Hematological Disorders
Takeda’s ADZYNMA gains Japanese approval for cTTP treatment
Takeda has announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved ADZYNMA Intravenous Injection 1500 (apadamtase…
BMS’ cell therapy Abecma gains EC approval for multiple myeloma
The European Commission (EC) has approved Bristol Myers Squibb’s (BMS) cell therapy Abecma (idecabtagene vicleucel; ide-cel) to treat adults with relapsed…
Akums introduces Hydroxyurea oral suspension for sickle cell disease
Indian company Akums Drugs and Pharmaceuticals has introduced Hydroxyurea oral suspension, the country’s first room temperature-stable drug for treating sickle…
FDA committee endorses Johnson & Johnson’s multiple myeloma therapy
The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended Johnson & Johnson’s Carvykti (ciltacabtagene autoleucel,…
MHRA authorises Daiichi Sankyo quizartinib for AML for marketing
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation to Daiichi Sankyo for quizartinib (Vanflyta) for…
CARsgen’s CAR-T therapy for multiple myeloma gains NMPA approval
The National Medical Products Administration (NMPA) of China has approved CARsgen Therapeutics' new drug application for zevorcabtagene autoleucel to treat…
EMA CHMP recommends AstraZeneca’s Voydeya for PNH treatment
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended AstraZeneca's oral Factor D…
MHRA revokes Novartis’ Adakveo authorisation for sickle cell disease
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has revoked a conditional marketing authorisation for Novartis Pharmaceuticals' Adakveo 10mg/ml…
Grifols gears up for FDA approval of fibrinogen replacement therapy
Spanish pharmaceutical company Grifols has reported positive Phase III trial data for its fibrinogen concentrate, AdFIrst (BT524) as a treatment…
Regeneron’s linvoseltamab application accepted for review
Regeneron Pharmaceuticals marketing authorisation application (MAA) for linvoseltamab has received acceptance for review from the European Medicines Agency (EMA) to…