Bayer pushes stroke prevention drug forward in China as regulators accept key filing

Stroke is the second-leading cause of death and the third-leading cause of disability worldwide

Teva hits major biosimilar milestones with FDA nod and regulatory filings

The US FDA has approved PONLIMSI (denosumab-adet) as a biosimilar to Prolia

Zydus hits Keytruda biosimilar milestone with successful FYB206 trial, targets USFDA filing

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

Biofrontera scores FDA filing acceptance for Ameluz PDT in skin cancer breakthrough

If approved, Ameluz would become the first and only photodynamic therapy (PDT) photosensitizer for sBCC in the US

Sanofi’s Amlitelimab delivers in Phase 3 trials, heads for global filings

In the SHORE phase 3 study, amlitelimab, used in combination with topical therapies, met all primary and key secondary endpoints at Week 24

Parse Biosciences unveils integrated immune profiling in Trailmaker Platform

The new functionality complements Parse’s existing Evercode immune products

Illumina launches new assay for tumor profiling

he new version features a streamlined sample-to-analysis workflow, built-in HRD detection, faster turnaround, and lower tissue requirements

SeQuent–Viyash merger receives stock exchange approvals; NCLT filing underway

Trimax Biosciences receives CEP Filing submission of Propafenone Hydrochloride from EDQM

Takara Bio Europe unveils new large-scale NGS profiling system and chemistries

The Shasta system and Shasta Whole-Genome Amplification (WGA) Kit dramatically increase throughput for WGA by processing up to 1,500 cells per run