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Results For "approval"

2479 News Found

Novo Nordisk to acquire Akero Therapeutics for $5.2 billion
News | October 12, 2025

Novo Nordisk to acquire Akero Therapeutics for $5.2 billion

Acquisition expands Novo Nordisk’s leadership in obesity-related comorbidities and metabolic diseases


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


Lilly’s Omvoh shows sustained 4-year efficacy in ulcerative colitis
News | October 09, 2025

Lilly’s Omvoh shows sustained 4-year efficacy in ulcerative colitis

Lilly's Omvoh is the first and only IL-23p19 antagonist to show four years of sustained, corticosteroid-free comprehensive patient outcomes in ulcerative colitis


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


Briefs: Shilpa Medicare and Medico Remedies
News | October 07, 2025

Briefs: Shilpa Medicare and Medico Remedies

Medico Remedies receives order worth US$ 1,781,000


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


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


Supriya Lifescience’s Ambernath facility receives WHO GMP certification
News | October 04, 2025

Supriya Lifescience’s Ambernath facility receives WHO GMP certification

With global certification in place, the Ambernath site expands Supriya’s footprint beyond APIs into high-margin formulations