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
FDA approves RYBREVANT and LAZCLUZE for EGFR-mutated advanced lung cancer
The U.S. Food and Drug Administration (FDA) has approved the combination of RYBREVANT (amivantamab-vmjw) and LAZCLUZE (lazertinib) as a first-line therapy for adults with advanced ... Read More
Niktimvo FDA approval brings new hope for chronic graft-versus-host disease patients
The U.S. Food and Drug Administration (FDA) has approved Niktimvo (axatilimab-csfr), an anti-CSF-1R antibody, for treating chronic graft-versus-host disease (GVHD) in patients who have not ... Read More
FDA gives green light to Guardant Health’s Shield blood test: A game-changer in colorectal cancer screening and Medicare coverage
In a landmark decision, the U.S. Food and Drug Administration (FDA) has approved Guardant Health, Inc.'s Shield blood test as a primary screening option for ... Read More
Sun Pharmaceutical bags LEQSELVI FDA approval for severe alopecia areata
In a significant development for the treatment of severe alopecia areata, Sun Pharmaceutical Industries Limited has announced that the U.S. Food and Drug Administration (FDA) ... Read More