Gilead Sciences announced that the CHMP of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy (sacituzumab govitecan-hziy) in combination with… read more.
Roche announced that the CHMP has recommended the approval of Susvimo (ranibizumab injection) 100 mg/mL for the treatment of neovascular age-related macular degeneration (nAMD). Susvimo is intended for… read more.
Celcuity Inc. announced that the FDA approved Revtorpyk (gedatolisib) for the treatment of patients with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), locally… read more.
Takeda China announced that the National Medical Products Administration (NMPA) of China has approved the use of Orzeyful (oveporexton) for the treatment of narcolepsy type 1 (NT1) in… read more.
MannKind Corporation announced that the FDA has approved Furoscix ReadyFlow (furosemide injection) for the treatment of edema (fluid overload) in adults with heart failure (HF) or chronic kidney… read more.
Novartis announced that the FDA has granted traditional approval for Fabhalta (iptacopan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of… read more.
AstraZeneca’s fixed-dose triple-combination Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF (320/28.8/9.6μg)) has been recommended for approval in the European Union (EU) for the maintenance treatment of asthma in patients… read more.
GSK plc announced the FDA has approved Jideytro (zidesamtinib), a ROS1 selective inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung… read more.
NICE(UK): Pembrolizumab with chemoradiotherapy (external beam radiation therapy followed by brachytherapy) can be used, within its marketing authorisation, as an option for untreated International Federation of Gynecology and… read more.
According to the MHRA website, the MHRA approved Retifanlimab (Zynyz) as the first treatment given to adults with advanced Merkel cell skin cancer that has spread or returned… read more.
Novo Nordisk announced that the European Commission (EC) has granted marketing authorisation for Wegovy pill (once-daily oral semaglutide 25 mg) for the treatment of adults with obesity (BMI… read more.
Camurus announced that the FDA has accepted for review the resubmission of the New Drug Application (NDA) for CAM2029, octreotide extended-release injection, for the treatment of patients with… read more.
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