News

Lawmakers press FDA to target knockoff weight-loss drug
Dozens of lawmakers are urging US health regulators to crack down on the booming market for knockoff weight-loss drugs amid ...
Houston-based Empower Pharmacy’s drugs raised red flags for FDA and other states, but not Texas
Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.
JD Supra7h
Before it hits the shelf: FDA reprocesses the new dietary ingredient notification process
On June 11, 2025, the US Food and Drug Administration (FDA) released educational materials to broaden dietary supplement manufacturers’ ...
PharmExec9h
Replimune CRL Fallout: How Biopharma Leaders Should Manage a New Layer of FDA Uncertainty
A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...
Applied Clinical Trials Online8h
FDA Crackdown on Trial Design: What July’s CRLs to Replimune and Capricor Mean for Sponsors
Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.
PharmTech12h
CMC and Analytical Gaps in CRLs: Why They Persist Despite FDA Guidance and How You Can Position Yourself for Success
Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...
Physician's Weekly17h
FDA Upgrades Recall on 160,000+ Bottles of Thyroid Medication
The U.S. Food and Drug Administration (FDA) has upgraded a recall of a commonly prescribed thyroid medication due to what it ...
Inventor claims bleach injections will destroy cancer tumors
Xuewu Liu, a Chinese inventor who has no medical training or credentials of any kind, is charging cancer patients $20,000 for ...
Healio11h
Treatment for thyroid eye disease in an exciting era of growth
There was a lot of excitement when Tepezza became the first drug approved for the treatment of thyroid eye disease in January ...