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Lupin receives USFDA nod for Famotidine injection
Drug Approval | May 15, 2026

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
Drug Approval | May 15, 2026

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


FDA okays RIVANNA’s AI-powered Accuro XV ultrasound system
Medical Device | May 12, 2026

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
Medical Device | May 11, 2026

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


Biocon Biologics receives 5 procedural observations after US FDA inspection at Bengaluru facility
Biopharma | May 06, 2026

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


Caplin Steriles receives USFDA approval for Calcium Gluconate Injection
Drug Approval | May 06, 2026

Caplin Steriles receives USFDA approval for Calcium Gluconate Injection

Fresenius Kabi's approved generic therapy addresses acute symptomatic hypocalcemia and targets a US market valued at nearly $71 million


Lupin receives USFDA approval for generic Ravicti oral liquid
Drug Approval | May 05, 2026

Lupin receives USFDA approval for generic Ravicti oral liquid

Approval expands Lupin’s specialty portfolio in the US market for treatment of urea cycle disorders


FDA advisory panel narrowly withholds support for AstraZeneca’s combo in breast cancer
News | May 04, 2026

FDA advisory panel narrowly withholds support for AstraZeneca’s combo in breast cancer

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3 to 6 against recommending camizestrant in combination with a CDK4/6 inhibitor