Novartis has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to grant marketing authorisation for Fabhalta (iptacopan) to treat adults with paroxysmal nocturnal haemoglobinuria (PNH) who suffer from haemolytic anaemia.
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).
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.
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