Bayer Gets Speedy FDA Review of Kerendia in Heart Failure
Bayer has won U.S. Food and Drug Administration priority review for its application seeking expanded approval of its kidney-disease drug Kerendia in certain people with heart failure.
Trump's FDA pick says he'll review whether abortion pill must be dispensed in person again
Dr. Marty Makary, Trump's nominee to lead the FDA, said he would review a Biden-era rule that allowed patients to obtain ...
Managed Healthcare Executive10h
FDA Grants Priority Review to Kerendia in Heart Failure
Regulators are expected to make a decision in the third quarter of 2025 on Kerendia to treat patients with heart failure with ...
Trump’s pick to lead FDA tells senators he’d look into food, abortion pill, vaccine advisers
President Donald Trump’s pick to lead the US Food and Drug Administration told senators in a tense confirmation hearing ...
BioSpace10d
This Might Be a Moot Point but the FDA’s Priority Review Vouchers Need Transparency
While Congress is renewing the priority review voucher program for rare pediatric diseases, the FDA should be required to ...
MPR10h
Finerenone Under Review for Patients With Heart Failure and LVEF ≥40%
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for finerenone for the treatment of ...
Trump's FDA Staff Cuts Weigh on Agency's Drug Oversight Work
The Trump administration’s moves to shrink the federal workforce put the FDA’s ability to regulate drugs and oversee the ...
PharmaTher receives FDA priority review for ketamine new drug application
Ketamine stock PharmaTher Holdings (CSE:PHRM) has received an amendment acknowledgement letter from the U.S. Food and Drug ...
Beyond Pesticides22h
Can FDA Step In When EPA Fails to Ensure Safety from Pesticide Mixtures in Food?
When Secretary of Health and Human Services Robert F. Kennedy, Jr. announced last week that he is directing the U.S. Food and ...
Makary tells Senate panel he plans to review FDA job cuts
FDA nominee Martin Makary was asked about abortion drugs, vaccine panels during a Senate hearing on his bid to lead the ...
Compound versions of some weight loss drugs to be restricted
Zepbound contains the same active ingredient, tirzepatide, as Mounjaro, which is also made by Lilly and is FDA-approved to treat Type 2 diabetes. Some doctors also prescribe Mounjaro "off-label" for ...
JD Supra3d
FDA’s Backup LDT Enforcement Method: Specimen Collection Kits
We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...