Also known as: F.D.A., FDA, Food and Drug Administration, The U.S. Food and Drug Administration, U.S. F.D.A., U.S. FDA, US FDA, USFDA, U.S. Food and Drug Administration (FDA), U.S. Food & Drug Administration, US Food & Drug Administration
WHO set the 2026-2027 northern hemisphere flu vaccine strains. Its FVIVA assessment says improved universal vaccines could prevent 18 billion cases and save 6.2 million lives by 2050.
Citius Oncology reported positive Phase 1 data for LYMPHIR before CAR-T therapy in high-risk DLBCL, showing an 86% overall response rate at one month, and first revenue of $3.9 million from the U.S. launch in CTCL.
AbbVie submitted an FDA NDA for tavapadon, a selective D1/D5 partial agonist for Parkinson's disease, after Phase 3 TEMPO trials showed improved motor scores and more 'on' time. It is a Cerevel asset.
Roche, AstraZeneca, and Eli Lilly announced large biotech licensing deals. The FDA advanced trial and Medicare initiatives, and CRISPR expanded Casgevy's label with CTX611 data due by year-end.
Ricky, 4, became the first patient in New York to receive Otarmeni, a newly FDA-approved gene therapy for otoferlin deafness. Regulators are also advancing frameworks for bespoke gene therapies.
Science and Neurosoft partnered on brain-computer interface technology. Biocytogen licensed a fully human VHH antibody to Qilu Pharmaceutical; MassBio and SCbio selected 10 startups for Drive cohorts.
Clay and Becker leaders reviewed kratom safety without formal action. A Michigan bill would ban growing or selling kratom. FDA has not approved kratom products; North Dakota classifies it as Schedule I.
Inventiva named a new COO ahead of the pivotal Phase III NATiV3 readout of lanifibranor in MASH. Top-line data are due in H2 2026; the trial is fully enrolled with 1,009 patients.
FDA expanded Stelara (ustekinumab) to pediatric ulcerative colitis patients aged 2 years and older. The agency also accepted a vedolizumab sBLA for pediatric UC and Crohn disease, with a PDUFA target date in Q1 2027.
FDA granted roxadustat Orphan Drug Designation for myelodysplastic syndromes. The oral HIF-PH inhibitor improved transfusion independence in a Phase 3 post-hoc analysis.
