FDA and EMA Drug Approvals Tracker
291
June 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, 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 June 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.
3658
<table class="catchall-table"><thead><tr><th style="min-width:40px">#</th><th style="min-width:280px">Event</th><th style="min-width:160px">Approved Company</th><th style="min-width:160px">Approval Date</th><th style="min-width:160px">Drug Name</th><th style="min-width:160px">Approval Agency</th><th style="min-width:160px">Drug Type</th><th style="min-width:160px">Indication</th><th style="min-width:160px">Approval Type</th></tr></thead><tbody><tr><td style="min-width:40px">1</td><td style="min-width:280px">FDA Clears Solius Pro UVB Light Therapy Device</td><td style="min-width:160px">Solius</td><td style="min-width:160px">2026-06-17</td><td style="min-width:160px">Solius Pro</td><td style="min-width:160px">FDA</td><td style="min-width:160px">UVB light therapy device</td><td style="min-width:160px">stimulate the production of vitamin D in individuals aged 22 years and older</td><td style="min-width:160px">Other</td></tr><tr><td style="min-width:40px">2</td><td style="min-width:280px">Cellectis' lasme-cel receives FDA RMAT designation</td><td style="min-width:160px">Cellectis</td><td style="min-width:160px">2026-06-10</td><td style="min-width:160px">lasme-cel</td><td style="min-width:160px">FDA</td><td style="min-width:160px">CD22-targeted bacterial CAR-T cytotoxicity method</td><td style="min-width:160px">refractory or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)</td><td style="min-width:160px">Other</td></tr><tr><td style="min-width:40px">3</td><td style="min-width:280px">Precigen Receives FDA Orphan Drug Exclusivity for PAPZIMEOS</td><td style="min-width:160px">Precigen</td><td style="min-width:160px">2026-06-15</td><td style="min-width:160px">PAPZIMEOS</td><td style="min-width:160px">FDA</td><td style="min-width:160px">modified adenoviral vector</td><td style="min-width:160px">recurrent respiratory papillomatosis (RRP) in adults</td><td style="min-width:160px">Other</td></tr><tr><td style="min-width:40px">4</td><td style="min-width:280px">Concord Biotech receives USFDA approval for Mycophenolate Mofetil</td><td style="min-width:160px">Concord Biotech</td><td style="min-width:160px">2026-06-01</td><td style="min-width:160px">Mycophenolate Mofetil</td><td style="min-width:160px">FDA</td><td style="min-width:160px">antimetabolite immunosuppressant</td><td style="min-width:160px">prevention of organ rejection in adult and paediatric patients aged three months and above</td><td style="min-width:160px">Other</td></tr><tr><td style="min-width:40px">5</td><td style="min-width:280px">Penumbra Receives FDA Clearance for THUNDERBOLT Device</td><td style="min-width:160px">Penumbra, Inc.</td><td style="min-width:160px">2026-06-08</td><td style="min-width:160px">THUNDERBOLT</td><td style="min-width:160px">FDA</td><td style="min-width:160px">computer assisted vacuum thrombectomy device</td><td style="min-width:160px">acute ischemic stroke</td><td style="min-width:160px">Other</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>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 294 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>