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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>