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

Lilly’s Omvoh shows rapid and lasting relief from bowel urgency in ulcerative colitis patients

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

Roche receives CE mark for novel automated high-throughput Elecsys Dengue Ag test

Test delivers results in just 18 minutes, enabling faster laboratory workflows and patient management during outbreaks

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

AskBio’s gene therapy shows promising 12-month results for heart failure

Results demonstrate favorable safety profile and clinically meaningful improvements in patients with non-ischemic heart failure

MIRA Pharmaceuticals advances oral Ketamir-2 into Phase 1 MAD study for chemotherapy-induced neuropathic pain

Advancing toward Phase 2a evaluation in chemotherapy-related pain, a condition with no approved treatments and potential for FDA Fast Track designation