The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) has voted in favour of Bristol Myers Squibb (BMS) and 2seventy bio’s Abecma (idecabtagene vicleucel) for treating triple-class exposed relapsed or refractory multiple myeloma.
Johnson & Johnson has filed a supplemental biologics license application (sBLA) with the US Food and Drug Administration (FDA) seeking approval for TREMFYA (guselkumab)to treat moderately to severely active ulcerative colitis (UC).
iOnctura has received the US Food and Drug Administration’s (FDA) orphan drug designation (ODD) for its autotaxin inhibitor, cambritaxestat, for pancreatic 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.
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.
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