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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 ...
MedPage Today11h
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 ...
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 ...
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 ...
ScienceAlert on MSN5d
FDA to Finally Ban Controversial Ingredient in Popular Decongestants
Sudafed, Mucinex, Benadryl, Advil, Tylenol, Vicks, and Dimetapp. These popular brand names appear on oral decongestants that ...
STAT11d
A Q&A with the FDA’s top vaccine regulator amid a fresh wave of disinformation
A fresh wave of disinformation about vaccines is flaring amid the 2024 campaign. The FDA's top vaccine official believes ...
FDA to pull common but ineffective cold medicine from market
The FDA says oral phenylephrine, used in many over-the-counter cough and cold medicines, "is not effective as a nasal ...
FDA Wants To Pull Popular OTC Decongestant Used For Common Cold Over Effectiveness Concerns
On Thursday, the FDA proposed removing oral phenylephrine from the list of approved active ingredients for over-the-counter ...
FDA proposes removing ineffective decongestant found in most cold medicine
FDA officials said an agency review of the available data found oral phenylephrine is not effective as a nasal decongestant ...
JD Supra2d
Inaugural Meeting for FDA's Digital Health Advisory Committee to Focus on GenAI-enabled Medical Devices
The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and ...
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.