FDA and EMA Drug Approvals Monitor
79
September 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.
FDA EMA drug approval new medicine authorized cleared announced
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.
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<div style="overflow-x:auto;width:100%"><table class="catchall-table"><thead><tr><th style="min-width:40px">#</th><th style="min-width:240px">Event</th><th style="min-width:140px;white-space:nowrap">Active Ingredient</th><th style="min-width:140px;white-space:nowrap">Therapeutic Area</th><th style="min-width:140px;white-space:nowrap">Approval Type</th><th style="min-width:140px;white-space:nowrap">Regulatory Agency</th><th style="min-width:140px;white-space:nowrap">Drug Name</th><th style="min-width:140px;white-space:nowrap">Approval Date</th><th style="min-width:140px;white-space:nowrap">Indication Details</th><th style="min-width:140px;white-space:nowrap">Manufacturer Company</th><th style="min-width:120px;white-space:nowrap">Source</th></tr></thead><tbody><tr><td>1</td><td style="min-width:240px">uniQure Submits FDA BLA for Accelerated Approval of AMT-130 for Huntington's Disease</td><td style="min-width:140px">ifezuntirgene inilparvovec</td><td style="min-width:140px">Huntington's disease</td><td style="min-width:140px">Accelerated Approval</td><td style="min-width:140px">FDA</td><td style="min-width:140px">AMT-130</td><td style="min-width:140px">2026-09-02</td><td style="min-width:140px">treatment of Huntington's disease, a rare inherited neurodegenerative disease</td><td style="min-width:140px">UniCure, a Dutch biotechnology company specializing in gene therapy development</td><td style="white-space:nowrap"><a href="https://www.yakup.com/news/index.html?mode=view&pmode=&cat=16&cat2=&cat3=&nid=332044&num_start=0" target="_blank" rel="nofollow">https://www.yakup.com/news/index.html?mode=view&pmode=&cat=16&cat2=&cat3=&nid=332044&num_start=0</a></td></tr><tr><td>2</td><td style="min-width:240px">FDA Approves Revolution Medicines' Rasonque (Daraxonrasib) for Pancreatic Cancer</td><td style="min-width:140px">daraxonrasib</td><td style="min-width:140px">pancreatic cancer</td><td style="min-width:140px">Accelerated Approval</td><td style="min-width:140px">FDA</td><td style="min-width:140px">rasonque</td><td style="min-width:140px">2026-08-26</td><td style="min-width:140px">Treatment of adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not eligible for multidrug systemic therapy</td><td style="min-width:140px">It was developed by the Revolution Medicines statute (currently in the commercialization stage).</td><td style="white-space:nowrap"><a href="https://www.termedia.pl/mz/FDA-zatwierdzila-nowy-lek-na-raka-trzustki,68808.html" target="_blank" rel="nofollow">https://www.termedia.pl/mz/FDA-zatwierdzila-nowy-lek-na-raka-trzustki,68808.html</a></td></tr><tr><td>3</td><td style="min-width:240px">FDA Approves Scholar Rock's Isembild for Spinal Muscular Atrophy</td><td style="min-width:140px">apitegromab</td><td style="min-width:140px">spinal muscular atrophy</td><td style="min-width:140px">Full Approval</td><td style="min-width:140px">FDA</td><td style="min-width:140px">Isembyld</td><td style="min-width:140px">2026-09-11</td><td style="min-width:140px">For pediatric (2 years of age and older) and adult patients with spinal muscular atrophy receiving conventional SMN2-targeted therapy</td><td style="min-width:140px">developed by bio company Scholar Rock</td><td style="white-space:nowrap"><a href="https://www.medipana.com/news/articleView.html?idxno=417925" target="_blank" rel="nofollow">https://www.medipana.com/news/articleView.html?idxno=417925</a></td></tr><tr><td>4</td><td style="min-width:240px">EMA CHMP Recommends Marketing Authorization for Novo Nordisk's Frehemgo</td><td style="min-width:140px">denecimig</td><td style="min-width:140px">hemophilia A</td><td style="min-width:140px">CHMP positive opinion (recommendation for marketing authorization)</td><td style="min-width:140px">EMA</td><td