Novartis’ remibrutinib bags positive CHMP opinion for chronic urticaria

The oral therapy is aimed at adults with chronic spontaneous urticaria (CSU) who do not respond adequately to H1-antihistamines

FDA accepts Roche’s new drug application for Giredestrant in advanced breast cancer

The NDA filing is supported by results from the phase III evERA Breast Cancer study

BridgeBio reports breakthrough results in Phase 3 achondroplasia trial

Achondroplasia is a genetic condition driven by FGFR3 that affects more than stature alone

Roche BTK drug emerges as potential breakthrough in primary progressive MS

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

FDA delays Corcept’s hypertension drug, seeks more evidence

The FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial offered confirmatory evidence

Johnson & Johnson completes $3.05 billion acquisition of Halda Therapeutics

The acquisition adds HLD-0915, a once-daily oral therapy for prostate cancer, to Johnson & Johnson’s nearly 20-year legacy of innovation in the disease

Enveda launches Phase 1 trial for first-in-class Oral IBD therapy

The Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ENV-6946 in healthy volunteers

FDA nod to first oral single-dose treatment for gonorrhea

The approval of Nuzolvence (zoliflodacin) follows a collaborative development effort with the Global Antibiotic Research and Development Partnership

Belite Bio reports landmark phase 3 success for Stargardt Disease therapy

Seeing well-controlled Phase 3 data that shows a marked slowing of lesion growth in Stargardt disease is deeply encouraging