The tailored framework arrives amid renewed focus on rare diseases across US health agencies.
The tie-up marks the latest pharma company to enlist the AI-powered drug discovery services of Generate.
Anktiva’s newfound FDA label expansion comes as the agency deems cases of CIS and high-grade papillary only NMIBC clinically similar.
Alentis holds an exclusive option to in-license linkers and payloads from PinotBio for incorporation into its pipeline candidates.
Both companies will analyse clinical and biomedical datasets to identify conditions that share the biological mechanisms targeted by XPro.
The new strategy focuses on making the MHRA’s drug and device regulation more efficient and patient centric with the use of technologies like AI.