Regulation

EMA CHMP provides positive opinion for Janssen’s multiple myeloma therapy

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 grants priority review for Astellas’ urothelial cancer regimen

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.

FDA grants orphan drug designation for Disc’s PV treatment

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).

US FDA grants ODD to NeoImmuneTech’s NT-I7 for pancreatic cancer treatment

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’s OriCAR-017 application secures FDA IND clearance

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).

Zokinvy gets Japanese approval for Progeria treatment

The Progeria Research Foundation (PRF) has announced the Japanese approval of Zokinvy (lonafarnib) for treating Progeria and processing-deficient Progeroid Laminopathies (PL).

US FDA updates Sanofi’s Dupixent label for atopic dermatitis

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 introduces Produodopa for advanced Parkinson’s in EU

AbbVie has announced the launch of Produodopa (foslevodopa/foscarbidopa), a new treatment for advanced Parkinson's disease (PD) patients in the European Union.

FDA grants priority review for Daiichi Sankyo-Merck’s lung cancer therapy

The US Food and Drug Administration (FDA) has granted priority review to Daiichi Sankyo and Merck’s biologics license application (BLA) for patritumab deruxtecan, to potentially treat non-small cell lung cancer (NSCLC) in adults.