FDA grants breakthrough status to Augurex’s SPINEstat test to advance early axSpA diagnosis

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

Novartis to acquire Avidity Biosciences for $12 billion

The acquisition will follow the planned separation of Avidity’s early-stage precision cardiology programs into a new, independent company

Syngene International expands capabilities with new bioconjugation suite in Bengaluru

Bioconjugation capability to complement commercial payload, linker, and monoclonal antibody services

Ipsen to acquire ImCheck Therapeutics to strengthen oncology pipeline

The acquisition centers on ImCheck’s lead Phase I/II program, ICT01, a first-in-class monoclonal antibody targeting BTN3A

Takeda and Innovent Biologics forge global partnership to advance oncology medicines for solid tumors

Takeda will make an upfront payment of $1.2 billion, which includes a $100 million equity investment in Innovent

FDA approves Roche’s kidney inflammation drug

Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study

Johnson & Johnson’s Rybrevant shows 45% response rate in HNSCC

Based on these promising results, Johnson & Johnson plans to move the program into a Phase 3 trial to further investigate subcutaneous amivantamab

Cupid achieves CE (EU IVDR) certification for pregnancy and syphilis test kits