style="min-width:140px">Frehemgo</td><td style="min-width:140px">2026-09-18</td><td style="min-width:140px">Prophylaxis of bleeding episodes in patients with hemophilia A</td><td style="min-width:140px">Frehemgo (denecimig, Novo Nordisk)</td><td style="white-space:nowrap"><a href="https://www.doctor33.it/articolo/68793/farmaci-ema-via-libera-del-chmp-a-12-nuovi-medicinali-le-principali-novita" target="_blank" rel="nofollow">https://www.doctor33.it/articolo/68793/farmaci-ema-via-libera-del-chmp-a-12-nuovi-medicinali-le-principali-novita</a></td></tr><tr><td>5</td><td style="min-width:240px">FDA Approves Eleva Therapeutics' Refictu for Bile Duct Cancer</td><td style="min-width:140px">lirafugratinib</td><td style="min-width:140px">bile duct cancer</td><td style="min-width:140px">Full Approval</td><td style="min-width:140px">FDA</td><td style="min-width:140px">Lyrfigtu</td><td style="min-width:140px">2026-09-23</td><td style="min-width:140px">Second-line treatment for adult patients with locally advanced or metastatic bile duct cancer with FGFR2 gene fusion or rearrangement who have received prior treatment.</td><td style="min-width:140px">HLB's US subsidiary Eleva Therapeutics has been granted US Food and Drug Administration (FDA) permission</td><td style="white-space:nowrap"><a href="https://news.nate.com/view/20260924n10402" target="_blank" rel="nofollow">https://news.nate.com/view/20260924n10402</a></td></tr><tr><td>6</td><td style="min-width:240px">EMA CHMP Issues Positive Opinion Recommending Marketing Authorisation for Sepalna (Senaparib)</td><td style="min-width:140px">senaparib</td><td style="min-width:140px">advanced high-grade epithelial ovarian, fallopian tube and primary peritoneal cancer</td><td style="min-width:140px">Positive opinion (recommendation for marketing authorisation)</td><td style="min-width:140px">EMA</td><td style="min-width:140px">Sepalna</td><td style="min-width:140px">2026-09-17</td><td style="min-width:140px">As first-line maintenance monotherapy for patients with advanced FIGO Stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer who achieved a complete or partial response following platinum-based chemotherapy.</td><td style="min-width:140px">IMPACT Therapeutics and Pharmanovia announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion</td><td style="white-space:nowrap"><a href="https://cgxpwire.com/impact-therapeutics-gains-positive-chmp-opinion-for-senaparib" target="_blank" rel="nofollow">https://cgxpwire.com/impact-therapeutics-gains-positive-chmp-opinion-for-senaparib</a></td></tr><tr><td>7</td><td style="min-width:240px">Roche Granted FDA Priority Review for Enspryng in MOGAD</td><td style="min-width:140px">satralizumab</td><td style="min-width:140px">myelin oligodendrocyte glycoprotein antibody-associated disease</td><td style="min-width:140px">Priority Review</td><td style="min-width:140px">FDA</td><td style="min-width:140px">Enspryng</td><td style="min-width:140px">2026-09-10</td><td style="min-width:140px">Treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) in adults and adolescents aged 12 years or older</td><td style="min-width:140px">Basel, 10 September 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review</td><td style="white-space:nowrap"><a href="https://www.cash.ch/news/roche-fda-pruft-enspryng-fur-seltene-nervenerkrankung-967528" target="_blank" rel="nofollow">https://www.cash.ch/news/roche-fda-pruft-enspryng-fur-seltene-nervenerkrankung-967528</a></td></tr><tr><td>8</td><td style="min-width:240px">FDA Approves Takeda's Orzeyful (oveprexton) for Narcolepsy Type 1</td><td style="min-width:140px">oveporexton</td><td style="min-width:140px">narcolepsy type 1</td><td style="min-width:140px">Priority Review</td><td style="min-width:140px">FDA</td><td style="min-width:140px">Orzeyful</td><td style="min-width:140px">2026-08-05</td><td style="min-width:140px">treatment of narcolepsy type 1 (NT1) in adults</td><td style="min-width:140px">The US FDA has approved oveprexton (Orzeyful, Takeda)</td><td style="white-space:nowrap"><a