Drug Approval | March 31, 2026
Teva hits major biosimilar milestones with FDA nod and regulatory filings
The US FDA has approved PONLIMSI (denosumab-adet) as a biosimilar to Prolia
The US FDA has approved PONLIMSI (denosumab-adet) as a biosimilar to Prolia
Zydus has in-licensed FYB206, a proposed biosimilar to immuno-oncology therapy Keytruda (pembrolizumab), exclusively from Formycon AG for the U.S. and Canadian markets
If approved, Ameluz would become the first and only photodynamic therapy (PDT) photosensitizer for sBCC in the US
In the SHORE phase 3 study, amlitelimab, used in combination with topical therapies, met all primary and key secondary endpoints at Week 24
The new functionality complements Parse’s existing Evercode immune products
he new version features a streamlined sample-to-analysis workflow, built-in HRD detection, faster turnaround, and lower tissue requirements
The Shasta system and Shasta Whole-Genome Amplification (WGA) Kit dramatically increase throughput for WGA by processing up to 1,500 cells per run
The NDA filing for deuruxolitinib with the U.S. FDA is based on two pivotal Phase III trials
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