News

Targeted Oncology23h
Drug Approval Hurdles: Funding & Regulation Slow Life-Saving Cures
Unpredictable FDA and funding woes delay crucial drug approvals, depriving thousands of patients access to vital treatments ...
JD Supra1d
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’ ...
Lawmakers Press FDA to Target Compounded, Fake Weight-Loss Drugs
Dozens of lawmakers are urging US health regulators to crack down on the booming market for knockoff weight-loss drugs amid ...
BioSpace1d
Sarepta’s Future Increasingly Uncertain as FDA Eyes New Study for Elevidys
CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...
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 ...
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.
Que.com on MSN1d
AI in FDA Drug Approvals Sparks Controversy Over Fabricated Studies
In recent years, Artificial Intelligence (AI) has made significant strides across various sectors, providing innovative solutions and enhancing efficiency. However, ...
The FDA Is Using an AI to "Speed Up" Drug Approvals and Insiders Say It's Making Horrible Mistakes
Insiders at the Food and Drug Administration are ringing alarm bells over the agency's use of an AI to fast-track drug ...
JD Supra1d
Beyond Guinea Pigs: Patent Risks and Opportunities in AI-Enabled Drug Development
On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in ...
The American Journal of Managed Care1d
RP1 Plus Nivolumab Receives CRL for Advanced Melanoma
The CRL was given because the FDA did not consider the phase 1/2 IGNYTE trial to be an adequate and well-controlled clinical ...
100 days into the job, FDA head talks to CNN about agency goals— and Coke’s switch to sugar
Commissioner Marty Makary says the FDA will plow ahead with big plans on ultra process foods, dietary guidelines and ...
Managed Healthcare Executive2d
FDA Extends Review of Blenrep Combinations in Multiple Myeloma
Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing ...