Johnson & Johnson gets FDA nod for new depression treatment

This approval is based on positive results from two Phase 3, global, double-blind, placebo-controlled trials

Biohaven disappointed as rare disease therapy faces FDA setback 'despite promising results'

The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases

EazeBio and UC Santa Cruz partner to advance instrument-free diagnostic platform

Collaboration aims to deliver rapid, lab-quality testing to communities worldwide – making precision health more accessible

J&J MedTech reports strong one-year results for shockwave peripheral IVL system in DISRUPT BTK II trial

The study demonstrated strong clinical outcomes, with 94.8 per cent of subjects remaining free from major target limb amputation at one year

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

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

FDA grants fast track status to Heidelberg Pharma’s Amanitin-based ADC candidate for multiple myeloma

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