FDA Drug Approvals Monitor
235
June 2026
Public Health
New drug and biologic approvals granted by the US Food and Drug Administration each month, structured from FDA press announcements, CDER updates, and pharmaceutical news. Each record covers the drug or therapy name, the pharmaceutical company receiving approval, the approved indication, and the approval date. FDA supplemental approvals for significant new indications are included alongside new molecular entity approvals.
FDA drug approvals regulatory decisions
Pharmaceutical investors and biotech analysts use it to monitor competitive approvals and track pipeline-to-market conversion rates. Healthcare providers and formulary teams identify newly approved treatment options through it. Medical affairs and market access teams at pharma companies benchmark approval timelines. Financial journalists covering the biopharma sector use it to report on regulatory milestones.
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<table class="catchall-table"><thead><tr><th style="min-width:40px">#</th><th style="min-width:280px">Event</th><th style="min-width:160px">Decision Date</th><th style="min-width:160px">Drug Name</th><th style="min-width:160px">Indication</th><th style="min-width:160px">Officials Involved</th><th style="min-width:160px">Approval Pathway</th><th style="min-width:160px">Decision Type</th><th style="min-width:160px">Subject Company</th></tr></thead><tbody><tr><td style="min-width:40px">1</td><td style="min-width:280px">UToledo Health offers new Alzheimer's treatment Kisunla</td><td style="min-width:160px">2026-06-01</td><td style="min-width:160px">Kisunla</td><td style="min-width:160px">Alzheimer's disease</td><td style="min-width:160px">Dr. Alina Rais</td><td style="min-width:160px">BLA</td><td style="min-width:160px">full_approval</td><td style="min-width:160px">UToledo Health</td></tr><tr><td style="min-width:40px">2</td><td style="min-width:280px">Novartis plans to seek accelerated approval for del-brax in FSHD</td><td style="min-width:160px">2026-06-01</td><td style="min-width:160px">delpacibart braxlosiran (del-brax)</td><td style="min-width:160px">facioscapulohumeral muscular dystrophy (FSHD)</td><td style="min-width:160px">Vas Narasimhan, M.D.</td><td style="min-width:160px">other</td><td style="min-width:160px">accelerated_approval</td><td style="min-width:160px">Novartis</td></tr><tr><td style="min-width:40px">3</td><td style="min-width:280px">United Therapeutics Plans FDA Submission for Inhaled Treprostinil in IPF</td><td style="min-width:160px">2026-06-16</td><td style="min-width:160px">Tyvaso</td><td style="min-width:160px">idiopathic pulmonary fibrosis</td><td style="min-width:160px">Steven D. Nathan, MD, lead study author on both trials and Schar Chair of the Advanced Lung Disease Program and Lung Transplant Program at Inova Fairfax Hospital</td><td style="min-width:160px">supplement</td><td style="min-width:160px">supplemental_approval</td><td style="min-width:160px">United Therapeutics announced that it plans to submit a supplemental New Drug Application to the FDA for nebulized treprostinil (Tyvaso; United Therapeutics)</td></tr><tr><td style="min-width:40px">4</td><td style="min-width:280px">FDA Approves Bemotrizinol for OTC Sunscreens</td><td style="min-width:160px">2026-06-09</td><td style="min-width:160px">bemotrizinol</td><td style="min-width:160px">active ingredient in over-the-counter sunscreens for sun protection</td><td style="min-width:160px">U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr.</td><td style="min-width:160px">other</td><td style="min-width:160px">full_approval</td><td style="min-width:160px">DSM Nutritional Products LLC</td></tr><tr><td style="min-width:40px">5</td><td style="min-width:280px">FDA Advisory Committee Recommends Moderna Flu Shot</td><td style="min-width:160px">2026-06-18</td><td style="min-width:160px">mFlusiva</td><td style="min-width:160px">influenza in adults aged 50 and older</td><td style="min-width:160px">Dr. Flor Munoz-Rivas; Dr. Anna Durbin; Dr. Timothy Brennan; Dr. Hayley Gans</td><td style="min-width:160px">other</td><td style="min-width:160px">other</td><td style="min-width:160px">Moderna</td></tr><tr class="catchall-blurred"><td>████████████</td><td>████████████</td><td>████████████</td><td>████████████</td><td>████████████</td><td>████████████</td><td>████████████</td><td>████████████</td><td>████████████</td></tr><tr class="catchall-blurred"><td>████████████</td><td>████████████</td><td>████████████</td><td>████████████</td><td>████████████</td><td>████████████</td><td>████████████</td><td>████████████</td><td>████████████</td></tr><tr class="catchall-blurred"><td>████████████</td><td>████████████</td><td>████████████</td><td>████████████</td><td>████████████</td><td>████████████</td><td>████████████</td><td>████████████</td><td>████████████</td></tr></tbody></table>
<h3>Does this include both NME approvals and supplemental approvals for new indications?</h3><p>New molecular entity (NME) and biologics license application (BLA) approvals are the primary focus. Supplemental approvals are included where they represent a significant new treatment option.</p><h3>How does this differ from Drugs@FDA?</h3><p>Drugs@FDA is comprehensive but not structured for bulk analysis. CatchAll extracts the same FDA announcements and structures them with enriched fields – indication category, approval pathway, company, and date – making them easier to filter programmatically.</p><h3>Is May 2026 data available?</h3><p>Yes. The FDA and EMA combined approvals page covers May 2026 and includes EMA approvals alongside FDA.</p><h3>What is the refresh rate of this dataset?</h3><p>We rerun this dataset once a month. You can create your own dataset that updates as frequently as every one hour on <a href="https://platform.newscatcherapi.com/catchall">platform.newscatcherapi.com/catchall</a></p>