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1681 News Found

FDA approves Lecanemab autoinjector, marking first at-home treatment for Alzheimer disease
Drug Approval | September 02, 2025

FDA approves Lecanemab autoinjector, marking first at-home treatment for Alzheimer disease

The new subcutaneous autoinjector for lecanemab offers a self-administered, at-home treatment option for early-stage Alzheimer's disease


Glenmark Pharmaceuticals USA to launch Eribulin Mesylate injection
News | September 02, 2025

Glenmark Pharmaceuticals USA to launch Eribulin Mesylate injection

Glenmark’s Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials is bioequivalent and therapeutically equivalent to the reference listed drug, Halaven Injection, 1 mg/2 mL (0.5 mg/mL),of Eisai


Apitoria Pharma receives 5 observations from USFDA for API facility
Drug Approval | August 31, 2025

Apitoria Pharma receives 5 observations from USFDA for API facility

At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported


FDA suspends Valneva’s license of chikungunya vaccine IXCHIQ in US
Drug Approval | August 31, 2025

FDA suspends Valneva’s license of chikungunya vaccine IXCHIQ in US

The sudden subsequent decision to suspend IXCHIQ is based on updated VAERS data


Novo Nordisk’s Wegovy cuts risk of heart attack, stroke or death by 57% compared to tirzepatide
News | August 31, 2025

Novo Nordisk’s Wegovy cuts risk of heart attack, stroke or death by 57% compared to tirzepatide

The study showed a significant 29% reduction in the risk for heart attack, stroke and death from any cause in the Wegovy users


FDA approves Novavax's Nuvaxovid 2025-2026 formula for prevention of COVID-19
Drug Approval | August 31, 2025

FDA approves Novavax's Nuvaxovid 2025-2026 formula for prevention of COVID-19

Nuvaxovid is the only protein-based, non-mRNA COVID-19 vaccine available in the U.S. for the 2025-2026 vaccination season


Lilly's Verzenio scores first OS improvement in breast Cancer
News | August 30, 2025

Lilly's Verzenio scores first OS improvement in breast Cancer

Treatment with Verzenio also resulted in sustained invasive disease-free survival and distant relapse-free survival benefit


Lilly's oral GLP-1 orforglipron succeeds in Phase 3 trial
News | August 29, 2025

Lilly's oral GLP-1 orforglipron succeeds in Phase 3 trial

Triggering global regulatory submissions this year for the treatment of obesity


Zydus Therapeutics reports positive phase-3 results in rare liver disease
News | August 29, 2025

Zydus Therapeutics reports positive phase-3 results in rare liver disease

Saroglitazar was generally well tolerated, with overall adverse events generally balanced between Saroglitazar-treated and placebo-treated patients


argenx reports positive phase 3 ADAPT SERON results of VYVGART in AChR-Ab seronegative gMG
News | August 28, 2025

argenx reports positive phase 3 ADAPT SERON results of VYVGART in AChR-Ab seronegative gMG

VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications