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Rare disease regulation reaches “inflection point” with new FDA framework

The tailored framework arrives amid renewed focus on rare diseases across US health agencies.

Latest news

Zealand Pharma pens $1.2bn AI obesity drug discovery pact with Generate

The tie-up marks the latest pharma company to enlist the AI-powered drug discovery services of Generate.

ImmunityBio’s bladder cancer drug, Anktiva lands US label expansion  

Anktiva’s newfound FDA label expansion comes as the agency deems cases of CIS and high-grade papillary only NMIBC clinically similar.

Alentis and PinotBio partner to develop claudin-1 oncology ADCs

Alentis holds an exclusive option to in-license linkers and payloads from PinotBio for incorporation into its pipeline candidates.

QCi and INmune Bio partner to study XPro in Alzheimer’s

Both companies will analyse clinical and biomedical datasets to identify conditions that share the biological mechanisms targeted by XPro.

MHRA homes in on personalised healthcare and tech in new 2030 strategy

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.