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

Dr. David Berman to Join Moderna as Chief Development Officer

Over a two-decade career, Dr. Berman has worked on more than a dozen clinical-stage immunotherapies, including senior leadership roles in developing four oncology biologics

Shilpa Medicare & mAbTree Biologics win FDA nod for rare blood cancer therapy

The pioneering monoclonal antibody is for Essential Thrombocythemia (ET) and Polycythemia Vera (PV), rare chronic blood cancers with limited treatment options

Insilico Medicine’s AI-designed Parkinson’s drug cleared for human trials by FDA

The upcoming Phase I trial will test the safety, tolerability, and pharmacokinetics of ISM8969 in healthy volunteers and determine the optimal dosing for future studies

Shionogi boosts stake in ViiV Healthcare in $2.125 billion deal, Pfizer exits

Under the deal, ViiV Healthcare will issue new shares to Shionogi for $2.125 billion and cancel Pfizer’s holding

Zydus launches world’s first biosimilar of Nivolumab in India, cutting costs by 75%

Brenig Therapeutics launches first-in-human trial of novel neurodegenerative therapy

The Phase 1 single and multiple ascending dose study is set to begin dosing in early Q1 2026