FDA and EMA Drug Approvals — July 2026
144
July 2026
Public Health
A structured record of 144 drug and therapy approvals issued by the FDA and European Medicines Agency in July 2026, covering new molecular entities, biologics, biosimilars, and new therapeutic indications for existing drugs. Each event captures the approved drug or therapy, manufacturer, indication, approval type, and review pathway. Coverage spans standard approvals, priority reviews, accelerated approvals, and conditional marketing authorisations.
Pharmaceutical company received FDA or EMA approval for a new drug or therapy in July 2026
Pharmaceutical investment analysts and biotech fund managers use approval data to update pipeline valuation models and identify commercial launch catalysts. Drug pipeline monitoring teams at pharma companies track competitor approvals to assess market entry timing and indication share. Healthcare fund managers and equity research teams use FDA and EMA decisions as high-conviction trading signals in biotech and specialty pharma.
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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">Approval Date</th><th style="min-width:140px;white-space:nowrap">Approval Type</th><th style="min-width:140px;white-space:nowrap">Approval Agency</th><th style="min-width:140px;white-space:nowrap">Subject Company</th><th style="min-width:120px;white-space:nowrap">Source</th></tr></thead><tbody><tr><td>1</td><td style="min-width:240px">Chinese biotech company advances Emergency Use Authorization therapy for Hepatitis Delta in Pakistan</td><td style="min-width:140px">Breakthrough therapy for Hepatitis Delta</td><td style="min-width:140px">Hepatitis Delta</td><td style="min-width:140px">2026-07-01</td><td style="min-width:140px">Emergency Use Authorization</td><td style="min-width:140px">FDA</td><td style="min-width:140px">the Chief Executive Officer of the Chinese biotechnology company developing the therapy visited Pakistan during the B2B Health Conference</td><td style="white-space:nowrap"><a href="https://arynews.tv/pakistan-moves-closer-to-introducing-breakthrough-therapy-for-hepatitis-delta" target="_blank" rel="nofollow">https://arynews.tv/pakistan-moves-closer-to-introducing-breakthrough-therapy-for-hepatitis-delta</a></td></tr><tr><td>2</td><td style="min-width:240px">Cadence Pharmaceuticals Receives FDA Approval for Ofirmev (acetaminophen) Injection</td><td style="min-width:140px">Ofirmev (acetaminophen)</td><td style="min-width:140px">Management of mild to moderate pain; management of moderate to severe pain with adjunctive opioid analgesics; reduction of fever</td><td style="min-width:140px">2026-07-01</td><td style="min-width:140px">Full Approval</td><td style="min-width:140px">FDA</td><td style="min-width:140px">Cadence Pharmaceuticals Announces FDA Approval of Ofirmev (acetaminophen) injection for the Management of Pain and Fever</td><td style="white-space:nowrap"><a href="https://www.drugs.com/newdrugs/cadence-pharmaceuticals-announces-fda-approval-ofirmev-acetaminophen-management-pain-fever-2397.html" target="_blank" rel="nofollow">https://www.drugs.com/newdrugs/cadence-pharmaceuticals-announces-fda-approval-ofirmev-acetaminophen-management-pain-fever-2397.html</a></td></tr><tr><td>3</td><td style="min-width:240px">FDA Approves Ofev (nintedanib) for Idiopathic Pulmonary Fibrosis</td><td style="min-width:140px">Ofev (nintedanib)</td><td style="min-width:140px">Idiopathic Pulmonary Fibrosis</td><td style="min-width:140px">2026-07-01</td><td style="min-width:140px">Full Approval</td><td style="min-width:140px">FDA</td><td style="min-width:140px">Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy designation to nintedanib</td><td style="white-space:nowrap"><a href="https://www.drugs.com/nda/nintedanib_140716.html" target="_blank" rel="nofollow">https://www.drugs.com/nda/nintedanib_140716.html</a></td></tr><tr><td>4</td><td style="min-width:240px">EMA approves Bexatil from Elanco for feline diabetes</td><td style="min-width:140px">Bexatil</td><td style="min-width:140px">reduction of