MedPage Today7h
Clozapine's REMS Program on the Chopping Block at Upcoming FDA Meeting
"Severe neutropenia occurs in a small percentage of patients taking clozapine; however, neutropenia is associated with an ...
FiercePharma3d
FDA rejects Intercept's ask for Ocaliva full nod in rare liver disease, but accelerated approval remains
In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval ...
Hosted on MSN1d
FDA Proposes Pulling Ineffective Decongestant From Market
An FDA advisory committee has unanimously concluded that oral phenylephrine, a decongestant found in many cold and flu ...
The FDA wants these cold medicines off the shelves. Should Canada follow?
The FDA has proposed removing phenylephrine, a common ingredient in decongestants, due to its ineffectiveness, which may ...
JD Supra1d
FDA Advisory Committee outlines informed consent best practices
The U.S. Food and Drug Administration (FDA) recently held a Patient Engagement Advisory Committee meeting focused on clinical trial informed ...
These Cold and Flu Medicines Contain Phenylephrine, the Ingredient the FDA Plans to Ban
Phenylephrine is a medication that’s been used to relieve nasal congestion caused by colds, allergies, and hay fever, per the ...
RFK Jr. pick sparks FDA concerns
Robert F. Kennedy Jr.’s selection Thursday as President-elect Donald Trump’s Health and Human Services secretary nominee sent shockwaves through Washington.
A Popular Decongestant Doesn’t Work. The FDA Is Finally Doing Something About It
Oral phenylephrine was shown to be ineffective for treating nasal congestion over a year go. This week, the FDA took the ...
CCHR Int6h
CCHR Urges FDA Overhaul to End Psychiatric Drug and Device Harms
The Mental Health Watchdog calls for reforms to protect public safety, citing decades of antidepressant, electroshock, and psychedelic drug risks.
About 100 decongestant lawsuits claiming bogus ingredient tossed
A New York federal judge on Tuesday dismissed about 100 lawsuits that claimed Procter & Gamble , Haleon and other companies ...
MedPage Today4d
FDA Rejects Full Approval of Liver Disease Drug
said during the advisory committee meeting in September. "Design a real study, do a real study, then we can talk about the ...