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913 News Found

Lonza appoints Jason Berndt as Head of Group Operations
People | September 12, 2025

Lonza appoints Jason Berndt as Head of Group Operations

Maria Soler Nunez appointed as Chief Quality Officer


Gilead Sciences breaks ground on new manufacturing and technical development site in US
News | September 09, 2025

Gilead Sciences breaks ground on new manufacturing and technical development site in US

New Bay Area building marks significant progress as part of $32 billion US investment projected to create $43 billion in economic value


Zydus Lifesciences gets 4 USFDA observations for Jarod Injectable facility
News | September 06, 2025

Zydus Lifesciences gets 4 USFDA observations for Jarod Injectable facility

Zydus will work closely with the USFDA to address and resolve the observations in an expeditious manner


Zydus and Synthon ink licensing and supply agreement for Ozanimod Capsules for US market
News | September 05, 2025

Zydus and Synthon ink licensing and supply agreement for Ozanimod Capsules for US market

Under the terms of this agreement, Synthon will be responsible for obtaining final regulatory approval for its Ozanimod Capsules product


Lupin receives FDA approval for Risperidone LAI with 180-day CGT exclusivity
Drug Approval | September 04, 2025

Lupin receives FDA approval for Risperidone LAI with 180-day CGT exclusivity

This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity


Caplin Steriles granted final approval for ANDA Milrinone Lactate in 5% Dextrose Injection by USFDA
Drug Approval | September 04, 2025

Caplin Steriles granted final approval for ANDA Milrinone Lactate in 5% Dextrose Injection by USFDA

Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure


Zydus Wellness acquires U.K. based Comfort Click for Rs. 2,846 Cr
News | August 31, 2025

Zydus Wellness acquires U.K. based Comfort Click for Rs. 2,846 Cr

Enters the high growth vitamins, minerals and supplements segment for adults, paediatrics, and animal health


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