Approval based on pivotal KOMET Phase III trial demonstrating significant tumour reduction in adults with NF1
Sotyktu continues to demonstrate consistent efficacy and safety across rheumatic conditions
This approval marks a significant milestone in women’s health, introducing Bayer’s first hormone-free treatment for menopause-related symptoms
The Fast Track Designation was supported by nonclinical data as well as clinical results from the ongoing Phase I/IIa trial evaluating the safety and tolerability
Medherant’s testosterone TEPI Patch could become the first-in-class testosterone patch developed specifically for women
Efdoralprin Alfa was well tolerated, with a safety profile comparable to plasma-derived therapy
Long-term OGSIVEO treatment for up to four years associated with further tumor reductions, increased objective response rate, sustained symptom improvement, and consistent safety profile
Based on these promising results, Johnson & Johnson plans to move the program into a Phase 3 trial to further investigate subcutaneous amivantamab
Vamikibart is the first targeted, non-steroid treatment designed to address the underlying inflammation driving UME
IND clearance enables initiation of Phase 1c clinical trial in HFpEF patients with elevated endotrophin levels
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