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Results For "United-States"

957 News Found

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


Indian pharma resilient to US tariffs; Eyes US pricing reform gains: Ind-Ra
Policy | August 27, 2025

Indian pharma resilient to US tariffs; Eyes US pricing reform gains: Ind-Ra

The US generic market is crucial for Indian pharma, contributing about 35% to its total revenue, around US$ 10.7 billion


Gland Pharma receives FDA approval for Vasopressin in 5% Dextrose RTU Injection
Drug Approval | August 26, 2025

Gland Pharma receives FDA approval for Vasopressin in 5% Dextrose RTU Injection

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VASOSTRICT Injection 40 Units per 100 mL and 20 Units per 100 mL of PH Health Limited


Roche’s US subsidiary Genentech breaks ground on $700 million manufacturing facility in North Carolina
News | August 26, 2025

Roche’s US subsidiary Genentech breaks ground on $700 million manufacturing facility in North Carolina

The $700 million project is part of Roche’s $50 billion investment in US manufacturing, infrastructure and R&D


FDA grants ODD to Keros KER-065 for treatment of Duchenne muscular dystrophy
Drug Approval | August 25, 2025

FDA grants ODD to Keros KER-065 for treatment of Duchenne muscular dystrophy

KER-065 is a novel ligand trap comprised of a modified ligand-binding domain derived from activin receptor type IIA and activin receptor type IIB


FDA grants breakthrough therapy designation to Ifinatamab Deruxtecan for lung cancer patients
Drug Approval | August 18, 2025

FDA grants breakthrough therapy designation to Ifinatamab Deruxtecan for lung cancer patients

Fourteenth breakthrough therapy designation granted by FDA across the oncology portfolio of Daiichi Sankyo