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HLX22 is the first anti-HER2 targeted treatment to receive ODD from both the US Food and Drug Administration (FDA) in March 2025 and from the EU. An international

This decision marks the injection as the first and only approved continuous delivery treatment by the FDA capable of maintaining vision in DR patients, with a refill required

The funding will enable the company to deliver critical clinical readouts for its core medicine pipeline. Investor M42 spearheaded the funding round, with continued support from current investors.

This partnership will combine Thermo Fisher’s commercial manufacturing offerings and developmental and current good manufacturing practice (cGMP) services with technology platform of Mirai Bio, enhancing the nucleic acid

This ADC, which is currently under assessment in a global Phase Ia/IIb trial, has secured orphan drug designation from the agency for SCLC. According to the company, SCLC

Titled, “Biological Correlative Studies to Improve Current Outcomes of Diffuse Intrinsic Pontine Glioma (DIPG) and High-Risk Brain Tumours with a Neoantigen-Based Anti-Cancer Vaccine in Clinical Trial,” the project is

This marks a step forward in the development of treatments for this incurable paediatric brain tumour. BrainChild Bio noted that a CAR T-cell therapy overcomes the challenges posed

Under the agreement terms, AbbVie will pay ADARx an upfront of $335m, and the latter is also said to be qualified for additional payments. These include option-related fees,

The agency has granted the application priority review, setting a Prescription Drug User Fee Act (PDUFA) target action date of 9 November 2025. The therapy has secured several