FDA Drug Approvals — July 2026
188
July 2026
Public Health
A structured record of 188 drug approvals issued by the US Food and Drug Administration in July 2026, covering new molecular entities, biologics, breakthrough therapy designations resulting in approval, and OTC switches. Each event captures the approved drug, manufacturer, therapeutic indication, approval pathway, and any key label conditions. Coverage spans all FDA drug and biological product approval actions for the month.
FDA drug approvals regulatory decisions
Pharmaceutical and biotech equity analysts use FDA approval decisions as direct valuation catalysts for pipeline-stage companies. Regulatory affairs professionals at drug developers track approvals to benchmark review timelines and inform their own submission strategies. Healthcare investors, corporate development teams, and pharma licensing professionals monitor new approvals to identify partnership, licensing, and acquisition opportunities.
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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">Drug Name</th><th style="min-width:140px;white-space:nowrap">Indication</th><th style="min-width:140px;white-space:nowrap">Decision Type</th><th style="min-width:140px;white-space:nowrap">Therapeutic Area</th><th style="min-width:140px;white-space:nowrap">Subject Company</th><th style="min-width:140px;white-space:nowrap">Approval Date</th><th style="min-width:140px;white-space:nowrap">Review Designation</th><th style="min-width:140px;white-space:nowrap">Officials Involved</th><th style="min-width:120px;white-space:nowrap">Source</th></tr></thead><tbody><tr><td>1</td><td style="min-width:240px">FDA Advisory Committee Recommends Against Capricor's DMD Therapy</td><td style="min-width:140px">Deramiocel</td><td style="min-width:140px">DMD-associated cardiomyopathy and the preservation of skeletal muscle function</td><td style="min-width:140px">Advisory Committee Recommendation</td><td style="min-width:140px">Duchenne muscular dystrophy</td><td style="min-width:140px">Capricor Therapeutics</td><td style="min-width:140px">2026-07-29</td><td style="min-width:140px">Orphan Drug</td><td style="min-width:140px">Dr John Teerlink, professor and cardiologist; Janet Turk Wittes, a biostatistician</td><td style="white-space:nowrap"><a href="https://www.yahoo.com/news/science/articles/fda-adcom-shuns-capricor-dmd-120146850.html" target="_blank" rel="nofollow">https://www.yahoo.com/news/science/articles/fda-adcom-shuns-capricor-dmd-120146850.html</a></td></tr><tr><td>2</td><td style="min-width:240px">FDA Agreement on Pediatric Study Plan for AP-SA02</td><td style="min-width:140px">AP-SA02</td><td style="min-width:140px">adjunct treatment of complicated Staphylococcus aureus bacteremia (SAB) in pediatric patients</td><td style="min-width:140px">Other</td><td style="min-width:140px">infectious diseases</td><td style="min-width:140px">Armata Pharmaceuticals, Inc.</td><td style="min-width:140px">2026-07-13</td><td style="min-width:140px">Fast Track</td><td style="min-width:140px"></td><td style="white-space:nowrap"><a href="https://www.rttnews.com/3666380/armata-gets-fda-agreement-on-pediatric-plan-for-ap-sa02-in-sab.aspx" target="_blank" rel="nofollow">https://www.rttnews.com/3666380/armata-gets-fda-agreement-on-pediatric-plan-for-ap-sa02-in-sab.aspx</a></td></tr><tr><td>3</td><td style="min-width:240px">Grünenthal receives FDA Orphan Drug and Rare Pediatric Disease Designations for Tegacorat</td><td style="min-width:140px">Tegacorat</td><td style="min-width:140px">treatment of Duchenne muscular dystrophy (DMD)</td><td style="min-width:140px">Other</td><td style="min-width:140px">Duchenne muscular dystrophy</td><td style="min-width:140px">Grünenthal</td><td style="min-width:140px">2026-07-08</td><td style="min-width:140px">Other</td><td style="min-width:140px"></td><td style="white-space:nowrap"><a href="https://article.wn.com/view/2026/07/08/Grunenthal_receives_FDA_Orphan_Drug_and_Rare_Pediatric_Disea_v" target="_blank" rel="nofollow">https://article.wn.com/view/2026/07/08/Grunenthal_receives_FDA_Orphan_Drug_and_Rare_Pediatric_Disea_v</a></td></tr><tr><td>4</td><td style="min-width:240px">FDA expands Casgevy approval for younger children with sickle cell disease</td><td style="min-width:140px">Casgevy (exagamglogene autotemcel)</td><td style="min-width:140px">patients 2 years and older with either sickle cell disease with recurrent vaso-occlusive crises, or transfusion-dependent beta-thalassemia</td><td