BMS Wins Approval for New Molecular Entity Iberdomide as 5 New Drugs Clear FDA
Bristol Myers Squibb’s IBERDOMIDE (ZENBEXUS) led a week of 5 new drug approvals, while India’s Glenmark and Biocon Biologics posted generic and biosimilar approvals. Drug recalls reached 45, including 3 Class I recalls — the FDA’s most severe tier.
Coverage 2026-08-13 to 2026-08-19 (FDA publication basis) · Published 2026-08-29
The FDA approved 5 new drugs this week (4 new molecular entities). Bristol Myers Squibb’s IBERDOMIDE (ZENBEXUS) was approved under NDA 221075 as a Type 1 New Molecular Entity. India’s Glenmark Pharmaceuticals received approval for generic FLUTICASONE PROPIONATE (ANDA 219232), and India’s Biocon Biologics gained approval for its USTEKINUMAB biosimilar YESINTEK (BLA 761406). Drug recalls reached 45, including 3 Class I recalls (the FDA’s most severe classification). Medical device clearances held at 55 510(k)s plus 1 original PMA, with Japan’s Fujifilm Corporation clearing an endoscopy support program.
This page is a partial excerpt from the full briefing we send to paid subscribers each week. The complete recall list, full Warning Letter detail, and the FDA approval-letter collection are member-only, as shown in the “Full Issue” section below.
THIS WEEK’S SPOTLIGHT — 4 ITEMS
Bristol Myers Squibb gains approval for new molecular entity Iberdomide
The FDA approved Bristol Myers Squibb’s IBERDOMIDE (ZENBEXUS) under NDA 221075 as a Type 1 New Molecular Entity.
India’s Glenmark secures generic Fluticasone Propionate approval
Glenmark Pharmaceuticals Ltd received approval for its FLUTICASONE PROPIONATE under Abbreviated New Drug Application (ANDA) 219232.
Biocon Biologics’ Ustekinumab product Yesintek approved
The FDA approved Biocon Biologics Inc.’s USTEKINUMAB (YESINTEK) under Biologics License Application (BLA) 761406.
Three Class I drug recalls this week
Two Cyclophosphamide injection lots manufactured in Taiwan (Sunny Pharmtech Inc., recalled for particulate matter identified as stainless steel) and one lot of Cetirizine tablets manufactured in India (recalled for cross-contamination with another product) were classified Class I — the FDA’s most severe classification, reserved for a reasonable probability of serious harm or death.
WHAT’S IN THE FULL ISSUE
510(k) / PMA Clearances — 4 of 56 shown
| Device | Applicant | Type | Date |
|---|---|---|---|
| EW10-EC02 Endoscopy Support Program | Fujifilm Corporation | 510(k) | 2026-08-07 |
| XLITE | GEMSS Healthcare | 510(k) | 2026-08-03 |
| CAD – Lower GI (EC07-01) | Xiamen Inno Medical | 510(k) | 2026-08-05 |
| Dilight™ Overnight Orthokeratology Lens | Tianjin MasterVision | PMA | 2026-08-05 |
- All 45 drug recalls — including full detail on the 3 Class I recalls and 42 Class II items
- Full text of all 6 Warning Letters — company, cited violation, issuing office
- FDA Official Approval Letter Collection (PDF) — original FDA source documents with strategic commentary
- Full FDA Database (Excel) — Product Code, review timelines, applicant history
ON OUR VERIFICATION PROCESS
This briefing is generated using AI, grounded strictly in FDA primary-source data (openFDA, Federal Register, and FDA.gov). To guard against the “plausible-sounding errors” generative AI can produce, we apply three layers of verification.
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.