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Results For "Food-and-Drug-Administration"

1255 News Found

FDA grants priority review to Merck’s KEYTRUDA and KEYTRUDA QLEX combos with Padcev for muscle-invasive bladder cancer
Drug Approval | October 23, 2025

FDA grants priority review to Merck’s KEYTRUDA and KEYTRUDA QLEX combos with Padcev for muscle-invasive bladder cancer

The submissions are supported by data from the Phase 3 KEYNOTE-905 trial


FDA approves Roche’s kidney inflammation drug
Drug Approval | October 22, 2025

FDA approves Roche’s kidney inflammation drug

Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study


FDA approves Tezspire for chronic rhinosinusitis with nasal polyps
Drug Approval | October 21, 2025

FDA approves Tezspire for chronic rhinosinusitis with nasal polyps

Approval broadens indication for Tezspire to a second disease characterized by epithelial-driven inflammation


Merck’s DOR/ISL regimen shows minimal impact on weight and lipids in phase 3 HIV studies
Clinical Trials | October 16, 2025

Merck’s DOR/ISL regimen shows minimal impact on weight and lipids in phase 3 HIV studies

These findings follow positive Phase 3 results presented earlier this year


FDA approves AbbVie’s Upadacitinib for treatment of inflammatory bowel disease
Drug Approval | October 14, 2025

FDA approves AbbVie’s Upadacitinib for treatment of inflammatory bowel disease

Updated indication expands treatment options for patients with ulcerative colitis and Crohn’s disease when tumor necrosis factor (TNF) blockers are clinically inadvisable


Roche’s Elecsys pTau181 becomes first FDA-cleared blood test to rule out Alzheimer’s pathology in primary care
R&D | October 14, 2025

Roche’s Elecsys pTau181 becomes first FDA-cleared blood test to rule out Alzheimer’s pathology in primary care

New test expands access to early Alzheimer’s assessment, streamlining diagnostic pathways and improving referral efficiency


Vasa Therapeutics secures FDA IND clearance to advance VS-041 into clinical trial for HFpEF
Drug Approval | October 14, 2025

Vasa Therapeutics secures FDA IND clearance to advance VS-041 into clinical trial for HFpEF

IND clearance enables initiation of Phase 1c clinical trial in HFpEF patients with elevated endotrophin levels


Biocon gets 1 USFDA observation for Cranbury site
Drug Approval | October 14, 2025

Biocon gets 1 USFDA observation for Cranbury site

The Cranbury facility represents a strategic advancement of the company's operations in the Unted States


Merck unveils new HIV treatment and prevention data at EACS 2025
R&D | October 12, 2025

Merck unveils new HIV treatment and prevention data at EACS 2025

Merck will showcase results in innovative solutions in HIV treatment and prevention