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Results For "Food-and-Drug-Administration"

1219 News Found

FDA approves Novavax's Nuvaxovid 2025-2026 formula for prevention of COVID-19
Drug Approval | August 31, 2025

FDA approves Novavax's Nuvaxovid 2025-2026 formula for prevention of COVID-19

Nuvaxovid is the only protein-based, non-mRNA COVID-19 vaccine available in the U.S. for the 2025-2026 vaccination season


Piramal Pharma Solutions supports George Medicines in developing new drug for hypertension
News | August 29, 2025

Piramal Pharma Solutions supports George Medicines in developing new drug for hypertension

WIDAPLIK is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals


Moderna receives FDA approval for updated COVID-19 vaccines for LP.8.1 Variant of SARS-CoV-2
Drug Approval | August 29, 2025

Moderna receives FDA approval for updated COVID-19 vaccines for LP.8.1 Variant of SARS-CoV-2

The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age


Zydus Therapeutics reports positive phase-3 results in rare liver disease
News | August 29, 2025

Zydus Therapeutics reports positive phase-3 results in rare liver disease

Saroglitazar was generally well tolerated, with overall adverse events generally balanced between Saroglitazar-treated and placebo-treated patients


FDA expands Repatha indication to adults at risk of major cardiovascular events from uncontrolled LDL-C
News | August 28, 2025

FDA expands Repatha indication to adults at risk of major cardiovascular events from uncontrolled LDL-C

The FDA also expanded Repatha’s use as monotherapy to include patients with homozygous familial hypercholesterolemia


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


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


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