Alexion highlights breakthrough C5 inhibition advances in gMG at 2025 AANEM and MGFA scientific sessions

New Phase III data on gefurulimab highlight potential as a self-administered treatment option; real-world evidence reinforces clinical benefits of Ultomiris and Soliris

FDA grants fast track status to Heidelberg Pharma’s Amanitin-based ADC candidate for multiple myeloma

The Fast Track Designation was supported by nonclinical data as well as clinical results from the ongoing Phase I/IIa trial evaluating the safety and tolerability

FDA approves Teva’s expanded indication for Uzedy for bipolar I disorder

UZEDY (risperidone) extended-release injectable suspension for subcutaneous use is indicated for use every one or two months for the treatment of schizophrenia in adults

ACL Digital acquires US-based CRO Symbiance to expand clinical research capabilities

The acquisition positions ACL Digital as an end-to-end provider of global clinical research and data CRO solutions

Biocon Biologics secures US market entry date for Bosaya and Aukelso, Denosumab biosimilars

Moderna’s mNEXSPIKE generates strong immune response against LP.8.1 variant in humans

Both of Moderna's COVID-19 vaccines for the 2025-2026 season have demonstrated strong immune responses against today's top circulating COVID-19 strains

Ascletis reports positive phase Ib results for oral GLP-1R agonist ASC30 at EASD 2025

The Phase Ib MAD study is a randomized, double-blind, placebo-controlled trial conducted in the United States

Biocon Biologics receives FDA approval for Bosaya and Aukelso biosimilars

Lilly launches $1.1 billion TuneLab platform for AI-enabled drug discovery

Program provides access to Lilly-trained artificial intelligence to help accelerate breakthrough medicines

MRM Health raises €55 million Series B to advance microbiome-based biotherapeutic product pipeline

Funding to support Phase 2b trial with MRM Health’s lead program MH002 in ulcerative colitis and advance two additional programs to IND approval