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Results For "protein"

511 News Found

FDA approves sBLA for Takeda's Vonvendi for Von Willebrand disease
Drug Approval | September 08, 2025

FDA approves sBLA for Takeda's Vonvendi for Von Willebrand disease

Vonvendi is the only recombinant Von Willebrand factor replacement therapy with approved indications in adults and children with VWD


Merck’s oral PCSK9 inhibitor Enlicitide shows promising results in phase 3 CORALreef lipids study
Clinical Trials | September 04, 2025

Merck’s oral PCSK9 inhibitor Enlicitide shows promising results in phase 3 CORALreef lipids study

Enlicitide achieved all primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful reductions in low-density lipoprotein cholesterol


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


Novo Nordisk taps Replicate Bioscience’s srRNA platform for obesity
News | August 31, 2025

Novo Nordisk taps Replicate Bioscience’s srRNA platform for obesity

Replicate will receive research funding and could potentially receive up to approximately US$550 million


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


Giant antibody in humans acts like a brace against bacterial toxins
News | August 26, 2025

Giant antibody in humans acts like a brace against bacterial toxins

Protein L is known as a “superantigen” because it can bind antibodies in unusual ways


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


AAVantgarde Bio receives FDA fast track designation for AAVB-039 in stargardt disease
Biotech | August 16, 2025

AAVantgarde Bio receives FDA fast track designation for AAVB-039 in stargardt disease

The therapy delivers the full-length ABCA4 protein and has the potential to benefit all patients with ABCA4 mutations


Gland Pharma receives FDA approval for Cangrelor for Injection 50 mg/vial
Drug Approval | August 12, 2025

Gland Pharma receives FDA approval for Cangrelor for Injection 50 mg/vial

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), KENGREAL of Chiesi USA