Fda approval alerts, Over the past two years, Aktis Oncology has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as AKY-1189. Food and Drug Administration has approved drug labeling changes to six menopausal hormone therapy products, also known as hormone replacement therapy (HRT), to clarify risk considerations 5 days ago · Disc Medicine NASDAQ: IRON executives said the company plans to pursue a traditional FDA approval for bitopertin in erythropoietic protoporphyria (EPP) after receiving a Complete Response Letter (CRL) that blocked its accelerated approval application. . Get daily updates on important FDA approval, PDUFA dates, and FDA Advisory Committee Meetings with RTTNews FDA Calendar & Upcoming Approvals. •All News Jul 18, 2025 · FDA Drug Approval Calendar MarketBeat's FDA Calendar tracks confirmed drug approvals, clinical trial results, regulatory decisions, and biotech catalysts — updated daily with real-time stock data. This section contains releases regarding the Food and Drug Administration’s consideration of new products, drugs, therapies and treatments. Has Eli Lilly and Company received FDA approval? Track FDA approvals, PDUFA dates, and regulatory milestones for LLY with the latest event history at MarketBeat. This indication is approved under accelerated approval based on improvement of MASH and fibrosis [see Clinical Studies (14. Feb 12, 2026 · The U. 4)]. Find announcements covering every stage of the FDA application process, from filing to eventual approval, including appeals, resubmissions, and safety alerts. 5 days ago · Aktis Oncology's Drug in the FDA Approval Process This section highlights FDA-related milestones and regulatory updates for drugs developed by Aktis Oncology (AKTS). FDA Calendar Standard FDA Calendar This calendar tracks upcoming PDUFA drug approval dates and FDA advisory committee meetings. S. Continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial. 2 days ago · Has Vaxart received FDA approval? Track FDA approvals, PDUFA dates, and regulatory milestones for VXRT with the latest event history at MarketBeat. Dec 19, 2025 · Archived Alerts and Statements 2010-2015 FDA Archive 2014-2015 FDA Archive 2010-2013 Dec 18, 2025 · FDA Approval FDA Approval The latest news regarding FDA applications, processes, and approval. 2 days ago · Eton Pharmaceuticals announces FDA approval of DESMODA, the first oral liquid desmopressin for central diabetes insipidus management. 3 days ago · Find announcements covering every stage of the FDA application process, from filing to eventual approval, including appeals, resubmissions, and safety alerts.
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