style="min-width:140px">Full Approval</td><td style="min-width:140px">Rare diseases</td><td style="min-width:140px">Vertex Pharmaceuticals</td><td style="min-width:140px">2026-07-01</td><td style="min-width:140px"></td><td style="min-width:140px">Dr. Megha Kaushal, acting deputy director of the Office of Therapeutic Products at the FDA's Center for Biologics Evaluation and Research</td><td style="white-space:nowrap"><a href="https://www.medicaldaily.com/casgevy-crispr-sickle-cell-fda-approval-children-age-2-2026-476304" target="_blank" rel="nofollow">https://www.medicaldaily.com/casgevy-crispr-sickle-cell-fda-approval-children-age-2-2026-476304</a></td></tr><tr><td>5</td><td style="min-width:240px">Insilico Medicine's ISM6331 Receives FDA Fast Track Designation for Mesothelioma</td><td style="min-width:140px">ISM6331</td><td style="min-width:140px">treatment of adult patients with unresectable malignant pleural mesothelioma whose disease has progressed on or after prior anti-PD-1 antibody therapy, with or without anti-CTLA-4 therapy, and platinum-based chemotherapy</td><td style="min-width:140px">Other</td><td style="min-width:140px">oncology</td><td style="min-width:140px">Insilico Medicine</td><td style="min-width:140px">2026-07-29</td><td style="min-width:140px">Fast Track</td><td style="min-width:140px"></td><td style="white-space:nowrap"><a href="https://longevity.technology/news/insilicos-ai-designed-cancer-drug-receives-fda-fast-track-status" target="_blank" rel="nofollow">https://longevity.technology/news/insilicos-ai-designed-cancer-drug-receives-fda-fast-track-status</a></td></tr><tr><td>6</td><td style="min-width:240px">Pfizer's Talzenna and Xtandi Receive FDA Priority Review</td><td style="min-width:140px">Talzenna and Xtandi</td><td style="min-width:140px">metastatic castration-sensitive prostate cancer, whose tumors have acquired gene changes known as HRR mutations</td><td style="min-width:140px">Other</td><td style="min-width:140px">oncology</td><td style="min-width:140px">Pfizer</td><td style="min-width:140px">2026-10-01</td><td style="min-width:140px">Priority Review</td><td style="min-width:140px"></td><td style="white-space:nowrap"><a href="https://www.yahoo.com/news/science/articles/pfizers-prostate-cancer-drug-combination-204807114.html" target="_blank" rel="nofollow">https://www.yahoo.com/news/science/articles/pfizers-prostate-cancer-drug-combination-204807114.html</a></td></tr><tr><td>7</td><td style="min-width:240px">FDA Approves GSK's Jideytro for ROS1-Positive NSCLC</td><td style="min-width:140px">Jideytro</td><td style="min-width:140px">for adult patients facing locally advanced or metastatic ROS1 positive non small cell lung cancer who have already undergone treatment with a prior ROS1 kinase inhibitor</td><td style="min-width:140px">Full Approval</td><td style="min-width:140px">ROS1-positive non-small cell lung cancer</td><td style="min-width:140px">GSK</td><td style="min-width:140px">2026-07-22</td><td style="min-width:140px">Breakthrough Therapy</td><td style="min-width:140px"></td><td style="white-space:nowrap"><a href="https://www.onclive.com/view/longer-term-data-help-shape-tki-selection-in-ros1-and-alk-nsclc" target="_blank" rel="nofollow">https://www.onclive.com/view/longer-term-data-help-shape-tki-selection-in-ros1-and-alk-nsclc</a></td></tr><tr><td>8</td><td style="min-width:240px">FDA Accepts NDA for Daraxonrasib in Metastatic Pancreatic Cancer</td><td style="min-width:140px">Daraxonrasib</td><td style="min-width:140px">treatment of patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) harboring G12 mutations</td><td style="min-width:140px">Other</td><td style="min-width:140px">oncology</td><td style="min-width:140px">Revolution Medicines, Inc.</td><td style="min-width:140px">2026-07-22</td><td style="min-width:140px">Breakthrough Therapy</td><td style="min-width:140px"></td><td style="white-space:nowrap"><a href="https://au.finance.yahoo.com/news/european-medicines-agency-expedites-assessment-132300210.html" target="_blank" rel="nofollow">https://au.finance.yahoo.com/news/european-medicines-agency-expedites-assessment-132300210.html</a></td></tr><tr><td>9</td><td style="min-width:240px">FDA Grants Orphan Drug Designation to Enzomenib for ALL</td><td style="min-width:140px">enzomenib (DSP-5336)</td><td style="min-width:140px">treatment of patients with acute lymphoblastic leukemia (ALL)</td><td style="min-width:140px">Other</td><td style="min-width:140px">acute lymphoblastic leukemia</td><td