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Results For "U.S.-Food-and-Drug-Administration"

579 News Found

FDA grants Fast Track Designation for Teva’s Emrusolmin
Drug Approval | September 09, 2025

FDA grants Fast Track Designation for Teva’s Emrusolmin

Teva received Fast Track designation from the U.S. Food and Drug Administration for emrusolmin (TEV-56286), an investigational treatment for Multiple System Atrophy (MSA) in Phase 2 development


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


Zydus and Synthon ink licensing and supply agreement for Ozanimod Capsules for US market
News | September 05, 2025

Zydus and Synthon ink licensing and supply agreement for Ozanimod Capsules for US market

Under the terms of this agreement, Synthon will be responsible for obtaining final regulatory approval for its Ozanimod Capsules product


FDA completes inspection at Biocon Biologics' facility in Bengaluru
News | September 05, 2025

FDA completes inspection at Biocon Biologics' facility in Bengaluru

The U.S. FDA issued a Form 483 with five observations


FDA expands medtronic MiniMed 780G system
Drug Approval | September 05, 2025

FDA expands medtronic MiniMed 780G system

Now integrates with Abbott’s instinct sensor and approved for type 2 diabetes


FDA grants accelerated approval to Zongertinib for HER2-mutated non-squamous NSCLC
Drug Approval | September 03, 2025

FDA grants accelerated approval to Zongertinib for HER2-mutated non-squamous NSCLC

New targeted therapy offers hope for patients with unresectable or metastatic NSCLC harboring HER2 tyrosine kinase domain activating mutations


FDA approves Lecanemab autoinjector, marking first at-home treatment for Alzheimer disease
Drug Approval | September 02, 2025

FDA approves Lecanemab autoinjector, marking first at-home treatment for Alzheimer disease

The new subcutaneous autoinjector for lecanemab offers a self-administered, at-home treatment option for early-stage Alzheimer's disease


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