FDA Weekly Report 9/9–9/15: 3 new drug approvals (2 new molecular entities: ISEMBYLD, PIXCLARA)
Drug coverage is FDA approval dates 2026-09-09 to 2026-09-15; 4 efficacy supplements and 11 generic (ANDA) approvals were also recorded.
Reporting period 2026-09-09 to 2026-09-15 (FDA posting-date basis) Published 2026-09-27
Between 2026-09-09 and 2026-09-15, FDA approved 3 new drug applications (NDA/BLA), including 2 new molecular entities, plus 4 efficacy supplements and 11 generics (ANDA). Medical devices cover decision dates 2026-08-29 to 2026-09-06: 69 510(k) clearances, 1 De Novo classification, and 0 original PMA approvals. Drug recalls cover FDA posting dates 2026-09-03 to 2026-09-09 (34 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
SCHOLAR ROCK INC — ISEMBYLD (APITEGROMAB-MSTN)
Approved as a new molecular entity on 2026-09-11 (BLA761463).
TELIX PHARMACEUTICALS US INC — PIXCLARA (FLORETYROSINE F 18)
Approved as a new molecular entity on 2026-09-11 (NDA218592).
STRIDES PHARMA — MILNACIPRAN HYDROCHLORIDE
India-based sponsor; approved as a generic (ANDA) on 2026-09-15 (ANDA207399).
Hironic Co., Ltd. — SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)
South Korea-based applicant; 510(k) clearance decided 2026-08-31 (K260387). Device coverage: 2026-08-29 to 2026-09-06.
What the full edition includes
510(k)/De Novo/PMA decisions — 4 of 70 disclosed
| Device | Applicant | Type | Decision date |
|---|---|---|---|
| SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003) | Hironic Co., Ltd. | 510(k) | 2026-08-31 |
| Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907) | Kam Yuen Plastic Products, Ltd. | 510(k) | 2026-08-31 |
| Automatic Digital Blood Pressure monitor (LD-526) | Honsun (Nantong) Co., Ltd. | 510(k) | 2026-08-31 |
| Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) | Guilin Kevin Peter Technology Co., Ltd. | 510(k) | 2026-08-31 |
- All 34 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
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.