Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 11

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

642 News Found

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


FDA approves Roche’s Tecentriq + lurbinectedin as first-line maintenance therapy for lung cancer
Drug Approval | October 05, 2025

FDA approves Roche’s Tecentriq + lurbinectedin as first-line maintenance therapy for lung cancer

Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase III IMforte study


BMS’s anti-MTBR-Tau granted fast track designation by FDA for Alzheimer’s disease
Drug Approval | October 05, 2025

BMS’s anti-MTBR-Tau granted fast track designation by FDA for Alzheimer’s disease

Anti-microtubule binding region-tau antibody being investigated as a potential disease-modifying therapy to slow or delay progression of disease