FDA Related News

Trump Overruled Makary, RFK, to Fire Prasad: Sources

Politico reports that despite strong support from FDA commissioner Martin Makary and HHS secretary Robert F. Kennedy, Jr., President Trump insisted th...

Human Drugs

Senate Amendment Seeks to Block Illicit Drug Imports

U.S. Senators Ted Budd (R-NC) and Martin Heinrich (D-NM) introduce a bipartisan amendment to FDAs fiscal year 2026 spending bill to strengthen the age...

Human Drugs

FDA Orders New Mandatory Opioid Labeling

FDA orders new mandatory safety labeling changes for all opioid analgesics, a move aimed at curbing long-term misuse of the products.

Medical Devices

MDUFA Small Business Qualification Guide

FDA publishes a guidance explaining the process it uses to determine and qualify a MDUFA small business.

Human Drugs

Vivace Mesothelioma Drug Gets Orphan Status

FDA grants Vivace Therapeutics an orphan drug designation for VT3989 and its use in treating mesothelioma.

FDA General

House Dems Hit FDA, HHS Over Vaccines

Top House Democrats on the Energy and Commerce Committee raise alarm over what they describe as a coordinated effort by the Trump Administration to re...

Human Drugs

FDA Lays Out Unapproved GLP-1 Drug Concerns

FDA issues an online statement summarizing all its concerns with unapproved versions of GLP-1 weight loss drugs being marketed to U.S. consumers.

Human Drugs

AbbVie Seeks OK for All-Oral Leukemia Regimen

AbbVie files a supplemental NDA seeking approval for a new, fixed-duration, all-oral combination regimen of Venclexta (venetoclax) and acalabrutinib f...

Human Drugs

FDA Ends Arthritis Advisory Committee

FDA says its Arthritis Advisory Committee is no longer worth the effort and expense needed to maintain it, and it has been terminated.

Speed Access to Drugs and Cut Drug Use: Makary

FDA commissioner Martin Makary says he wants to find ways to get drugs to consumers faster, but also find ways to reduce the need for drugs by address...