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 Administration (FDA) approved Unloxcyt (cosibelimab-ipdl) treatment for ... Read More
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 the treatment of classic congenital adrenal hyperplasia ... Read More
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 features to orthodontic care. This update is ... Read More
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 comfort of glioblastoma multiforme (GBM) patients using ... Read More
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 self-administration or caregiver-administration. This marks a significant ... Read More
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 for Niemann-Pick disease type C (NPC), a ... Read More
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 inhibitor for subcutaneous injection, developed by Genentech, ... Read More
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) approving the supplemental Biologics License Application (sBLA) ... Read More
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 crucial approval from the Food and Drug ... Read More
Renalytix plc terminates formal sale process amid strategic realignment and market reaction
Renalytix plc, a prominent player in artificial intelligence-enabled in vitro diagnostics, has officially terminated its Formal Sale Process, citing a lack of viable acquisition offers ... Read More