Regulatory | 24 October 2026
The company confirmed that it will work closely with the USFDA
These observations are procedural in nature
The approval is based on findings from the ATLAS Phase 3 clinical development programme
Based on I CAN Phase III trial results from prespecified interim analysis in which Ultomiris demonstrated 43.4% reduction in proteinuria vs placebo at 34 weeks
With the approval, Cosentyx becomes the first and only interleukin-17A (IL-17A) inhibitor approved in Europe for adults with PMR
The newly approved regimen offers a chemotherapy-free perioperative approach and is authorised for use across all 27 EU member states
The approval expands the use of Zytorvi beyond its initially approved indication in nasopharyngeal carcinoma (NPC)
Estradiol and Levonorgestrel Transdermal System is primarily used treat moderate to severe symptoms of menopause
The approval was supported by data from Roche’s pivotal Phase III SatraGO programme
Wanbury has commercialised a new Metformin direct-compression (DC) business in Saudi Arabia
The approved ANDA is therapeutically equivalent to the reference listed drug, Ciprodex Otic Suspension (0.3%/0.1%) by Sandoz
Zudus will submit a formal written corrective action plan within the stipulated timelines
The approval paves the way for GenSci to launch CAMCEVI 42 mg in China
Zydus holds exclusive commercialization rights for the United States and Canada and brings extensive commercial experience in the North American market for this product.
The FDA approval is backed by results from the Phase 3 PRIOH-1 trial
European GMP certification validates compliance standards at the Jadcherla finished dosage facility
The company stated it will address the observations comprehensively within the stipulated timeline
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