Harbour BioMed declared that the U.S. FDA has given the go-ahead for the IND application, permitting the initiation of clinical studies for its inaugural Antibody Drug Conjugate (ADC) project, HBM9033.
The FDA has given Mallinckrodt the green light to market Lisdexamfetamine Dimesylate Capsules, a product intended to mitigate Attention-Deficit/Hyperactivity Disorder (ADHD).
On September 1, 2023, the NMPA officially approved a new indication for AstraZeneca's blood cancer product, Acalabrutinib, for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
On September 1, 2023, Mabspace Biosciences registered an international multicenter Phase III clinical trial on the Drug Clinical Trial Registration and Information Publicity Platform.
Recently, Neurocrine Biosciences announced new data for the VMAT2 inhibitor drug Ingrezza (valbenazine) capsules, including preliminary results from the Phase III KINECT-HD clinical trial.
Recently, Bristol Myers Squibb has announced the latest long-term follow-up results of two Phase 3 studies that assessed the treatment efficacy of Camzyos (mavacamten).
Recently, Roche announced that its PD-L1 targeted antibody, Tecentriq(atezolizumab), has been approved for marketing in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA).
the combined therapy of KRAS G12D inhibitor MRTX1133 and immune checkpoint inhibitors can cause sustained tumor elimination and significantly improve the survival outcomes in mice.
On August 29, FibroGen announced that the CTGF antibody Pamrevlumab for the treatment of Duchenne Muscular Dystrophy (DMD) in the phase three LELANTOS clinical trial did not achieve its primary NSAA endpoint and crucial secondary endpoints.