EU nod to Wayrilz as breakthrough treatment for hard-to-treat ITP

Wayrilz represents a new approach to ITP by targeting the disease at its root through multi-immune modulation

Amneal and mAbxience score FDA green light for two Denosumab biosimilars

Soligenix publishes promising Phase 2a data for SGX945 in Behcet's Disease

SGX945 delivered beneficial effects in 7 of 8 patients suffering from painful oral ulcers

Lupin signs exclusive licensing pact with Neopharmed for Plasil in Philippines and Brazil

This agreement will enhance Lupin’s gastroenterology portfolio and expand its presence in emerging markets

Immunome’s Varegacestat shows dramatic results in Phase 3 desmoid tumor trial

The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival

Novo Nordisk files FDA application for once-weekly obesity drug CagriSema

If cleared by regulators, CagriSema would become the first treatment to combine a GLP-1 receptor agonist and a long-acting amylin analogue in a single injection

Pfizer’s TUKYSA shows major benefit in first-line maintenance for metastatic breast cancer

The Phase 3 HER2CLIMB-05 trial showed a 35.9% reduction in risk for patients treated with TUKYSA

MHRA clears inavolisib, offering new option for returning breast cancer

The oral, film-coated tablet is licensed for patients whose cancer has returned during or shortly after hormone therapy

Otsuka files FDA application for first-in-class ADHD drug

Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor

Merck receives EU nod for first subcutaneous formulation, promising faster cancer treatment

This is the first and only subcutaneous immune checkpoint inhibitor available in Europe