hyperglycemia in cats with diabetes mellitus not previously treated with insulin</td><td style="min-width:140px">2026-07-17</td><td style="min-width:140px">Full Approval</td><td style="min-width:140px">EMA</td><td style="min-width:140px">Elanco</td><td style="white-space:nowrap"><a href="https://www.animalshealth.es/empresas/europa-da-luz-verde-comercializacion-un-nuevo-medicamento-veterinario-este-mes-julio" target="_blank" rel="nofollow">https://www.animalshealth.es/empresas/europa-da-luz-verde-comercializacion-un-nuevo-medicamento-veterinario-este-mes-julio</a></td></tr><tr><td>5</td><td style="min-width:240px">FDA approves Simtriyo for ADHD</td><td style="min-width:140px">Simtriyo (sentanapadine)</td><td style="min-width:140px">attention deficit hyperactivity disorder (ADHD)</td><td style="min-width:140px">2026-07-28</td><td style="min-width:140px">Full Approval</td><td style="min-width:140px">FDA</td><td style="min-width:140px">Otsuka</td><td style="white-space:nowrap"><a href="https://n.news.naver.com/mnews/article/346/0000113485" target="_blank" rel="nofollow">https://n.news.naver.com/mnews/article/346/0000113485</a></td></tr><tr><td>6</td><td style="min-width:240px">Luminopia Receives FDA Clearance for Pediatric Amblyopia Digital Therapeutic in July 2026</td><td style="min-width:140px">Luminopia</td><td style="min-width:140px">improvement in visual acuity in amblyopia patients, aged 4 to <13, associated with anisometropia and/or with mild strabismus</td><td style="min-width:140px">2026-07-01</td><td style="min-width:140px">Full Approval</td><td style="min-width:140px">FDA</td><td style="min-width:140px">Luminopia, Inc., a digital health company pioneering a new class of treatments for neuro-visual disorders, today announced a content licensing agreement with Spin Master Corp., a leading global children's entertainment company, to bring popular children's series to pediatric amblyopia patients using Luminopia's FDA-cleared prescription digital therapeutic.</td><td style="white-space:nowrap"><a href="https://news.nweon.com/141890" target="_blank" rel="nofollow">https://news.nweon.com/141890</a></td></tr><tr><td>7</td><td style="min-width:240px">Teriparatide for Osteoporosis Treatment: Clinical Use and Guidelines</td><td style="min-width:140px">Xinfutai (teriparatide)</td><td style="min-width:140px">osteoporosis in postmenopausal women at high risk of fracture; osteoporosis and glucocorticoid osteoporosis (GIOP) in men at high risk of fractures</td><td style="min-width:140px">2026-07-01</td><td style="min-width:140px">Full Approval</td><td style="min-width:140px">FDA</td><td style="min-width:140px">Xinlitai (Suzhou) Pharmaceutical Co., Ltd</td><td style="white-space:nowrap"><a href="https://m.163.com/dy/article/L31LK8NG0514AE07.html" target="_blank" rel="nofollow">https://m.163.com/dy/article/L31LK8NG0514AE07.html</a></td></tr><tr><td>8</td><td style="min-width:240px">Viatris receives FDA approval for Gwyn Lo contraceptive patch</td><td style="min-width:140px">Gwyn Lo (norelgestromin and ethinyl estradiol)</td><td style="min-width:140px">contraception</td><td style="min-width:140px">2026-07-29</td><td style="min-width:140px">Other</td><td style="min-width:140px">FDA</td><td style="min-width:140px">Viatris Inc.</td><td style="white-space:nowrap"><a href="https://www.finanznachrichten.de/nachrichten-2026-07/69155296-viatris-inc-viatris-receives-u-s-fda-approval-for-gwyn-lo-a-once-weekly-contraceptive-patch-008.htm" target="_blank" rel="nofollow">https://www.finanznachrichten.de/nachrichten-2026-07/69155296-viatris-inc-viatris-receives-u-s-fda-approval-for-gwyn-lo-a-once-weekly-contraceptive-patch-008.htm</a></td></tr><tr><td>9</td><td style="min-width:240px">FDA Approves Cabtreo for Acne Vulgaris Treatment</td><td style="min-width:140px">Cabtreo (clindamycin phosphate, adapalene and benzoyl peroxide)</td><td style="min-width:140px">acne vulgaris</td><td style="min-width:140px">2026-07-01</td><td style="min-width:140px">Full Approval</td><td style="min-width:140px">FDA</td><td style="min-width:140px">FDA Approves Cabtreo (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel for the Treatment of Acne Vulgaris
