Hematological Disorders

Syros’s tamibarotene gains FDA fast track status for AML treatment

Syros Pharmaceuticals has received fast track designation from the US Food and Drug Administration (FDA) for tamibarotene to treat newly…

EC approves Bristol Myers Squibb’s Reblozyl for first-line MDS treatment

The European Commission (EC) has granted expanded approval for Bristol Myers Squibb's (BMS) Reblozyl (luspatercept) as a first-line treatment for…

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…

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