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The agreement aims to advance PrimeGen US’s stem cell research and development and will provide access to public markets capital for progressing clinical studies, regulatory activities, and potential

The designation covers adults with phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-mutant, hormone receptor positive, HR+/HER2- locally advanced or metastatic breast cancer following recurrence or progression after treatment with

Samsung Biologics is set to become part of CEPI’s Vaccine Manufacturing Facility Network (VMFN), aiming to speed up the availability of protein-based vaccines and improve access during outbreaks

The therapy aims to treat Type I allergic reactions, including anaphylaxis, in patients weighing 30kg or more. The CRL highlights deficiencies in human factors validation for Anaphylm, such

The initiative aims to speed up the development of platform-based genetic therapies for rare diseases in the US. It also aims to create a scalable model to deliver

The partnership will focus on creating treatments intended to restore immune homeostasis and deliver durable remission for patients, avoiding the generalised immune suppression associated with existing therapies. Under

This designation aims to expedite the development and review of medicines for serious conditions. The FDA based its decision on comprehensive data, including findings from the Phase II

The partnership will leverage Insilico’s Pharma.AI platform for the development of small molecule inhibitors, with the agreement valued at nearly $120m. This agreement includes development and commercial milestone

The submission relates to patients with mild cognitive impairment or mild dementia due to Alzheimer’s. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date