style="min-width:140px">Sumitomo Pharma America, Inc. (SMPA)</td><td style="min-width:140px">2026-07-30</td><td style="min-width:140px">Orphan Drug</td><td style="min-width:140px"></td><td style="white-space:nowrap"><a href="https://www.joplinglobe.com/region/national_business/sumitomo-pharma-america-announces-enzomenib-dsp-5336-receives-fda-orphan-drug-designation-for-treatment-of/article_39296087-e671-520c-b121-6fb446f10272.html" target="_blank" rel="nofollow">https://www.joplinglobe.com/region/national_business/sumitomo-pharma-america-announces-enzomenib-dsp-5336-receives-fda-orphan-drug-designation-for-treatment-of/article_39296087-e671-520c-b121-6fb446f10272.html</a></td></tr><tr><td>10</td><td style="min-width:240px">Biocon's Yesafili Receives FDA Approval and Interchangeable Designation</td><td style="min-width:140px">Yesafili</td><td style="min-width:140px">treatment of diabetic macular edema (DME)</td><td style="min-width:140px">Full Approval</td><td style="min-width:140px">ophthalmology</td><td style="min-width:140px">Biocon Limited</td><td style="min-width:140px">2024-05-01</td><td style="min-width:140px">Other</td><td style="min-width:140px"></td><td style="white-space:nowrap"><a href="https://www.biosimilardevelopment.com/doc/biocon-announces-publication-of-pivotal-clinical-data-supporting-effectiveness-of-yesafili-a-biosimilar-to-eylea-aflibercept-0001" target="_blank" rel="nofollow">https://www.biosimilardevelopment.com/doc/biocon-announces-publication-of-pivotal-clinical-data-supporting-effectiveness-of-yesafili-a-biosimilar-to-eylea-aflibercept-0001</a></td></tr><tr class="row-locked"><td>11</td><td style="min-width:240px">Pfizer prepares regulatory filings for Litfulo in vitiligo</td><td style="min-width:140px">Litfulo</td><td style="min-width:140px">treatment of nonsegmental vitiligo (NSV) in adults</td><td style="min-width:140px">Other</td><td style="min-width:140px">autoimmune diseases</td><td style="min-width:140px">Pfizer is preparing to submit global applications to regulatory agencies. The company aims to secure approval for LITFULO as a new oral systemic therapy for adults living with NSV.</td><td style="min-width:140px">2026-07-30</td><td style="min-width:140px"></td><td style="min-width:140px">Iltefat Hamzavi, M.D., senior staff physician in dermatology at Henry Ford Health and Hamzavi Dermatology Specialists</td><td style="white-space:nowrap"><a href="https://www.benzinga.com/trading-ideas/movers/26/07/60808917/pfizer-prepares-global-regulatory-litfulo-filings-following-skin-pigment-improvements-in-late-stage-trials" target="_blank" rel="nofollow">https://www.benzinga.com/trading-ideas/movers/26/07/60808917/pfizer-prepares-global-regulatory-litfulo-filings-following-skin-pigment-improvements-in-late-stage-trials</a></td></tr><tr class="row-locked"><td>12</td><td style="min-width:240px">Harrow Re-Launches FDA-Approved Biosimilar Byooviz</td><td style="min-width:140px">BYOOVIZ (ranibizumab-nuna)</td><td style="min-width:140px">treatment of patients with neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV)</td><td style="min-width:140px">Other</td><td style="min-width:140px">ophthalmology</td><td style="min-width:140px">Samsung Bioepis Co., Ltd.</td><td style="min-width:140px">2023-10-01</td><td style="min-width:140px">Other</td><td style="min-width:140px"></td><td style="white-space:nowrap"><a href="https://www.visionmonday.com/launchpad/eye-health-1/article/harrow-announces-commercial-launch-of-byooviz-in-the-us" target="_blank" rel="nofollow">https://www.visionmonday.com/launchpad/eye-health-1/article/harrow-announces-commercial-launch-of-byooviz-in-the-us</a></td></tr></tbody></table></div>
<h3>What types of FDA drug approvals are captured?</h3><p>The dataset includes standard approvals, priority review approvals, accelerated approvals, breakthrough therapy designations that result in approval, and fast track approvals issued by the FDA for drugs and biological products.</p><h3>Are over-the-counter (OTC) drug approvals included?</h3><p>Yes, where the FDA formally approves a new OTC drug or switches a prescription drug to OTC status. New OTC monograph approvals are included.</p><h3>Are approval withdrawals or post-market safety actions included?</h3><p>No. The dataset focuses on initial approval decisions. Post-market safety actions, label updates, and market withdrawals after approval are not in scope.</p><h3>How often is this dataset updated?</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>