FDA and EMA Drug Approvals Tracker
294
May 2026
Public Health
Drug and therapy approvals granted by both the US FDA and the European Medicines Agency each month, covering oncology, rare and orphan diseases, immunology, neurology, and other therapeutic areas. Each record includes the drug or therapy name, the pharmaceutical company, the approved indication, the approving authority, approval pathway, and announcement date. CatchAll scanned 4,722 web pages for the May 2026 edition and validated each approval against FDA and EMA regulatory criteria. Conditional marketing authorisations and accelerated approvals are flagged separately.
Pharmaceutical company received FDA or EMA approval for a new drug or therapy in May 2026
Pharmaceutical and biotech investors use it to compare regulatory timelines across the US and EU and track competitive approvals by indication area. Global medical affairs teams coordinate market entry planning across jurisdictions with it. Healthcare economists and HTA bodies monitor the approved drug pipeline. Journalists and analysts covering global pharma use it to report on regulatory activity across both major markets simultaneously.
4722
<table class="catchall-table"><thead><tr><th style="min-width:40px">#</th><th style="min-width:240px">Event</th><th style="min-width:180px">Drug / Therapy Name</th><th style="min-width:180px">Subject Company</th><th style="min-width:130px;white-space:nowrap">Regulatory Agency</th><th style="min-width:300px">Therapeutic Indication</th><th style="min-width:120px;white-space:nowrap">Approval 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:240px">Autobahn Therapeutics' Elunetirom Receives FDA Fast Track Designation for Bipolar Depression</td><td style="min-width:180px">elunetirom</td><td style="min-width:180px">Autobahn Therapeutics</td><td style="min-width:130px;white-space:nowrap">FDA</td><td style="min-width:300px">adjunctive treatment of depressive episodes associated with bipolar I or bipolar II disorder in adults</td><td style="white-space:nowrap">2026-05-26</td><td style="white-space:nowrap"><a href="https://www.eagletribune.com/region/autobahn-therapeutics-announces-u-s-fda-fast-track-designation-for-elunetirom-a-cns-directed-thyroid/article_e08236b3-1dcf-57aa-81cb-cb6a951f820d.html" target="_blank" rel="noopener noreferrer">Source</a></td></tr>
<tr><td style="min-width:40px">2</td><td style="min-width:240px">Pfizer Comirnaty Vaccine Approval and Use in US</td><td style="min-width:180px">Comirnaty</td><td style="min-width:180px">Pfizer</td><td style="min-width:130px;white-space:nowrap">FDA</td><td style="min-width:300px">COVID-19</td><td style="white-space:nowrap">2026-05-01</td><td style="white-space:nowrap"><a href="https://www.ad-hoc-news.de/boerse/news/ueberblick/pfizer-impfstoff-comirnaty-aktuelle-informationen-und-bedeutung-fuer/69301705" target="_blank" rel="noopener noreferrer">Source</a></td></tr>
<tr><td style="min-width:40px">3</td><td style="min-width:240px">FDA Approves First Interchangeable Biosimilars to Simponi and Simponi Aria</td><td style="min-width:180px">Immgolis and Immgolis Intri</td><td style="min-width:180px">Accord BioPharma</td><td style="min-width:130px;white-space:nowrap">FDA</td><td style="min-width:300px">moderately to severely active rheumatoid arthritis (RA) and moderately to severely active ulcerative colitis (UC)</td><td style="white-space:nowrap">2026-05-18</td><td style="white-space:nowrap"><a href="https://www.techbuzz.ai/press-release/PRNewsWire/PRNewsWire-https%3A%2F%2Fwww.prnewswire.com%2Fnews-releases%2Ffda-approves-immgolis-golimumab-sldi-and-immgolis-intri-golimumab-sldi-first-biosimilars-to-simponi-golimumab-and-simponi-aria-golimumab-accord-biopharma-to-lead-us-commercialization-302774328.html" target="_blank" rel="noopener noreferrer">Source</a></td></tr>
<tr><td style="min-width:40px">4</td><td style="min-width:240px">FDA Expands VYVGART Approval for Generalized Myasthenia Gravis</td><td style="min-width:180px">VYVGART</td><td style="min-width:180px">argenx</td><td style="min-width:130px;white-space:nowrap">FDA</td><td style="min-width:300px">all adult patients with generalized myasthenia gravis (gMG)</td><td style="white-space:nowrap">2026-05-08</td><td style="white-space:nowrap"><a href="https://www.phirda.com/artilce_42467.html?module=trackingCodeGenerator" target="_blank" rel="noopener noreferrer">Source</a></td></tr>
<tr><td style="min-width:40px">5</td><td style="min-width:240px">FDA approves TREMFYA label expansion for psoriatic arthritis</td><td style="min-width:180px">TREMFYA</td><td style="min-width:180px">Johnson & Johnson</td><td style="min-width:130px;white-space:nowrap">FDA</td><td style="min-width:300px">inhibition of progression of structural joint damage in adults with active psoriatic arthritis</td><td style="white-space:nowrap">2026-05-28</td><td style="white-space:nowrap"><a href="https://www.zonebourse.com/actualite-bourse/johnson-johnson-obtient-le-feu-vert-de-la-fda-pour-l-extension-d-indication-du-tremfya-a-l-inhibit-ce7f5ddad081f525" target="_blank" rel="noopener noreferrer">Source</a></td></tr>
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<h3>Why track FDA and EMA approvals together?</h3><p>Many drugs are approved in both markets but on different timelines. Tracking both in one place lets pharma teams and investors spot approval gaps and sequence market entry decisions.</p><h3>Are conditional approvals and authorisations under exceptional circumstances included?</h3><p>Yes. EMA conditional marketing authorisations and FDA accelerated approvals are both included and flagged with their approval type.</p><h3>How many approvals are typically included per month?</h3><p>The May 2026 edition covers 72 confirmed approval events across both regulators. Volume varies month to month with regulatory review cycles and PDUFA dates.</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>