Brazil's Health Regulatory Agency (ANVISA) has approved Orladeyo (berotralstat) for the prevention of hereditary angioedema (HAE) attacks in adult and pediatric patients aged 12 and older, offering a new oral treatment for those suffering from this genetic disorder.
Telix Pharmaceuticals has received fast track designation from the US Food and Drug Administration (FDA) for its investigational glioma imaging product, TLX101-CDx (Pixclara).
The UK National Institute for Health and Care Excellence (NICE) has recommended the routine use of Novartis' tisagenlecleucel (Kymriah), a chimeric antigen receptor T-cell (CAR-T) therapy, for children and young adults aged up to 25 years with B-cell acute lymphoblastic leukaemia (ALL).
The US Food and Drug Administration (FDA) has approved ViiV Healthcare’s Dovato (dolutegravir/lamivudine) to treat HIV-1 infection in adolescents.
Solid Biosciences has received the US Food and Drug Administration’s (FDA) rare pediatric disease designation for its gene therapy candidate for Duchenne muscular dystrophy (Duchenne), SGT-003.
Biostar Pharma has announced that its pipeline product, utidelone injectable (UTD1), has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of breast cancer brain metastasis (BCBM).
The US Food and Drug Administration (FDA) has approved Italfarmaco's Duvyzat (givinostat) to treat Duchenne Muscular Dystrophy (DMD) in individuals aged six years and above.
Takeda has received accelerated approval for a supplemental new drug application (sNDA) from the US Food and Drug Administration (FDA) for ICLUSIG (ponatinib) to treat Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
NeoImmuneTech, a company specialising in T cell-focused therapeutics, has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its NT-I7 (efineptakin alfa) (rhIL-7-hyFc), for the treatment of pancreatic cancer.
Oricell Therapeutics has announced the clearance of its Investigational New Drug (IND) application by the US Food and Drug Administration (FDA) for OriCAR-017, a new CAR-T cell therapy targeting GPRC5D, for the treatment of relapsed/refractory multiple myeloma (R/R MM).
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