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 Devices2026/06/11 16:24:07

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 Devices2026/06/06 06:38:20

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 Devices2026/05/30 06:28:56

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 Devices2026/05/23 06:25:05

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 Devices2026/05/18 00:56:40

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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