FDA Drug Approvals Monitor
605
May 2026
Regulatory
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, approval pathway (standard, priority review, breakthrough therapy, accelerated approval), and the approval date. FDA supplemental approvals for significant new indications are included alongside new molecular entity approvals.
FDA drug approvals regulatory decisions May 2026
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.
44000
<table class="catchall-table"><thead><tr><th style="min-width:40px">#</th><th style="min-width:180px">Drug Name</th><th style="min-width:260px">Indication</th><th style="min-width:140px;white-space:nowrap">Decision Type</th><th style="min-width:180px">Manufacturer</th><th style="min-width:120px;white-space:nowrap">Decision Date</th><th style="min-width:120px;white-space:nowrap">Source</th></tr></thead><tbody>
<tr><td style="min-width:40px">1</td><td style="min-width:180px">AVIM Therapy</td><td style="min-width:260px">uncontrolled hypertension</td><td style="min-width:140px;white-space:nowrap">Breakthrough Designation</td><td style="min-width:180px">Orchestra BioMed Holdings, Inc.</td><td style="white-space:nowrap">2026-05-08</td><td style="white-space:nowrap"><a href="https://www.mychesco.com/a/news/regional/orchestra-biomed-targets-2027-data-for-hypertension-trial" target="_blank" rel="noopener noreferrer">Source</a></td></tr>
<tr><td style="min-width:40px">2</td><td style="min-width:180px">MSC therapy</td><td style="min-width:260px">osteoarthritis in cats and dogs</td><td style="min-width:140px;white-space:nowrap">Other</td><td style="min-width:180px">Gallant</td><td style="white-space:nowrap">2026-05-06</td><td style="white-space:nowrap"><a href="https://www.vettimes.com/news/vets/small-animal-vets/stem-cell-therapy-hope-raised-for-treatment-of-oa-in-cats-and-dogs" target="_blank" rel="noopener noreferrer">Source</a></td></tr>
<tr><td style="min-width:40px">3</td><td style="min-width:180px">ABRYSVO</td><td style="min-width:260px">prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV)</td><td style="min-width:140px;white-space:nowrap">Approval</td><td style="min-width:180px">Pfizer Inc.</td><td style="white-space:nowrap">2026-05-04</td><td style="white-space:nowrap"><a href="https://www.openpr.com/news/4500249/in-depth-examination-of-segments-industry-trends-and-key" target="_blank" rel="noopener noreferrer">Source</a></td></tr>
<tr><td style="min-width:40px">4</td><td style="min-width:180px">Saphnelo autoinjector</td><td style="min-width:260px">systemic lupus</td><td style="min-width:140px;white-space:nowrap">Approval</td><td style="min-width:180px">AstraZeneca</td><td style="white-space:nowrap">2026-05-01</td><td style="white-space:nowrap"><a href="https://www.healio.com/news/dermatology/20260522/pipeline-progress-expanded-therapeutic-toolbox-for-cutaneous-lupus-is-imminent" target="_blank" rel="noopener noreferrer">Source</a></td></tr>
<tr><td style="min-width:40px">5</td><td style="min-width:180px">Immgolis and Immgolis Intri</td><td style="min-width:260px">moderately to severely active rheumatoid arthritis and moderately to severely active ulcerative colitis</td><td style="min-width:140px;white-space:nowrap">Approval</td><td style="min-width:180px">Bio-Thera Solutions</td><td style="white-space:nowrap">2026-05-18</td><td style="white-space:nowrap"><a href="https://www.pharmacytimes.com/view/fda-approves-immgolis-and-immgolis-intri-as-first-biosimilars-to-golimumab-reference-products-for-ra-and-uc" target="_blank" rel="noopener noreferrer">Source</a></td></tr>
<tr class="catchall-blurred"><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></tr>
<tr class="catchall-blurred"><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>