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Results For "FDA"

1939 News Found

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


FDA approves Alembic’s Triamcinolone Acetonide injectable suspension USP, 40 mg/mL
Drug Approval | October 19, 2025

FDA approves Alembic’s Triamcinolone Acetonide injectable suspension USP, 40 mg/mL

Triamcinolone Acetonide injectable suspension USP is indicated for various autoimmune, inflammatory, and other conditions


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


Maverick Simulation installs 3D anatomage table at Safdarjung Hospital
Medical Device | October 14, 2025

Maverick Simulation installs 3D anatomage table at Safdarjung Hospital

The anatomage table is one of the most advanced 3D real-tissue–based anatomy visualization systems in the world


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


FDA approves Teva’s expanded indication for Uzedy for bipolar I disorder
Drug Approval | October 11, 2025

FDA approves Teva’s expanded indication for Uzedy for bipolar I disorder

UZEDY (risperidone) extended-release injectable suspension for subcutaneous use is indicated for use every one or two months for the treatment of schizophrenia in adults


Biocon and Carnegie receive FDA tentative approval for Rifaximin tablets
Drug Approval | October 07, 2025

Biocon and Carnegie receive FDA tentative approval for Rifaximin tablets

Rifaximin tablets are a rifamycin antibacterial indicated for reducing the risk of overt hepatic encephalopathy


FDA approves Zydus’ Deflazacort oral suspension, 22.75 mg/mL
Drug Approval | October 07, 2025

FDA approves Zydus’ Deflazacort oral suspension, 22.75 mg/mL

Deflazacort oral suspension is indicated for treating Duchenne Muscular Dystrophy in patients 5 years of age and older