FDA approval of Filkri expands Accord’s G-CSF biosimilar portfolio, offering a short-acting option for neutropenia in cancer care.
InvestorsHub on MSN
Spruce Biosciences reports positive FDA meetings as it prepares TA-ERT filing for rare pediatric disorder
Spruce Biosciences, Inc. (NASDAQ:SPRB) said it has completed two Type B meetings with the U.S. Food and Drug Administration (FDA), clearing key regulatory discussions ahead of its planned biologics ...
The U.S. Food and Drug Administration (FDA) has approved Filkri (filgrastim-laha), a biosimilar to Neupogen (filgrastim), to ...
The world’s first AI-based optical diagnostic platform offers potential for near-instant diagnosis of CSF rhinorrhea.
Researchers have uncovered a distinctive network of lymphatic vessels at the back of the nose that plays a critical role in draining cerebrospinal fluid (CSF) from the brain. The study, sheds light on ...
Fujirebio has been developing tests for Alzheimer’s disease for decades, but it wasn’t until May 2025 that it received approval from the U.S. Food ...
Indeed, Defendant Matthew Kapusta, the Company's Chief Executive Officer, assured investors of the Company's alignment with the FDA during calls with investors on June 2, 2025, and July 29, 2025.
The FDA raised concerns about multiple facets of the study protocol used to evaluate RGX-121, including the eligibility criteria and surrogate endpoints.
Cerebrospinal fluid (CSF)-based molecular tests can reliably distinguish multiple sclerosis (MS) from other neurological ...
One of the largest autism trials of leucovorin (Wellcovorin), a drug used to treat cerebral folate deficiency, was retracted ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results