Takeda Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for the supplemental Biologics License Application (sBLA) of an expanded indication for Vonvendi, for routine prophylaxis in adults with von Willebrand disease (VWD), including Types 1 and 2.
Eli Lilly has received the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to olomorasib, an investigational KRAS G12C inhibitor.
Aldeyra Therapeutics has secured orphan designation from the European Medicines Agency (EMA) for ADX-2191, an intravitreal injection of methotrexate, intended for primary large B-cell lymphomas in immune-privileged sites, such as primary vitreoretinal lymphoma.
The US Food and Drug Administration (FDA) has granted orphan drug designation for AlzeCure Pharma’s pain drug candidate, ACD440.
Innovent Biologics has received the National Medical Products Administration (NMPA) of China’s approval for mazdutide for chronic weight management in adults with obesity or overweight.
Ferrer's FNP-223 has secured fast-track designation from the US Food and Drug Administration (FDA), intended to slow down the development of progressive supranuclear palsy (PSP), a neurodegenerative disease.
The US Food and Drug Administration (FDA) has granted fast track designation to SolasCure's investigational Aurase Wound Gel (AWG) for treating calciphylaxis ulcers.
The European Commission (EC) has granted Italfarmaco a conditional marketing authorisation for its new histone deacetylase (HDAC) inhibitor, Duvyzat (givinostat), to treat Duchenne muscular dystrophy (DMD) in ambulant patients aged six years and older.
Henlius has secured orphan drug designation (ODD) for its anti-HER2 monoclonal antibody, HLX22, from the European Commission (EC) for gastric cancer treatment.
Roche’s Genentech has gained the US Food and Drug Administration (FDA) approval for Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic retinopathy (DR).
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