FDA Weekly Report 9/2–9/8: 3 new drug approvals (2 new molecular entities: ZANVASTRO, ETCAMAH)
Drug coverage is FDA approval dates 2026-09-02 to 2026-09-08; 0 efficacy supplements and 8 generic (ANDA) approvals were also recorded.
Reporting period 2026-09-02 to 2026-09-08 (FDA posting-date basis) Published 2026-09-27
Between 2026-09-02 and 2026-09-08, FDA approved 3 new drug applications (NDA/BLA), including 2 new molecular entities, plus 0 efficacy supplements and 8 generics (ANDA). Medical devices cover decision dates 2026-08-17 to 2026-08-28: 116 510(k) clearances, 5 De Novo classifications, and 1 original PMA approval. Drug recalls cover FDA posting dates 2026-08-20 to 2026-09-02 (39 recalls); 2 notable Warning Letters.
This page excerpts a portion of the facts from the full briefing sent weekly to paid members. The complete dataset, violation details, and bilingual FDA approval-letter translations are member-only, as noted in the “Full edition” section below.
Featured briefing — 4 items
IONIS PHARMS INC — ZANVASTRO (ZILGANERSEN)
Approved as a new molecular entity on 2026-09-03 (NDA220210).
ASTRAZENECA PHARMACEUTICALS, LP — ETCAMAH (CAMIZESTRANT)
Approved as a new molecular entity on 2026-09-04 (NDA220359).
HETERO LABS LTD V — IBRUTINIB
India-based sponsor; approved as a generic (ANDA) on 2026-09-08 (ANDA211182).
Xingaoyi Medical Equipment Co., Ltd. — MagicScan-1.5, GreenMR Serenity 1.5T
China-based applicant; 510(k) clearance decided 2026-08-17 (K254250). Device coverage: 2026-08-17 to 2026-08-28.
What the full edition includes
510(k)/De Novo/PMA decisions — 4 of 122 disclosed
| Device | Applicant | Type | Decision date |
|---|---|---|---|
| MagicScan-1.5, GreenMR Serenity 1.5T | Xingaoyi Medical Equipment Co., Ltd. | 510(k) | 2026-08-17 |
| LUOFUCON® Wound Matrix | Huizhou Foryou Medical Devices Co., Ltd. | 510(k) | 2026-08-18 |
| Lancing device | Tianjin Huahong Technology Co., Ltd. | 510(k) | 2026-08-18 |
| BluEX Cervical Expandable Cage System | L&K BIOMED Co., Ltd. | 510(k) | 2026-08-18 |
- All 39 drug recalls — product, reason and classification for every recall
- Full text of 2 Warning Letters — issuing company, cited regulations, and issuing office
- Bilingual FDA approval letters (PDF) — original text and translation side by side, with implications for competitors
- Full FDA dataset (Excel) — structured data including product code, review time, and applicant
On our verification process
No claim without a source
The AI is not permitted to generate claims absent from primary-source text. Where extraction fails, the report states so explicitly rather than filling the gap.
Automated cross-check after generation
Generated text is mechanically checked against the primary source; unsupported statements are automatically flagged and removed.
Key items verified against the original letter
New drug approvals and major efficacy supplements are checked against the actual FDA approval letter before being described.