Approvals

FDA accepts sNDA and grants priority review for Calliditas’ TARPEYO capsules

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).

FDA accepts Venatorx’s NDA for cefepime-taniborbactam antibiotic

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.

FDA approves nonprescription use of RiVive naloxone nasal spray

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.

EC approves AstraZeneca’s Soliris to treat refractory gMG in children, adolescents

The European Commission (EC) has granted approval for AstraZeneca’s Soliris (eculizumab) to treat refractory generalised myasthenia gravis (gMG) in children and adolescents.

NMPA accepts Overland ADCT BioPharma’s BLA for ZYNLONTA

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).

FDA grants approval for Veklury use in Covid-19 patients

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.

TGA grants provisional approval to Hansa’s Idefirix as desensitisation treatment

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.

FDA approves label update of Novartis’ Leqvio to treat high LDL-C

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.

FDA clears 280Bio’s IND to start Phase I trial of YL-17231

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.