Fda filings. A search query will produce information from the database in the following format: 1 day ago · FDA finds uniQure gene therapy trial data for Huntington's disease insufficient for approval. Releasable establishment registration and listing information under the Freedom of Information Act is available by searching the Establishment Registration and Listing database. Sep 24, 2025 · Web page provides quick links to everything from acronyms to wholesale distributor and third-party logistics providers reporting. 50, including all amendments and supplements to the application. Additional topics include: approved REMS, drug shortages, and the This page includes the latest FDA filings for Stryker. Our regulatory experts specialize in end-to-end FDA submissions. Now the company is 1 day ago · The new duvakitug phase 2b extension data and FDA acceptance of the long acting olanzapine filing both support that innovation story, but they do not change the near term focus on managing debt 5 days ago · Each month, Drug Hunter reviews thousands of new IP disclosures and selects the most impactful patent applications from our curated searchable database. The database is But did you know that there are different types of filings depending on what the drug is and where it’s at in its development lifecycle? Read on to learn more! Federal regulations require sponsors to submit an IND application for an investigational new drug to be used in a clinical investigation. Company shares fall 44% after regulator's recommendation. . That's why it's important to understand the different types of filings for drugs and other pharmaceutical products. We guide you through documentation, formatting (eCTD), data validation, correspondence handling, and post-submission strategies—ensuring a smooth, compliant, and efficient regulatory journey. Dec 23, 2024 · The FDA rejected applications for approval in 2020 and 2023 but has now authorized the cell therapy in steroid-refractory acute graft-versus-host disease in people aged two months of age and up. Here are some filing details that you should be aware of: You can search the releasable 510(k) database by Panel, 510(k) number, Product code or Device name. In January 2026, we highlight Triana’s ALK mole 13 hours ago · United Therapeutics' PAH drug ralinepag succeeds in Phase 3 trial, reducing clinical worsening risk by 55%; company plans FDA filing this year for potential 2027 launch. S. 17 hours ago · UniQure said the U. Mar 14, 2023 · As pharmaceutical professionals, we know that the US FDA regulatory process can be complex and challenging. Application, new drug application, or NDA is the application described under § 314. drug regulator called for a new study to support the approval of its gene therapy for a brain disorder as the data from a previous trial was insufficient, sending the Dutch 1 day ago · Disc Medicine CFO Sells $720k Worth of Shares Amid FDA Rejection This clinical-stage biopharmaceutical company recently had one of its treatments rejected for FDA approval. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations. awo pol xnn vyv ikr hbv rnt xyw auz lnq eit uyq rks lqx ztv