Hematological Disorders
Centessa’s haemophilia therapy wins FDA fast track designation
The US Food and Drug Administration (FDA) has granted Centessa Pharmaceuticals’ activated Protein C (APC) inhibitor SerpinPC a fast track…
Sobi agrees to buy CTI BioPharma for $1.7bn
Swedish Orphan Biovitrum (Sobi) has entered into a definitive agreement to buy biopharmaceutical company CTI BioPharma in an all-cash deal…
AbbVie reports rise in full-year 2022 net revenues
AbbVie has reported full-year 2022 net revenues of $58.054bn, representing a 3.3% rise on a reported basis and 5.1% on…
Health Canada grants approval for Sobi’s PNH therapy
Health Canada has granted approval for Swedish Orphan Biovitrum (Sobi) affiliate Sobi North America’s Empaveli (pegcetacoplan) to treat adults with paroxysmal nocturnal hemoglobinuria (PNH),…
MEI and Kyowa Kirin to discontinue development of zandelisib outside Japan
MEI Pharma and Kyowa Kirin have announced plans to discontinue the international development of investigational cancer therapy, zandelisib, for B-cell…
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FDA grants approval for CSL’s haemophilia B gene therapy
The US Food and Drug Administration (FDA) has granted approval for CSL Behring’s adeno-associated virus vector-based gene therapy, Hemgenix (etranacogene…
US FDA accepts AbbVie’s lymphoma treatment application for priority review
The US Food and Drug Administration (FDA) has accepted AbbVie’s Biologics License Application (BLA) of epcoritamab (DuoBody-CD3xCD20) to treat adults with…
MHRA grants marketing authorisation for Oncopeptides’ multiple myeloma drug
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Oncopeptides’ Pepaxti (melphalan flufenamide; melflufen) along with dexamethasone…
US FDA grants approval for Janssen’s Tecvayli to treat multiple myeloma
The US Food and Drug Administration (FDA) has granted approval for the Janssen Pharmaceutical Companies of Johnson & Johnson’s (J&J) Tecvayli (teclistamab-cqyv) to…
Gilead partners with MacroGenics for bispecific antibody development
Gilead Sciences has entered an exclusive option and partnership agreement with MacroGenics for developing bispecific antibodies. Under the deal, the companies…