BeiGene’s PD-1 Inhibitor Tevimbra Finally Secures FDA Approval
The long-awaited BLA approval for the China-based company’s oncology drug stands out in a week with zero other new drug approvals.
Reporting period 2026-08-20 to 2026-08-26 (FDA posting-date basis) Published 2026-09-05
This week saw a complete halt in new drug and NME approvals, making the BLA for BeiGene’s Tevimbra the singular event in the novel therapeutics space. On the device side, activity remained robust with 65 510(k) clearances and one original PMA approval, while the agency also processed 34 drug recall events.
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
BeiGene’s Tevimbra BLA Approved
The FDA approved BeiGene’s Biologics License Application for tislelizumab-jsgr, a humanized IgG4 anti-PD-1 monoclonal antibody for esophageal squamous cell carcinoma.
Zydus Lifesciences Generic Approved
Zydus Lifesciences received ANDA approval for its Rifabutin capsules, a generic version of the antimycobacterial agent Mycobutin.
Shenzhen Goodwind Eye Device Cleared
The Eye Recovery Pro (PH-e03) from Shenzhen Goodwind Technology Development Co. received 510(k) clearance for over-the-counter use.
Shenzhen Jianchao Hair Remover Cleared
Shenzhen Jianchao Intelligent Technology’s Hair Removal Device (R3C16-G Pro, R3C16-V Pro) was granted 510(k) clearance.
What the full edition includes
510(k)/PMA clearances — 4 of 66 disclosed
| Device | Applicant | Type | Decision date |
|---|---|---|---|
| Eye Recovery Pro (PH-e03) | Shenzhen Goodwind Technology Development Co., Ltd. | 510(k) | 2026-08-10 |
| Hair Removal Device (R3C16-G Pro, R3C16-V Pro) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 510(k) | 2026-08-10 |
| Hemoclip (511 series, 543 series) | Hangzhou AGS MedTech Co., Ltd. | 510(k) | 2026-08-10 |
| Q Switched Nd:YAG Laser machine (QLQW-01) | Beijing Nubway S&T Co., Ltd. | 510(k) | 2026-08-11 |
- All 34 drug recalls — product, reason and classification for every recall
- 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
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