Data indicating unequal treatment effects in women has prompted calls for more nuance in Alzheimer’s diagnosis and drug discovery.

The FDA has approved Zycubo (copper histidinate) injection as the first and only treatment of Menkes disease in pediatric ...

Zycubo received breakthrough therapy, fast track, rare paediatric disease and orphan drug designations from the FDA.

The FDA has accepted a New Drug Application (NDA) for Celcuity’s gedatolisib in hormone receptor positive (HR+), human ...

In July 2025, a class 2 resubmission of tab-cel’s BLA was initiated by Atara Biotherapeutics, developer and sponsor of ...

The pursuit of a cure for Alzheimer's disease is becoming an increasingly competitive and contentious quest, with recent ...

Three years after its initial FDA approval, Roche has made up for an early disadvantage with its blood cancer drug Lunsumio amid competition among CD20xCD3 bispecific antibodies. The FDA has approved ...

Novartis received breakthrough therapy designation from the FDA for ianalumab, a monoclonal antibody aimed at treating Sjögren’s disease. Ianalumab works by depleting B cells and blocking BAFF-R ...

The FDA approved oral semaglutide (Wegovy) for weight loss and reducing major adverse cardiovascular events. Novo Nordisk plans to launch the once-daily oral semaglutide in the US in early January ...

FDA grants Breakthrough Therapy designation to ianalumab for Sjögren disease after the monoclonal antibody showed significant disease improvement.

Amneal Pharmaceuticals re c eived FDA approval for two denosumab biosimilars referencing Prolia and Xgeva. The approval, announced Dec. 22, covers Boncresa (denosumab-mobz) and Oziltus (denosumab-mobz ...

The U.S. Food and Drug Administration on Dec. 22 approved a pill version of Novo Nordisk’s weight-loss drug Wegovy, the first daily oral medication for obesity treatment. The once-daily tablet — ...