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 ...
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 ...
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, ...
FiercePharma3d
UPDATED: Experts support FDA's plan for restrictions on PD-1 drugs in stomach, esophageal cancers
The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered.  | The days of broad stomach cancer labels ...
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 ...
Applied Therapeutics: FDA Stance Change For Advisory Panel Bodes Well For Review
Update on FDA's Applied Therapeutics, Inc. decision to remove advisory panel for govorestat review in treating galactosemia.
West Hawaii Today9h
Toxic chemicals found in food packaging; FDA under pressure to take action
Evidence is mounting that food packaging and plastic tableware contain toxic chemicals absorbed by humans, a public health ...
studyfinds3d
Alzheimer’s drug breakthrough or breakdown? Investigation exposes red flags in FDA approval of donanemab
A startling investigation has revealed a troubling story behind donanemab's approval -- one of questionable data, potential ...
JD Supra6d
New FDA clinical trials guidances promote efficient drug development, innovative designs, diversity
The U.S. Food and Drug Administration (FDA) issued this week three guidance documents related to clinical trials: a draft ...
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FDA scraps adcomm for Applied's rare disease drug ahead of November decision
After pushing back the decision date for Applied Therapeutics’ metabolic disorder drug govorestat, the FDA has now decided ...
FDA Casts Doubt On Use Of Merck, Bristol Myers' PD-1 Cancer Drugs For Certain Type Of Gastric Cancer Patients
The FDA's advisory committee is set to evaluate the use of PD-1 inhibitors in gastric cancer patients, focusing on the risks ...
The National Law Review5d
FDA Issues Revised Guidance on the Control of Nitrosamine Impurities in Human Drugs
The U.S. Food and Drug Administration (FDA) recently issued revised guidance on the control and mitigation of nitrosamine impurities in human drugs. The guidance provides a comprehensive roadmap for ...