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

Irish medtech firm InVera Medical wins EU nod for breakthrough vein treatment device

GSK India crosses Rs. 1,000 crore mark, key portfolios drive 8.1% topline growth

Launched in August 2025, GSK India’s Oncology business is rapidly gaining momentum

Merck scores FDA nod for TGT drug Pimicotinib, promising new hope for patients

The trial also revealed statistically significant and clinically meaningful gains in key patient-reported outcomes

Diabeloop bags FDA nod for DBLG2, opens US market for automated insulin delivery

The clearance marks a major step in Diabeloop’s ambition to become a central partner for insulin pump manufacturers and expand access to automated insulin delivery in the US market

Lupin and Gan & Lee enter exclusive licensing deal for novel GLP-1 receptor agonist

Lupin has bolstered its diabetes and obesity portfolios by securing an agreement for Bofanglutide, a GLP-1 receptor agonist developed by Gan & Lee Pharmaceuticals

Abbott’s Volt PFA System gets FDA nod

AFib is a progressive condition where timely intervention is critical to disease management and, ultimately, the patient's quality of life

Abbott wins FDA & CE nod for groundbreaking premature infant heart device

The system is intended for some of the tiniest patients—premature infants weighing as little as two pounds

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

Bristol Myers Squibb secures FDA nod for Breyanzi in marginal zone lymphoma

The one-time CAR T cell infusion now becomes the first and only therapy of its kind cleared for this patient population