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Results For "USFDA"

1355 News Found

Zydus receives approval for the name 'Usnoflast' as recommended name for ZYIL1 from WHO  International Non-proprietary Names
News | April 02, 2024

Zydus receives approval for the name 'Usnoflast' as recommended name for ZYIL1 from WHO International Non-proprietary Names

Usnoflast (ZYIL1) is a novel oral small molecule NLRP3 inhibitor discovered at Zydus


Viatris launches RYZUMVl 0.75% in US
News | April 02, 2024

Viatris launches RYZUMVl 0.75% in US

The average time of dilation lasts three to eight hours


AstraZeneca and Daiichi Sankyo’s BLA for Dato-DXd accepted in the US for treatment of breast cancer
Drug Approval | April 02, 2024

AstraZeneca and Daiichi Sankyo’s BLA for Dato-DXd accepted in the US for treatment of breast cancer

Application based on results from the TROPION-Breast01 Phase III trial


FDA Granted ODD to Utidelone Injectable from Biostar Pharma for treatment of breast cancer brain metastasis
Drug Approval | April 01, 2024

FDA Granted ODD to Utidelone Injectable from Biostar Pharma for treatment of breast cancer brain metastasis

Utidelone has the ability to cross BBB due to its unique physicochemical characteristic and insusceptibility to P-glycoprotein-mediated efflux


Krazati monotherapy shows significant survival benefit in KRAS G12C-mutated NSCLC Phase III Krystal -12 data
Drug Approval | April 01, 2024

Krazati monotherapy shows significant survival benefit in KRAS G12C-mutated NSCLC Phase III Krystal -12 data

The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024


Briefs: Alkem Laboratories and Zydus Lifesciences
Drug Approval | March 28, 2024

Briefs: Alkem Laboratories and Zydus Lifesciences

USFDA inspects Zydus Lifesciences’ Ahmedabad SEZ Onco manufacturing plant


Biocon to obtain approval for diabetes drug, Liraglutide in UK
Drug Approval | March 28, 2024

Biocon to obtain approval for diabetes drug, Liraglutide in UK

Liraglutide is a drug-device combination formulation used in the treatment of Type 2 Diabetes Mellitus


Briefs: Concord Biotech and Neuland Laboratories
Drug Approval | March 23, 2024

Briefs: Concord Biotech and Neuland Laboratories

The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483


Briefs: Zydus Lifesciences and Rainbow Children's Medicare
News | March 11, 2024

Briefs: Zydus Lifesciences and Rainbow Children's Medicare

Zydus Lifesciences receives EIR report from USFDA for API Ahmedabad facility