FDA Weekly Report 9/14–9/20: 2 new drug approvals (1 novel CBER biologic: FAYUVI)
Drug coverage is FDA approval dates 2026-09-14 to 2026-09-20; 7 efficacy supplements and 13 generic (ANDA) approvals were also recorded.
Reporting period 2026-09-14 to 2026-09-20 (FDA posting-date basis) Published 2026-09-27
Between 2026-09-14 and 2026-09-20, FDA approved 2 new drug applications (NDA/BLA), including 1 novel CBER biologic, plus 7 efficacy supplements and 13 generics (ANDA). Medical devices cover decision dates 2026-09-07 to 2026-09-13: 70 510(k) clearances and 0 original PMA approvals. Drug recalls cover FDA posting dates 2026-09-10 to 2026-09-16 (4 recalls); 1 notable Warning Letter.
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
Ultragenyx Pharmaceutical Inc — FAYUVI (rebisufligene etisparvovec-hopf)
Licensed on 2026-09-17 as a novel biologic reviewed by CBER (BLA125845).
CIPLA — CALCIUM GLUCONATE IN SODIUM CHLORIDE (CALCIUM GLUCONATE)
India-based sponsor; approved as a generic (ANDA) on 2026-09-17 (ANDA217891).
AUROBINDO PHARMA LTD — CYCLOSPORINE
India-based sponsor; approved as a generic (ANDA) on 2026-09-17 (ANDA219652).
DRTECH Corporation — EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H
South Korea-based applicant; 510(k) clearance decided 2026-09-08 (K260227). Device coverage: 2026-09-07 to 2026-09-13.
What the full edition includes
510(k)/PMA decisions — 4 of 70 disclosed
| Device | Applicant | Type | Decision date |
|---|---|---|---|
| EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H | DRTECH Corporation | 510(k) | 2026-09-08 |
| Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12, GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30) | Zhejiang Geyi Medical Instrument Co., Ltd. | 510(k) | 2026-09-08 |
| Dental Barriers and Sleeves (AB0006) | ANI Co., Ltd. | 510(k) | 2026-09-08 |
| Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 510(k) | 2026-09-09 |
- All 4 drug recalls — product, reason and classification for every recall
- Full text of 1 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
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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.