Oculis’ Privosegtor wins FDA breakthrough therapy status for Optic Neuritis

The FDA designation follows visual-function results from the Phase 2 ACUITY trial

BeOne Medicines wins first-in-world nod for Sonrotoclax in China

The approval is backed by data showing deep, durable responses and manageable tolerability

World First: Heart bypass without opening the chest achieved by NIH and Emory Team

Breakthrough in PsA: Taltz plus Zepbound show major gains for patients with obesity

This is the first controlled pharmacologic study to demonstrate that treatment of obesity improved PsA disease measures

Ascletis Pharma gets FDA nod for Phase II diabetes trial of oral GLP-1 drug

The trial’s primary endpoint is the mean change in HbA1c from baseline, while secondary endpoints include changes in fasting blood glucose, body weight, and overall safety

Amgen snaps up UK biotech Dark Blue Therapeutics in up to $840m oncology deal

The privately held biotech brings a first-in-class oncology program focused on small molecule–targeted protein degradation

GSK’s Exdensur wins Japanese nod for severe asthma

The approval follows robust data from the SWIFT and ANCHOR Phase III trials

Cellenkos scores FDA orphan drug designation for CK0804 in rare blood cancer

Receiving Orphan Drug Designation is an important milestone in the clinical development of CK0804 for myelofibrosis

Alumis reports breakthrough Phase 3 results for oral psoriasis therapy

The therapy was well tolerated through Week 24, with a safety profile consistent with Alumis’ Phase 2 data

Alzheimer’s could soon be detected with a simple finger-prick

Blood tests measuring biomarkers such as p-tau217 are emerging as accurate, accessible alternatives