Pharmabiz8h
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 ...
FDA’s plan to propose ban on formaldehyde in hair-straightening products remains in limbo under Trump administration
A plan for the US Food and Drug Administration to propose banning formaldehyde and certain formaldehyde-releasing chemicals ...
Acsh.org4d
Rare Diseases Are Neglected. The FDA Needs A Dedicated 'Center of Excellence for Rare Diseases'.
The FDA has made some modest efforts, but it needs an internal organization that understands and would be an aggressive ...
medtechdive3d
Former FDA head Gottlieb calls for less regulation of certain AI tools
Gottlieb, who led the agency during the first Trump presidency, supports a reversion to an earlier interpretation of the 21st ...
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 ...
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 ...
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 ...
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, ...
FiercePharma3d
Amid takeover talk, SpringWorks scores FDA nod for rare genetic disease treatment Gomekli
Tuesday, the agency signed off on SpringWorks’ Gomekli (mirdametinib) as a treatment for the rare genetic disorder ...
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 ...