US FDA lifts clinical hold on Biomea's diabetes trials after safety review
The U.S. Food and Drug Administration lifted a clinical hold on Biomea Fusion's ongoing studies of its experimental drug for ...
The Washington Post on MSN2d
FDA approves a novel drug for schizophrenia, a potential ‘game changer’
They called their experimental drug KarXT, and shepherded it through clinical trials to prove its safety and effectiveness.
F.D.A. Approves the First New Schizophrenia Drug in Decades
Available antipsychotic treatments work by blocking dopamine receptors. The new drug, Cobenfy, takes a different approach.
STAT3d
FDA introduces plan to assess safety of common chemicals added to food
After years of pressure, the FDA said it is strengthening its review of many chemical additives used to enhance color, ...
FDA alerts patients about Pfizer's Oxbryta withdrawal
The U.S. Food and Drug Administration on Thursday alerted patients and healthcare professionals about the withdrawal of ...
Critical Flaws: New Alzheimer’s Drug Could Actually Be a Safety Risk
An investigation has uncovered alarming issues including increased mortality rates, absent safety records, dubious efficacy, ...
FDA approves new kind of drug for schizophrenia
The first new type of medication in decades to help fight against schizophrenia was approved on Thursday by the U.S. Food and ...
Meat2d
GRAS article triggers FDA response
Broad Leib, a clinical professor of law at Harvard Law School, said the FDA should require that manufacturers share all new ...
This FDA-approved drug promises a new way to treat schizophrenia
Bristol Myers Squibb's drug, KarXT, improved symptoms of adults with schizophrenia and had fewer side effects than ...
JD Supra3d
FDA to Study Presence of Metals in Tampons: What to Know
Biocompatibility and Toxicology Program published a statement announcing its intention to commission an independent literature review and internal bench laboratory study to evaluate the presence of ...
Becker's Hospital Review3d
FDA eyes 1st schizophrenia drug in decades: 5 things to know
The FDA is set to make a pivotal decision Sept. 26 about KarXT, a novel antipsychotic developed by Karuna Therapeutics. If approved, it would be the first drug with a unique mechanism for treating ...