Highlights of recent submissions for approval from the Pink Sheet’s US FDA Performance Tracker

Struggling antibiotic company will go privare under the agreement. Bayer will employ Acuitas's liquid nanoparticle technology in gene therapies developed by subsidiary Asklepios.

Emerging Company Profile: Backed by strong academic talent and a recent $80m fundraising, the US biotech is on a mission to address the unmet medical need in PD-L1 negative cancer by targeting the HHLA2 pathway.

Clinical concerns outweigh quality issues in big pharma CRLs, a Pink Sheet analysis finds, making mirikizumab – the fourth new product candidate sponsored by Lilly to receive a CRL since 2021 – even more of an outlier: it was turned back by FDA because of manufacturing concerns.