FDA approves Eli Lilly's Inluriyo alongside Verzenio in breast cancer
The FDA cleared Eli Lilly to market a combination of its oral selective estrogen receptor degrader Inluriyo (imlunestrant) and its CDK4/6 inhibitor Verzenio (abemaciclib).
Zealand Pharma's Zeydovio wins European regulatory panel backing
The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of Zealand Pharma's Zeydovio (glepaglutide), a long-acting GLP-2 analog for short bowel syndrome.
FDA approves Ultragenyx gene therapy Fayuvi for Sanfilippo syndrome type A
The FDA approved Fayuvi, an adeno-associated virus gene therapy given into a vein to treat children with mucopolysaccharidosis type IIIA, also known as Sanfilippo syndrome type A. The one-time therapy uses an AAV9 viral vector to deliver a functional copy of the SGSH gene, allowing patients to produce sulfamidase and break down toxic accumulations of heparan sulfate in the brain.
FDA, also reported by Endpoints News (subscription required)STATFierce PharmaFDA approves Bayer's Kerendia for kidney disease linked to Type 1 diabetes
The FDA granted priority review approval to Bayer's Kerendia, an oral non-steroidal mineralocorticoid receptor antagonist, to slow disease progression in adults with chronic kidney disease linked to Type 1 diabetes.
FDA clears Telix diagnostic Pixclara for brain cancer imaging after prior rejection
The FDA approved Telix Precision Medicine's Pixclara (floretyrosine F-18) for positron emission tomography imaging of gliomas in patients aged one month and older.
FDA introduces pilot program to accelerate early human trials in the US
The FDA unveiled an expedited investigational new drug pilot under its Operation Trialblazer initiative to speed the transition of drug candidates into early clinical testing.
BioPharma Dive, also reported by FDAFierce BiotechFDA approves Bexlutry as first generic copycat of Novartis radioligand Lutathera
The Food and Drug Administration has approved Curium's Bexlutry, clearing the first generic radioligand therapy equivalent to Novartis' Lutathera.
Fierce Pharma, also reported by BioPharma DiveFDA approves Scholar Rock's apitegromab for spinal muscular atrophy
Scholar Rock has secured FDA approval for apitegromab, an injectable monoclonal antibody targeting muscle loss in spinal muscular atrophy.
FDA approves Scholar Rock's Isembyld as first drug targeting SMA muscle loss
The FDA cleared Scholar Rock's myostatin-inhibiting monoclonal antibody Isembyld, also known as apitegromab, for spinal muscular atrophy in patients aged two and older who take SMN2-targeting therapies.
BioPharma Dive, also reported by STAT (subscription required)Fierce PharmaEndpoints News (subscription required)FDA places partial clinical hold on Biohaven's epilepsy drug
The FDA has placed a partial clinical hold pausing enrollment in the RISE-2 trial of opakalim (BHV-7000), an investigational potassium-channel activator for focal epilepsy.
FDA approves Bayer's Hyrnuo for first-line HER2-mutant lung cancer
The FDA has granted first-line approval to Bayer's tyrosine kinase inhibitor Hyrnuo for patients with HER2-mutant non-small cell lung cancer.