Oculis’ Privosegtor wins FDA breakthrough therapy status for Optic Neuritis

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

Shilpa Medicare aims for US approval of chemo nausea drug

Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections

IMCD opens beauty, personal Care laboratory in California

The new facility offers an expanded laboratory alongside meeting areas dedicated to development meetings, formulation workshops, and brainstorming sessions

GSK secures European nod for easier-to-use Shingrix prefilled syringe

The current two-vial format requires healthcare professionals to mix a lyophilised antigen with a liquid adjuvant before administration

GSK reports breakthrough results in chronic hepatitis B trials

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

GSK’s Exdensur wins Japanese nod for severe asthma

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

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

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