href="https://www.democrata.es/it/sanita/specialisti-del-sonno-chiedono-il-via-libera-al-primo-farmaco-che-agisce-sulla-causa-della-narcolessia" target="_blank" rel="nofollow">https://www.democrata.es/it/sanita/specialisti-del-sonno-chiedono-il-via-libera-al-primo-farmaco-che-agisce-sulla-causa-della-narcolessia</a></td></tr><tr><td>9</td><td style="min-width:240px">FDA Accepts Takeda's Zasocitinib NDA for Priority Review in Plaque Psoriasis</td><td style="min-width:140px">zasocitinib</td><td style="min-width:140px">plaque psoriasis</td><td style="min-width:140px">Priority Review</td><td style="min-width:140px">FDA</td><td style="min-width:140px">zasocitinib</td><td style="min-width:140px">2026-09-14</td><td style="min-width:140px">for adult patients with moderate to severe plaque psoriasis</td><td style="min-width:140px">Takeda Pharmaceutical Company submitted a new drug approval application for the oral tyrosine kinase 2 inhibitor zasocitinib</td><td style="white-space:nowrap"><a href="https://sport.ftvnews.com.tw/news/detail/2026914W0436" target="_blank" rel="nofollow">https://sport.ftvnews.com.tw/news/detail/2026914W0436</a></td></tr><tr><td>10</td><td style="min-width:240px">FDA Grants Accelerated Approval for Ultragenyx Gene Therapy Genglycos</td><td style="min-width:140px">pariglasgene brecaparvovec-opnr</td><td style="min-width:140px">glycogen storage disease type Ia</td><td style="min-width:140px">Accelerated Approval</td><td style="min-width:140px">FDA</td><td style="min-width:140px">Genglycos</td><td style="min-width:140px">2026-08-19</td><td style="min-width:140px">For patients aged eight and above, contingent upon confirmatory data being provided within two years</td><td style="min-width:140px">Ultragenyx's gene therapy Genglycos</td><td style="white-space:nowrap"><a href="https://biostock.se/en/2026/09/fda-ramps-up-cell-and-gene-therapy-approvals" target="_blank" rel="nofollow">https://biostock.se/en/2026/09/fda-ramps-up-cell-and-gene-therapy-approvals</a></td></tr><tr class="row-locked"><td>11</td><td style="min-width:240px">FDA Approves Eli Lilly's Onswik (insulin efsitora alfa-gobe) for Type 2 Diabetes</td><td style="min-width:140px">insulin efsitora alfa-gobe</td><td style="min-width:140px">type 2 diabetes</td><td style="min-width:140px">Full Approval</td><td style="min-width:140px">FDA</td><td style="min-width:140px">Onswik</td><td style="min-width:140px">2026-09-24</td><td style="min-width:140px">indicated along with diet and exercise to control high blood sugar in adults with type 2 diabetes</td><td style="min-width:140px">Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) approval of Onswik</td><td style="white-space:nowrap"><a href="https://www.worldpharmatoday.com/uncategorized/fda-approves-eli-lillys-once-weekly-basal-insulin-onswik" target="_blank" rel="nofollow">https://www.worldpharmatoday.com/uncategorized/fda-approves-eli-lillys-once-weekly-basal-insulin-onswik</a></td></tr><tr class="row-locked"><td>12</td><td style="min-width:240px">FDA Grants Accelerated Approval for AstraZeneca's Etcamah (camizestrant) in Advanced Breast Cancer</td><td style="min-width:140px">camizestrant</td><td style="min-width:140px">HR-positive, HER2-negative breast cancer</td><td style="min-width:140px">Accelerated Approval</td><td style="min-width:140px">FDA</td><td style="min-width:140px">Etcamah</td><td style="min-width:140px">2026-09-04</td><td style="min-width:140px">Adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer with an ESR1 mutation detected during treatment with an aromatase inhibitor and a CDK4/6 inhibitor</td><td style="min-width:140px">Approval was granted to AstraZeneca.</td><td style="white-space:nowrap"><a href="https://www.yahoo.com/news/science/articles/fda-approves-astrazeneca-etcamah-combo-095539290.html" target="_blank" rel="nofollow">https://www.yahoo.com/news/science/articles/fda-approves-astrazeneca-etcamah-combo-095539290.html</a></td></tr></tbody></table></div>
<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>