Regulation

iOnctura receives orphan drug status for pancreatic cancer therapy

iOnctura has received the US Food and Drug Administration’s (FDA) orphan drug designation (ODD) for its autotaxin inhibitor, cambritaxestat, for pancreatic cancer.

UK NICE recommends GSK’s Dostarlimab regimen for womb cancer

The UK National Institute for Health and Care Excellence (NICE) has recommended GSK’s Dostarlimab, marketed as Jemperli, for use with chemotherapy in treating specific advanced or recurrent womb cancers.

FDA approves Formosa-AimMax’s post-surgery eye care treatment

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.

EMA validates Daiichi Sankyo-AstraZeneca’s cancer therapy applications

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.

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).