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).
The Progeria Research Foundation (PRF) has announced the Japanese approval of Zokinvy (lonafarnib) for treating Progeria and processing-deficient Progeroid Laminopathies (PL).
The US Food and Drug Administration (FDA) has approved an update to the label for Sanofi’s Dupixent (dupilumab), which now includes efficacy and safety data for patients aged 12 years and older with atopic dermatitis, specifically addressing moderate-to-severe hand and foot involvement.
AbbVie has announced the launch of Produodopa (foslevodopa/foscarbidopa), a new treatment for advanced Parkinson's disease (PD) patients in the European Union.
SELLAS Life Sciences Group has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for SLS009, a new CDK9 inhibitor aimed at treating relapsed/refractory Peripheral T-cell Lymphomas (PTCL).
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