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This designation is granted for treatments that could significantly improve upon existing options. The FDA’s decision is expected by the fourth quarter of 2025, in line with the

This updated vaccine is aimed at individuals aged six months and older. The CHMP’s endorsement is based on a comprehensive body of evidence, including clinical, non-clinical, and real-world

This approval follows the previous US Food and Drug Administration (FDA) recognitions, including orphan drug and fast track designations awarded in April 2024 and December 2023 to CAN-2409

This steroid-free, topical pan-Janus kinase (JAK) inhibitor is a new option for patients who have not responded adequately to other treatments or cannot use topical corticosteroids. Anzupgo works

Osteoarthritis is a degenerative condition impacting more than 30 million adults in the US. This collaboration will focus on the promotion of Zilretta (triamcinolone acetonide extended-release injectable suspension),

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