Agios Pharmaceuticals Inc. announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for the supplemental New Drug Application (sNDA) of Pyrukynd (mitapivat),… read more.
The FDA has updated Skysona’s indication, allowing it to be used only in patients who do not have an available human leukocyte antigen (HLA)-matched donor for stem cell… read more.
Researchers report that treating complicated Staphylococcus aureus bloodstream infections with two intravenous (IV) doses of the antibiotic dalbavancin seven days apart is as effective as treatment with daily… read more.
Bayer announced that the FDA has approved Jivi, a recombinant DNA-derived, extended half-life factor VIII concentrate, for use in pediatric patients 7 years of age and older with… read more.
The Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Bosulif…. read more.
Sobi will be presenting a wide range of clinical study updates at the annual International Society on Thrombosis and Haemostasis (ISTH) Congress in Washington (21-25 June). With ten… read more.
Statin therapy reduces the risk of death significantly for patients with sepsis, researchers reported on June 6, 2025 in Frontiers in Immunology. As background, the authors noted that… read more.
Hympavzi (marstacimab) from Pfizer has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to treat haemophilia A or B in adult and paediatric patients…. read more.
Nurix Therapeutics, Inc. announced that data from the Company’s ongoing Phase 1a/b clinical trial of bexobrutideg (NX-5948) in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and Waldenström macroglobulinemia… read more.
Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who were taking cholesterol-lowering statin medications at the start of their cancer treatment had a 61% lower… read more.
Hydroxyurea therapy, a standard treatment for children with sickle cell disease (SCD), remains effective over the long term for reducing emergency department visits and hospital days among pediatric… read more.
NICE (UK): burosumab is recommended, within its marketing authorisation, for treating X‑linked hypophosphataemia (XLH) with radiographic evidence of bone disease in children aged 1 year and over, and… read more.
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