Browsing Tag
FDA approval
131 posts
FDA approves first generic liraglutide injection for Type 2 diabetes treatment
In a significant milestone for diabetes care, the U.S. Food and Drug Administration (FDA) has approved the first…
FDA approves Checkpoint Therapeutics’ Unloxcyt for advanced cSCC
Shares of Checkpoint Therapeutics, Inc. rose 4.6% to $3.84 in post-market trading after the US Food and Drug…
FDA approves CRENESSITY: A breakthrough treatment from Neurocrine Biosciences for classic congenital adrenal hyperplasia
Neurocrine Biosciences has announced US Food and Drug Administration (FDA) approval of CRENESSITY, marking a significant milestone in…
DentalMonitoring introduces AI-driven orthodontic update leveraging FDA approval
DentalMonitoring, a global leader in Artificial Intelligence-powered remote orthodontic monitoring, has unveiled a significant software update, bringing advanced…
FDA approves Novocure’s new flexible HFE arrays for glioblastoma treatment
Novocure has received FDA approval for its innovative Head Flexible Electrode (HFE) transducer arrays, designed to enhance the…
FDA approves MedImmune’s nasal spray flu vaccine FluMist
The U.S. Food and Drug Administration has approved FluMist, a nasal spray flu vaccine by MedImmune LLC, for…
Zevra Therapeutics’ MIPLYFFA receives FDA approval as first treatment for Niemann-Pick disease
Zevra Therapeutics Inc. has announced U.S. Food and Drug Administration (FDA) approval of MIPLYFFA (arimoclomol), a capsule-based treatment…
Cancer treatment just got faster: FDA approves Genentech’s Tecentriq Hybreza for quick 7-minute injection
The U.S. Food and Drug Administration (FDA) has granted approval for Tecentriq Hybreza, the first and only PD-(L)1…
Emergent BioSolutions’ ACAM2000 receives FDA approval for Mpox prevention
Emergent BioSolutions Inc. (NYSE: EBS) has achieved a notable milestone with the U.S. Food and Drug Administration (FDA)…
Illumina secures FDA approval for comprehensive cancer test and two companion diagnostics
Illumina, Inc. (NASDAQ: ILMN), a global leader in the field of DNA sequencing and array-based technologies, has secured…