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Results For "Food-and-Drug-Administration"

1255 News Found

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


Lupin launches partnership program to expand global reach of PrecisionSphere injectable platform
News | October 09, 2025

Lupin launches partnership program to expand global reach of PrecisionSphere injectable platform

Lupin's partnership program is designed to foster collaborations with companies looking to extend their product lifecycles


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


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