The US Food and Drug Administration (FDA) has granted approval to Formosa Pharmaceuticals and AimMax Therapeutics’ clobetasol propionate ophthalmic suspension 0.05% for post-operative inflammation and pain after ocular surgical procedure.
The European Medicines Agency (EMA) has validated two marketing authorization applications (MAAs) for Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan (Dato-DXd) for two types of cancer.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided positive opinion for the Janssen Pharmaceutical Companies of Johnson & Johnson’s CARVYKTI (cilta-cel) for earlier stage of relapsed and refractory multiple myeloma (RRMM) treatment.
Japan's Ministry of Health, Labour and Welfare (MHLW) has granted priority review for Astellas Pharma’s supplemental new drug application (sNDA) for PADCEV (enfortumab vedotin) and KEYTRUDA (pembrolizumab) combination to treat urothelial cancer.
The US Food and Drug Administration (FDA) has granted orphan drug designation for clinical-stage biopharmaceutical company Disc Medicine’s investigational therapy, DISC-3405, for the treatment of polycythemia vera (PV).
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.
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