Genmab and Pfizer have announced that the US Food and Drug Administration (FDA) granted full approval to TIVDAK’s (tisotumab vedotin-tftv) supplemental Biologics License Application (sBLA) to treat patients with recurrent or metastatic cervical cancer who have experienced disease progression on or after chemotherapy.
Ractigen Therapeutics has received approval from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for saRNA therapy RAG-01.
Merck, referred as MSD outside the US and Canada, has confirmed that Health Canada has approved a new indication for PREVYMIS (letermovir) to prevent cytomegalovirus (CMV) disease in high risk adult kidney transplant recipients.
Brazil's Health Regulatory Agency (ANVISA) has approved Orladeyo (berotralstat) for the prevention of hereditary angioedema (HAE) attacks in adult and pediatric patients aged 12 and older, offering a new oral treatment for those suffering from this genetic disorder.
Telix Pharmaceuticals has received fast track designation from the US Food and Drug Administration (FDA) for its investigational glioma imaging product, TLX101-CDx (Pixclara).
The UK National Institute for Health and Care Excellence (NICE) has recommended the routine use of Novartis' tisagenlecleucel (Kymriah), a chimeric antigen receptor T-cell (CAR-T) therapy, for children and young adults aged up to 25 years with B-cell acute lymphoblastic leukaemia (ALL).
The US Food and Drug Administration (FDA) has approved ViiV Healthcare’s Dovato (dolutegravir/lamivudine) to treat HIV-1 infection in adolescents.
Solid Biosciences has received the US Food and Drug Administration’s (FDA) rare pediatric disease designation for its gene therapy candidate for Duchenne muscular dystrophy (Duchenne), SGT-003.
Biostar Pharma has announced that its pipeline product, utidelone injectable (UTD1), has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of breast cancer brain metastasis (BCBM).
Novartis has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to grant marketing authorisation for Fabhalta (iptacopan) to treat adults with paroxysmal nocturnal haemoglobinuria (PNH) who suffer from haemolytic anaemia.
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