LAVAL, Quebec, Oct. 20, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) ('Bausch Health') and its dermatology business, Ortho Dermatologics, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for Cabtreo (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, indicated for the topical treatment of acne vulgaris in patients twelve years of age and older.</td><td style="white-space:nowrap"><a href="https://www.drugs.com/newdrugs/fda-approves-cabtreo-clindamycin-phosphate-adapalene-benzoyl-peroxide-topical-gel-acne-vulgaris-6121.html" target="_blank" rel="nofollow">https://www.drugs.com/newdrugs/fda-approves-cabtreo-clindamycin-phosphate-adapalene-benzoyl-peroxide-topical-gel-acne-vulgaris-6121.html</a></td></tr><tr><td>10</td><td style="min-width:240px">Haizheng Pharmaceutical's Fludarabine Phosphate Injection Receives US FDA Approval</td><td style="min-width:140px">Fludarabine phosphate injection</td><td style="min-width:140px">adult B-cell chronic lymphocytic leukemia (CLL); as a component of a combination therapy regimen; for treatment that is refractory to prior treatment with at least one alkylating agent or adult patients with B-cell chronic lymphocytic leukaemia who have had disease progression during treatment</td><td style="min-width:140px">2026-07-24</td><td style="min-width:140px">Full Approval</td><td style="min-width:140px">FDA</td><td style="min-width:140px">Haizheng Pharmaceutical</td><td style="white-space:nowrap"><a href="https://finance.eastmoney.com/a/202607243820476923.html" target="_blank" rel="nofollow">https://finance.eastmoney.com/a/202607243820476923.html</a></td></tr><tr class="row-locked"><td>11</td><td style="min-width:240px">EMA recommends marketing authorization for Zambon's Hopledo for Parkinson's disease</td><td style="min-width:140px">Hopledo (levodopa-carbidopa)</td><td style="min-width:140px">moderate to severe motor fluctuations in patients with Parkinson's disease</td><td style="min-width:140px">2026-07-07</td><td style="min-width:140px">Other</td><td style="min-width:140px">EMA</td><td style="min-width:140px">Zambon SpA</td><td style="white-space:nowrap"><a href="https://francais.medscape.com/viewarticle/nouveau-m%C3%A9dicament-contre-maladie-parkinson-allie-2026a1000m1k" target="_blank" rel="nofollow">https://francais.medscape.com/viewarticle/nouveau-m%C3%A9dicament-contre-maladie-parkinson-allie-2026a1000m1k</a></td></tr><tr class="row-locked"><td>12</td><td style="min-width:240px">FDA Approves Vivjoa for Recurrent Vulvovaginal Candidiasis</td><td style="min-width:140px">Vivjoa (oteseconazole)</td><td style="min-width:140px">Recurrent Vulvovaginal Candidiasis (RVVC); chronic yeast infection</td><td style="min-width:140px">2026-07-19</td><td style="min-width:140px">Full Approval</td><td style="min-width:140px">FDA</td><td style="min-width:140px">Mycovia Pharmaceuticals, Inc.</td><td style="white-space:nowrap"><a href="https://www.drugs.com/newdrugs/fda-approves-vivjoa-oteseconazole-recurrent-vulvovaginal-candidiasis-chronic-yeast-infection-5824.html" target="_blank" rel="nofollow">https://www.drugs.com/newdrugs/fda-approves-vivjoa-oteseconazole-recurrent-vulvovaginal-candidiasis-chronic-yeast-infection-5824.html</a></td></tr></tbody></table></div>
<h3>What types of approvals are covered?</h3><p>The dataset captures full new drug approvals (NDA/BLA by FDA, Marketing Authorisation by EMA), accelerated and conditional approvals, and approvals of biosimilars and new therapeutic indications for existing drugs.</p><h3>Are generic drug approvals included?</h3><p>No. The dataset focuses on novel drug and therapy approvals — new molecular entities, biologics, and new indications. Generic ANDA approvals are excluded.</p><h3>Are approvals in other countries included?</h3><p>Only FDA (US) and EMA (EU) approvals are in scope. Approvals from other national regulators (e.g. MHRA, PMDA, Health Canada) are not captured unless they coincide with an FDA or EMA decision.</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>