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Results For "U.S.-Food-and-Drug-Administration"

594 News Found

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


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


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


Merck completes acquisition of Verona Pharma
News | October 07, 2025

Merck completes acquisition of Verona Pharma

Through this acquisition Merck has added Ohtuvayre (ensifentrine) to its growing cardio-pulmonary pipeline and portfolio


TAHO Pharma submits NDA to FDA for world’s first Apixaban oral dissolving film
News | October 06, 2025

TAHO Pharma submits NDA to FDA for world’s first Apixaban oral dissolving film

Pioneering innovation aims to transform anticoagulant therapy and improve patient outcomes


Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection
Drug Approval | October 05, 2025

Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection

The NDA submission follows the successful completion of a pivotal Phase III global clinical trial