Pharmabiz9h
US FDA grants fast track designation to NKGen Biotech’s natural killer cell therapy, troculeucel to treat moderate Alzheimer’s disease
US FDA grants fast track designation to NKGen Biotech’s natural killer cell therapy, troculeucel to treat moderate Alzheimer’s disease: Santa Ana, California Saturday, Februar ...
Battle of the journals
Two Trump administration nominees with long track records of challenging the medical and public health establishments have ...
OS Therapies gears up for FDA meeting on cancer drug
NEW YORK - OS Therapies, Inc. (NYSE-A: OSTX), a small-cap biotech firm with a market capitalization of $42 million focusing on cancer treatment solutions, has announced the completion of its Phase 2b ...
STAT2d
The FDA must remove an unnecessary barrier to the use of clozapine for treatment-resistant schizophrenia
If the FDA follows an advisory committee’s vote, it can potentially be a transformative step in the delivery of mental health ...
manilatimes3d
NKGen Biotech Receives U.S. FDA Fast Track Designation for Troculeucel for the Treatment of Moderate Alzheimer's Disease
NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic NK cell therapeutics. NKGen is headquartered in Santa Ana, ...
manilatimes3d
Replimune Reports Fiscal Third Quarter 2025 Financial Results and Provides Corporate Update
U.S. Food and Drug Administration (FDA) recently accepted the Biologics License Application (BLA) for RP1 plus nivolumab in advanced melanoma for priority review with a PDUFA date of July 22, 2025 ...
SpringWorks Therapeutics Announces FDA Approval of GOMEKLIâ„¢ (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN
GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN –– Approval based on positive data ...
Monthly Prescribing Reference3d
Troriluzole Priority Review Granted for Spinocerebellar Ataxia
The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for troriluzole for the treatment of adults with ...
DOGE can cut spending, but can it make government more accountable?
While DOGE aims to centralize authority, a new budget process that includes expanding the House would distribute ...
Biohaven Ltd.: Biohaven Announces FDA Acceptance and Priority Review of Troriluzole New Drug Application for the Treatment of Spinocerebellar Ataxia
Spinocerebellar Ataxia (SCA) is a rare, genetic, life-threatening neurodegenerative disease with no available treatment. Troriluzole demonstrated a 50-70% slowing of SCA disease progression ...
Biohaven's troriluzole gains FDA priority review for SCA
NEW HAVEN, Conn. - Biohaven Ltd. (NYSE: BHVN), a biotechnology company with a market capitalization of $3.87 billion, announced today that the U.S. Food and Drug Administration (FDA) has accepted its ...