FDA Approval: New Drugs & Medical Devices

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Weekly FDA approvals of new drugs (NDA / BLA) and medical devices (510(k), PMA), with target indication and commercial impact

FDA Approval: New Drugs & Medical Devices2026-07-03

FDA approvals: Tregzi leads 8 actions

This week’s FDA approvals digest covers eight actions from June 26 at 5:28 p.m. ET through July 3 at 5:00 p.m. ET, led by Orca Bio’s Tregzi approval and Vertex’s CASGEVY pediatric expansion. The issue also covers Zoryve and Skyrizi pediatric label expansions plus four 510(k) device clearances.

FDA Approval: New Drugs & Medical Devices2026-06-26

FDA approvals: Lumvoa leads 9 actions

This week’s FDA approvals digest covers nine actions from June 19–26, led by Lumvoa and spanning drug expansions, a delivery-device approval, and three 510(k) clearances.

FDA Approval: New Drugs & Medical Devices2026-06-19

FDA approvals week of June 13–19, 2026: first oral carbapenem, two oncology firsts, and a pediatric sweep

Seven FDA actions this week: Utebzi (first oral carbapenem), Ambelvist (lowest-dose GBCA), Welireg+Keytruda (adjuvant ccRCC), Truqap (PTEN-deficient prostate cancer), Tzield Stage 3 T1D, Capvaxive pediatric PCV21, and Dexcom Stelo pediatric CGM.

FDA Approval: New Drugs & Medical Devices2026-06-12

FDA clears Penumbra Thunderbolt CAVT — stroke clearance, June 11 2026

Following Thursday's five-item roundup, this brief mid-week update covers the single FDA 510(k) clearance issued Friday: Penumbra's Thunderbolt, the first computer-assisted vacuum thrombectomy (CAVT) system with modulated aspiration cleared for acute ischemic stroke. The focused analysis covers device mechanism, the 3-year THUNDER IDE trial journey (including the August 2023 FDA-mandated safety endpoint change), competitive context against stent retriever platforms in an ~$830–890M market, and investor signals around the pending $14.5B Boston Scientific acquisition.

FDA Approval: New Drugs & Medical Devices2026-06-11

Five FDA actions in five days: approvals, June 6–11, 2026

Five FDA actions closed the June 6–11 window: Eli Lilly's Ebglyss gained an every-8-week maintenance option for atopic dermatitis — cutting annual injections from 13 to 6; Pfizer's Hympavzi expanded to hemophilia A/B patients ages 6–11 and older patients with inhibitors, becoming the first subcutaneous non-factor therapy for pediatric hemophilia B; Medtronic's Nellcor with Nell-EQ achieved FDA 510(k) clearance with SpO₂ accuracy of 1.33%–1.69% RMS across light, medium, and dark skin tones; and KARL STORZ's Rubina Lens brought NIR/ICG fluorescence imaging to open surgery.

FDA Approval: New Drugs & Medical Devices2026-06-05

Triformis leads a quiet week: FDA approvals, May 29–June 5, 2026

Edwards Lifesciences' Triformis Resilia — the first surgical valve purpose-built for the tricuspid position — anchors a week that also delivered a China-originated IV anesthetic (Cypsedo), a reformulated CML drug solving a key drug-interaction constraint (Cavhanza), and six device clearances spanning AI radiation planning, faster blood culture, handheld OR navigation, automated cardiac AI, and two imaging/fixation platforms.

FDA Approval: New Drugs & Medical Devices2026-05-29

Datroway leads a landmark week: FDA approvals, May 22–29, 2026

Datroway (datopotamab deruxtecan-dlnk) set a new first-line standard of care for immunotherapy-ineligible metastatic TNBC with a 23.7-month median OS — the first agent ever to breach two years in this population. The week also produced the U.S.'s first-ever hepatitis D treatment (Hepcludex), a new BCG-naïve bladder cancer immunotherapy combo (Imfinzi+BCG), AbbVie's first hematology ADC (Decnupaz for ultra-rare BPDCN), pediatric inhaled insulin (Afrezza), and six AI/software device actions.

FDA Approval: New Drugs & Medical Devices2026-05-22

Eight regulatory actions, one dominant sponsor: FDA approvals, May 17–22, 2026

AstraZeneca secured three wins in a single five-day window — Enhertu's dual early breast cancer labels, Baxfendy's first-in-class aldosterone synthase inhibitor, and Fasenra's rare HES expansion — plus a first interchangeable golimumab biosimilar, Trimbow's U.S. debut, a bladder cancer companion diagnostic, a robotic shoulder 510(k), and an Impella safety alert.

FDA Approval: New Drugs & Medical Devices2026-05-17

Four Oncology Drugs and Two Medical Devices Cleared: FDA Approvals, May 10–17, 2026

The FDA cleared four first-in-class or indication-expanding oncology drugs (Beqalzi, Inqovi+venetoclax combo, Tecentriq MRD-guided, Enhertu early-stage) and two novel medical devices during May 10–17, 2026 — with combined peak-sales potential exceeding $8 billion annually.

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