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The FDA has set a target action date of 6 March 2026. This regulatory step follows similar acceptances in China and Japan, as well as an application validation

This addresses symptomatic, inoperable plexiform neurofibromas (PN) in paediatric and adult patients with neurofibromatosis type 1 (NF1), starting from two years of age. Ezmekly is now the only

This designation is for its use in combination with pertuzumab as a first-line treatment for adult patients with unresectable or metastatic HER2-positive breast cancer. The FDA’s decision was

This expedited process is intended to hasten the development and review of new drugs that address serious conditions with unmet medical needs. The FDA established this procedure to

The company completed a positive Phase IIa trial of the candidate for chronic subjects with peripheral neuropathic pain. It is now preparing for further clinical development and has

Leqselvi is an oral drug that selectively inhibits Janus kinases JAK1 and JAK2. It has been approved for adult patients experiencing severe forms of alopecia areata, an autoimmune

Golden Age Health (GAH) has secured exclusive rights to commercialise and promote Innostellar Biotherapeutics’ first-in-class gene therapy candidate, LX-101, in mainland China. This ten-year Promotional Services Agreement leverages

This partnership will combine the OligoCreator technology of Secarna with Vect-Horus’ VECTrans system. The alliance uses Vect-Horus’ expertise in delivering compounds across biological barriers using its VECTrans platform.

This application aims to secure approval for treating adult and adolescent atopic dermatitis (AD). Under the partnership agreement, Connect Biopharma will receive up to approximately $110m in milestone