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Results For "safety"

1230 News Found

Caplin Point announces completion of unannounced USFDA inspection
Drug Approval | August 11, 2024

Caplin Point announces completion of unannounced USFDA inspection

The inspection was concluded with zero observations


Atul Bioscience received EIR from USFDA for Ambernath facility
Drug Approval | August 09, 2024

Atul Bioscience received EIR from USFDA for Ambernath facility

The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations


Sucralose safe to use in small doses; reveals MDRF study
News | August 07, 2024

Sucralose safe to use in small doses; reveals MDRF study

Observes no adverse impact of non-nutritive sweetener (NNS) - sucralose on glycemic markers


Lupin completes  successful Phase 3 trials for Lucentis biosimilar
Biotech | August 06, 2024

Lupin completes successful Phase 3 trials for Lucentis biosimilar

The successful completion of the global Phase 3 trials paves the way to obtain marketing approval in the U.S. and EU


Finerenone meets primary endpoint in Phase III FINEARTS-HF cardiovascular study
Diagnostic Center | August 05, 2024

Finerenone meets primary endpoint in Phase III FINEARTS-HF cardiovascular study

Finerenone significantly reduced the composite of cardiovascular death and total (first and recurrent) heart failure events compared to placebo in addition to usual therapy


AbbVie completes acquisition of Cerevel Therapeutics
News | August 03, 2024

AbbVie completes acquisition of Cerevel Therapeutics

Emraclidine, a potential best-in-class, next-generation antipsychotic, is in trials designed to be registration enabling for schizophrenia


European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion
Drug Approval | August 03, 2024

European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion

Approval is based on data from two Phase III studies in branch and central retinal vein occlusion (RVO) showing early and sustained vision improvements non-inferior to aflibercept


Bayer submits NDA to USFDA for elinzanetant for the treatment of VMS associated with menopause
Drug Approval | August 01, 2024

Bayer submits NDA to USFDA for elinzanetant for the treatment of VMS associated with menopause

The New Drug Application (NDA) includes data from the Phase III studies OASIS 1, 2 and 3 - showing elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms over 12 weeks compared to placebo


Fischer MVL and Bio Angle Vacs partner to launch livestock and aquaculture vaccines to India
News | July 31, 2024

Fischer MVL and Bio Angle Vacs partner to launch livestock and aquaculture vaccines to India

BAV has revolutionized the animal vaccination industry with its ground-breaking delivery methods that prioritize quality, safety, and efficacy