HanchorBio scores first FDA orphan drug tag for gastric cancer therapy

The designation for HCB101covers all forms of gastric cancer, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative patients

FDA nod to Acrotech's new eczema treatment

ADQUEY’s approval opens the door to a new alternative for millions of Americans struggling with atopic dermatitis

Merck’s KEYTRUDA bags FDA nod for platinum-resistant ovarian cancer

KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to its components

Roche BTK drug emerges as potential breakthrough in primary progressive MS

Pfizer’s HYMPAVZI bags FDA priority review, targeting younger & hard-to-treat hemophilia patients

HYMPAVZI is already approved in the US for patients 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors

Bayer’s asundexian demonstrated 26% reduction in stroke after a non-cardioembolic ischemic stroke

These results were consistent across all clinically relevant patient subgroups regardless of key patient characteristics like age or sex, the cause of stroke or the severity of the stroke

Zydus receives FDA’s tentative approval for Dapagliflozin Tablets

Sanofi’s Venglustat shows breakthrough results in rare neurological Gaucher disease

Venglustat, a glucosylceramide synthase inhibitor (GCSi), works by reducing the abnormal buildup of sugar-and-fat molecules in cells and organs

ALX Oncology’s evorpacept shows promise in HER2-positive breast cancer

The findings, based on an exploratory analysis, indicate that CD47 expression may predict which patients benefit most from the therapy

China nod to Darolutamide for metastatic hormone-sensitive prostate cancer

The approval follows the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide plus ADT cut the risk of radiological progression or death by 46% compared to placebo plus ADT