Drug Approval | February 21, 2026
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
The NDA filing is supported by results from the phase III evERA Breast Cancer study
The results mark a potential breakthrough for patients living with CIndU, a condition with limited treatment options
This approval builds on the recent transformation RYBREVANT FASPRO brought to lung cancer care
The acquisition marks the company’s strategic entry into the fast-growing Hormone Replacement Therapy (HRT) segment and significantly strengthens its gynaecology portfolio in India
DeslaFlex is an innovative antidepressant formulation developed by Spektus using the proprietary Flexitab oral drug-delivery platform
The trial, which compared Retevmo to placebo, met its primary endpoint with a “highly statistically significant and clinically meaningful improvement” in investigator-assessed EFS for patients with stage II–IIIA disease
Alto met its enrollment goal with 83 patients across 13 US clinical sites
Iberdomide has the potential to be the first approved CELMoD agent
Achondroplasia is a genetic condition driven by FGFR3 that affects more than stature alone
Operational leverage kicked in during the quarter, with adjusted EBITDA rising 21% year-on-year to Rs 147 crore
Subscribe To Our Newsletter & Stay Updated
