FDA expands Enhertu use in early HER2-positive breast cancer

AstraZeneca highlighted the move as a major step toward earlier intervention in curable disease

FDA grants accelerated approval to BEQALZI for relapsed mantle cell lymphoma

Caplin Steriles receives USFDA approval for generic foscarnet sodium injection

Antiviral injection addressing CMV and HSV infections had US market sales of nearly $15 million in the last 12 months

Lupin receives USFDA nod for Famotidine injection

Famotidine Injection USP is a generic version of Pepcid injection to be manufactured at its Nagpur facility for the U.S. market

Alembic Pharma receives USFDA tentative approval for Darolutamide tablets

Darolutamide Tablets, 300 mg, had an estimated market size of US$ 3,155 million in the United States

Revvity wins FDA clearance for total testosterone test

FDA okays RIVANNA’s AI-powered Accuro XV ultrasound system

The clearance marks a pivotal step forward for the company as it pushes deeper into AI-driven diagnostics and expands its clinical footprint in point-of-care imaging

FDA clears Rivanna’s Accuro XV AI-powered 3D ultrasound system

The ultrasound-based AI imaging platform is designed to support rapid fracture detection and soft tissue injury assessment in emergency care settings

ADMA Biologics wins FDA nod to expand ASCENIV use in young children

Biocon Biologics receives 5 procedural observations after US FDA inspection at Bengaluru facility

The US FDA completed a pre-license inspection of Biocon Biologics’ biosimilars manufacturing site at Biocon Park between April 20 and April 29, 2026