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1940 News Found

FDA approves Lupin’s Lenalidomide capsules
Drug Approval | September 17, 2025

FDA approves Lupin’s Lenalidomide capsules

Lenalidomide Capsules are indicated for the treatment of adult patients with Multiple myeloma


FDA launches crackdown on deceptive drug advertising
Policy | September 16, 2025

FDA launches crackdown on deceptive drug advertising

The FDA is beginning rulemaking to close the “adequate provision” loophole


FDA grants breakthrough therapy designation to R-DXd for platinum-resistant ovarian and related cancers
Drug Approval | September 16, 2025

FDA grants breakthrough therapy designation to R-DXd for platinum-resistant ovarian and related cancers

Raludotatug deruxtecan is a specifically engineered, potential first-in-class CDH6-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo


Biocartis receives FDA approval for Idylla CDx MSI test
News | September 16, 2025

Biocartis receives FDA approval for Idylla CDx MSI test

First fully automated, cartridge-based companion diagnostic test for colorectal cancer patients approved in the United States


FDA prohibits Sun Pharma's Halol Plant from exporting drugs to US
Drug Approval | September 10, 2025

FDA prohibits Sun Pharma's Halol Plant from exporting drugs to US

Sun Pharma's Halol plant gets OAI classification from US FDA inspection


FDA grants Fast Track Designation for Teva’s Emrusolmin
Drug Approval | September 09, 2025

FDA grants Fast Track Designation for Teva’s Emrusolmin

Teva received Fast Track designation from the U.S. Food and Drug Administration for emrusolmin (TEV-56286), an investigational treatment for Multiple System Atrophy (MSA) in Phase 2 development


USFDA conducts product specific pre-approval inspection at Lupin’s Aurangabad facility
Drug Approval | September 08, 2025

USFDA conducts product specific pre-approval inspection at Lupin’s Aurangabad facility

Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe