BEIJING, China — Huahui Health announced that China National Medical Products Administration (NMPA) has granted conditional approval to its Libevitug injection for the treatment of chronic hepatitis D virus infection in adults with or without compensated cirrhosis. Libevitug is a human monoclonal antibody targeting the PreS1 domain of the large envelope protein of...
treatment News
Enrollment ongoing in atrasentan pivotal phase 3 ALIGN study in IgAN and phase 2 AFFINITY study in proteinuric glomerular diseases Chinook expects to present data from the IgAN patient cohort of the phase 2 AFFINITY study in the first half of 2022, with data from one or more additional cohorts expected...
CHENGDU, China — Chengdu Chipscreen NewWay Biosciences Co., Ltd. announced that on January 5, 2024, the dosing of the first patient for a phase I clinical trial of a PD-1/CD40 bispecific antibody (bsAb), NWY001, at Sun Yat-Sen University Cancer Center in China, the trial-leading institution. The trial is a multi-center,...
SOUTH PLAINFIELD, N.J. – PTC Therapeutics, Inc. (NASDAQ: PTCT), today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Evrysdi™ (risdiplam) for the treatment of 5q spinal muscular atrophy (SMA) in patients 2 months and older, with a clinical...
PRINCETON, N.J. — Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo® (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial...
Basel – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of ENSPRYNG® (satralizumab) as the first subcutaneous treatment option for adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody...
Basel, Switzerland – Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Ocrevus® (ocrelizumab) intravenous (IV) infusion for the treatment of paediatric patients aged 10 years and older with relapsing forms of...
BASEL, Switzerland – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a subcutaneous (SC) formulation of Lunsumio® (mosunetuzumab) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL)...
FOSTER CITY, Calif. — Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab), for the treatment of adult patients with...
SYDNEY, Australia — Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, is pleased to announce that enrolment has opened for its expansion study in bile tract cancer (cholangiocarcinoma) patients, having completed the fifth, high dose cohort in the intratumoural (IT) arm of the monotherapy dose escalation study evaluating its...