FDA rejects Regeneron’s Eylea HD pre-filled syringe application amid manufacturing setbacks

FDA issues warning letter to Philips over manufacturing and quality system deficiencies

The FDA’s review also revealed delays in Philips’ internal investigations, with 54 inquiries failing to meet targeted completion dates—23 of which were delayed by more than 100 days

AbbVie’s RINVOQ shows promise in Vitiligo Phase 3 trials

Vitiligo, affecting over 90 per cent of patients in its non-segmental form, is characterized by symmetrical white patches on both sides of the body

GSK signs $745 million licensing agreement with Empirico for novel respiratory siRNA therapy

The deal reinforces GSK’s leadership in respiratory care and builds upon the company’s expanding COPD portfolio

EU approves Alexion’s Koselugo to treat adults with neurofibromatosis type 1 tumours

Approval based on pivotal KOMET Phase III trial demonstrating significant tumour reduction in adults with NF1

Alexion highlights breakthrough C5 inhibition advances in gMG at 2025 AANEM and MGFA scientific sessions

New Phase III data on gefurulimab highlight potential as a self-administered treatment option; real-world evidence reinforces clinical benefits of Ultomiris and Soliris

RestorixHealth acquires CutisCare to expands wound care portfolio

BMS unveils new data highlighting sustained efficacy and safety of Sotyktu in psoriatic arthritis and lupus

Sotyktu continues to demonstrate consistent efficacy and safety across rheumatic conditions

FDA approves Bayer’s Lynkuet as first hormone-free therapy for menopausal hot flashes

This approval marks a significant milestone in women’s health, introducing Bayer’s first hormone-free treatment for menopause-related symptoms

Elixion Biotech takes quantum-informed R&D route for next-gen precision medicines