) has granted approval to RiVive, developed by Harm Reduction Therapeutics, for the emergency treatment of known or suspected overdose caused due to opioid.
The European Commission (EC) has granted approval for AstraZeneca’s Soliris (eculizumab) to treat refractory generalised myasthenia gravis (gMG) in children and adolescents.
The China National Medical Products Administration (NMPA) has accepted and granted priority review to Overland ADCT BioPharma’s biologics license application (BLA) for ZYNLONTA (loncastuximab tesirine-lpyl).
The US Food and Drug Administration (FDA) has granted clearance to Gilead Sciences’ supplemental new drug application (sNDA) of Veklury (remdesivir) for use in Covid-19 patients.
The Australian Therapeutic Goods Administration (TGA) has granted provisional approval to Hansa Biopharma’s Idefirix (imlifidase) as desensitisation treatment for highly sensitised patients before kidney transplantation either from living or deceased donors.
The US Food and Drug Administration (FDA) has approved a label update of Novartis’ Leqvio (inclisiran) to allow earlier use in patients suffering with high LDL-C who have an increased risk of heart disease, as an adjunct to diet and statin therapy.
The US Food and Drug Administration (FDA) has granted clearance to 280Bio’s investigational new drug (IND) application, thereby enabling initiation of a Phase I study of YL-17231 to treat patients with advanced cancer with RAS mutations.
The European Commission has granted full Marketing Authorization (MA) to Novavax’s Nuvaxovid (NVX-CoV2373) vaccine for Covid-19.
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