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Results For "U.S"

1563 News Found

AB Science secures US patent for Masitinib in sickle cell disease till 2040
News | December 27, 2025

AB Science secures US patent for Masitinib in sickle cell disease till 2040

Masitinib targets mast cells, which play a critical role in severe forms of SCD and its complications, including vaso-occlusive crises, acute chest syndrome, and pain


FDA okays AQVESME as first treatment for anemia in alpha- & beta-thalassemia
News | December 27, 2025

FDA okays AQVESME as first treatment for anemia in alpha- & beta-thalassemia

The approval makes AQVESME the only FDA-approved therapy for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia


Strides Pharma Inc's Chestnut Ridge facility gets 4 observations from USFDA
Drug Approval | December 26, 2025

Strides Pharma Inc's Chestnut Ridge facility gets 4 observations from USFDA

These observations are procedural in nature and the company does not anticipate any impact on supply of its commercial products


Tanabe Pharma America transfers RADICAVA business to Shionogi
News | December 25, 2025

Tanabe Pharma America transfers RADICAVA business to Shionogi

U.S. and Canada transaction supports continued access to RADICAVA for people living with ALS


Neurocrine’s Valbenazine fails to show benefit in largest dyskinetic cerebral palsy trial
Clinical Trials | December 24, 2025

Neurocrine’s Valbenazine fails to show benefit in largest dyskinetic cerebral palsy trial

Adverse events were consistent with valbenazine’s established safety profile


Bayer wins Japan nod for finerenone in broad heart failure population
Drug Approval | December 23, 2025

Bayer wins Japan nod for finerenone in broad heart failure population

Finerenone is the first therapy targeting the mineralocorticoid receptor pathway to demonstrate cardiovascular benefits in heart failure patients


FDA nod to MYQORZO for obstructive hypertrophic cardiomyopathy
Drug Approval | December 23, 2025

FDA nod to MYQORZO for obstructive hypertrophic cardiomyopathy

The drug is designed to improve functional capacity and reduce symptoms by inhibiting cardiac myosin motor activity


Zydus Partners with Bioeq for US commercialisation rights for Nufymco
News | December 23, 2025

Zydus Partners with Bioeq for US commercialisation rights for Nufymco

NUFYMCO BLA has been approved by the USFDA


GSK strikes deal with US to lower prescription drug costs & boost respiratory medicine access
News | December 22, 2025

GSK strikes deal with US to lower prescription drug costs & boost respiratory medicine access

GSK will make most of its inhaled respiratory portfolio and other products available on a direct purchasing platform, offering savings of up to 66%


Granules receives FDA tentative approval for generic Amphetamine ER orally disintegrating tablets
Drug Approval | December 22, 2025

Granules receives FDA tentative approval for generic Amphetamine ER orally disintegrating tablets

Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia