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Results For "U.S"

1563 News Found

FDA approves Bayer’s Finerenone for new indication in patients with HF and LVEF of ?40%
Drug Approval | July 15, 2025

FDA approves Bayer’s Finerenone for new indication in patients with HF and LVEF of ?40%

Finerenone significantly reduced the combined risk of cardiovascular death and total (first and recurrent) heart failure events,


Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy
News | July 15, 2025

Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy

Capricor’s BLA for Deramiocel received Priority Review in March 2025


Sun Pharma launches LEQSELVI in US for treatment of severe alopecia areata
News | July 14, 2025

Sun Pharma launches LEQSELVI in US for treatment of severe alopecia areata

LEQSELVI now available for prescription in U.S. nationwide, offering a new option for eligible patients


Moderna receives USFDA approval for Covid-19 vaccine ‘Spikevax’
Drug Approval | July 13, 2025

Moderna receives USFDA approval for Covid-19 vaccine ‘Spikevax’

Spikevax is now approved for all individuals aged 6 months through 64 years at increased risk for COVID-19 disease


Pfizer and Astellas' Xtandi combo extends survival in early prostate cancer setting
News | July 11, 2025

Pfizer and Astellas' Xtandi combo extends survival in early prostate cancer setting

Xtandi is approved in over 80 countries, including the U.S., EU, and Japan


Bayer submits EU application for Gadoquatrane MRI contrast agent
News | July 11, 2025

Bayer submits EU application for Gadoquatrane MRI contrast agent

It is intended for contrast enhancement in MRI scans


FDA accepts new drug application for Merck’s Doravirine/Islatravir
Drug Approval | July 11, 2025

FDA accepts new drug application for Merck’s Doravirine/Islatravir

The FDA set a target action date of April 28, 2026, under the Prescription Drug User Fee Act


Merck to acquire Verona Pharma for US$ 10 billion
News | July 10, 2025

Merck to acquire Verona Pharma for US$ 10 billion

Acquisition aligns with Merck’s science-led business development strategy and expands pipeline and portfolio of treatments for cardio-pulmonary diseases