Hematological Disorders

FDA grants priority review for AstraZeneca’s Calquence sNDA

The US Food and Drug Administration (FDA) has accepted and granted priority review to AstraZeneca's supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL).

Pfizer and Abu Dhabi partner to boost sickle cell disease research

The Department of Health (DoH) Abu Dhabi in the UAE has entered into a memorandum of understanding (MoU) with Pfizer Gulf to bolster research in areas including sickle cell disease (SCD).

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).

Agios and Alnylam sign agreement for siRNA candidate

Agios Pharmaceuticals has signed a license agreement with Alnylam Pharmaceuticals for preclinical Small interfering RNA (siRNA) development candidate to treat polycythemia vera (PV).

Takeda submits New Drug Application for lanadelumab in Japan

Japan-based, R&D-driven Takeda Pharmaceutical Company Limited has submitted a New Drug Application (NDA) for lanadelumab to the Ministry of Health, Labour and Welfare (MHLW) in Japan.

USFDA grants FTD to efanesoctocog alfa for hemophilia A treatment

The U.S. Food and Drug Administration (FDA) has granted efanesoctocog alfa – earlier termed BIVV001 (rFVIIIFc-VWF-XTEN) – Fast Track Designation (FTD) for the treatment of patients suffering from hemophilia A.