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Results For "U.S"

1563 News Found

FDA approves Coya Therapeutics’ trial of COYA 302 for ALS
News | August 28, 2025

FDA approves Coya Therapeutics’ trial of COYA 302 for ALS

As part of its partnership with Dr. Reddy’s Laboratories (DRL), FDA acceptance also triggers a $4.2 million milestone payment to Coya


Merck presents new data on cardiovascular disease at ESC Congress 2025
News | August 26, 2025

Merck presents new data on cardiovascular disease at ESC Congress 2025

Merck will share two oral presentations on ASCVD treatment patterns and patient burden


J&J  to invest $2 billion at CDMO Fujifilm’s new hub
News | August 25, 2025

J&J to invest $2 billion at CDMO Fujifilm’s new hub

Investment supports Company’s plans to manufacture the vast majority of advanced medicines in the U.S. to meet the needs of patients in the U.S.


Enanta files patent infringement suit against Pfizer
News | August 25, 2025

Enanta files patent infringement suit against Pfizer

The ‘265 Patent is based on Enanta’s July 2020 patent application describing coronavirus protease inhibitors invented by Enanta scientists


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 approved Dawnzera in US as first and only RNA-targeted prophylactic treatment for hereditary angioedema
Drug Approval | August 24, 2025

FDA approved Dawnzera in US as first and only RNA-targeted prophylactic treatment for hereditary angioedema

Dawnzera demonstrated significant and sustained HAE attack rate reduction and long-term disease control


FDA lifts hold on Rocket Pharma's gene therapy trial
News | August 22, 2025

FDA lifts hold on Rocket Pharma's gene therapy trial

Rocket will also collaborate with investigators to implement an immunomodulatory regimen more closely reflecting that administered in the Phase 1 pediatric cohort


NATCO launches Bosentan Tablets for oral suspension in US with 180-day exclusivity
News | August 21, 2025

NATCO launches Bosentan Tablets for oral suspension in US with 180-day exclusivity

NATCO holds the first-to-file status for this product and will have 180-day generic drug exclusivity


HGM acquires Aideo Technologies for Rs. 14 crore to strengthen AI-powered healthcare services platform
Digitisation | August 21, 2025

HGM acquires Aideo Technologies for Rs. 14 crore to strengthen AI-powered healthcare services platform

This acquisition expands HGM's healthcare platform capabilities in revenue cycle management