Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
As of Nov 14, 2026, BLA 761385 (Ponlimsi), held by Teva Pharmaceuticals, Inc., was first approved by FDA on Mar 27, 2026, with 1 approved supplement and 1 published complete response letter.
First approved: Mar 27, 2026
Review: Standard
Supplements approved: 1
Complete response letters: 1
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 2 submissions below
Date
Submission
Status
Documents
Mar 27, 2026
Original applicationNew formulation or manufacturer · Standard review
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
