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The US FDA has received 510(k) premarket notification for MosaiQ AiPlex Vasculitis (VAS) assay to improve & accelerate diagnosis of Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides & Anti-GBM (Goodpasture's) disease; available in IVDR CE-marking countries…
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Biocytogen has entered into an evaluation & option agreement with Merck KGaA to develop antibody-conjugated lipid-based delivery solutions for nucleic acid payloads, incl. antibody-conjugated lipid nanoparticles
As per the…
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Zenas BioPharma has entered into an agreement with Royalty Pharma granting it royalty rights on the future sales of obexelimab
As per the deal, Zenas will receive ~$300M, consisting…
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Ionis has reported P-III (CORE: n=617 & CORE2: n=446) trials data assessing olezarsen (50 or 80mg, SC, Q4W) vs PBO for 12mos. in adults with severe hypertriglyceridemia (sHTG); the…
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Argo has entered into an additional strategic collaboration with Novartis for multiple CV assets
Novartis has obtained an option to license ex-China rights to two discovery-stage molecules for sHTG…
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Health Canada has approved Elahere under priority review to treat FRα+, Pt-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1-3 prior treatments
Approval was based on P-III…
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ADCs, cell therapies, and radioligand therapies are reshaping oncology, while biopharma companies focus on smarter trials, patient-first approaches, and faster access to bridge unmet needs in cancer care
In…
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The US FDA has accepted NDA of ensitrelvir fumaric acid for the prevention of COVID-19 following exposure to an infected individual (PDUFA: Jun 16, 2026); regulatory review is ongoing in…
