Medical Device and Diagnostic Industry (MD+DI)

Navigating the QMSR Transition: Expert Insights on FDA Compliance, Risk Management, and Global Harmonization

Expert insights on QMSR compliance: transition steps, gap assessments, risk-based approach, and global harmonization with ISO ...
National Law Review

How MoCRA Is Reshaping FDA Oversight of Cosmetics in 2026

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant change to U.S. cosmetic regulation since the Federal Food, Drug, and Cosmetic Act (FD&C Act) was enacted in 1938.
Health.com

FDA Announces Nationwide Recall of Cholesterol Medication—More Than 140,000 Bottles Affected

Amber is the Associate Editorial Director overseeing news content for Health, ensuring that readers stay up-to-date on trending topics like COVID-19, as well as the most recent research in the health ...
dvm360

FDA is hosting public meetings to discuss drug user fee legislation

Officials with the FDA have announced virtual public meetings to discuss the Animal Drug User Fee Act (ADUFA) and Animal ...
Business Insider

Corbus Pharmaceuticals Announces Broad Alignment with FDA on Registration Path for CRB-701 in Second-Line HNSCC and Cervical Cancer

FDA feedback enables Corbus to proceed with proposed registrational study design and endpoints to support potential accelerated approval in second-line HNSCC and cervical cancer Updated CRB-701 ...
USA Today

FDA: Novo Nordisk failed to report deaths of weight-loss drug patients

The manufacturer of popular weight-loss drugs Ozempic and Wegovy, Novo Nordisk, is taking heat from the federal government for regularly failing to report potential side effects of its GLP-1 ...
Scientific American

FDA declines to approve drug touted by Trump as a treatment for autism

The FDA on Tuesday approved leucovorin as a treatment for a rare genetic condition, not for autism, as the Trump administration had suggested The U.S. Food and Drug Administration on Tuesday approved ...
PBS

FDA finds little evidence that the generic drug leucovorin can help people with autism

WASHINGTON (AP) — The Food and Drug Administration on Tuesday approved a generic medication for a rare brain disorder, while walking back suggestions by President Donald Trump and other administration ...
Bloomberg L.P.

US Senator Investigates FDA Over Rare-Disease Drug Denials

A key US Republican senator said he’s launched an investigation into the Food and Drug Administration’s recent denials of treatments for rare diseases, adding political pressure on an agency that’s ...
CNBC

FDA official calls UniQure's gene therapy a 'failed' treatment for Huntington's disease

UniQure needs to run another study to prove its gene therapy "actually helps people with Huntington's disease," a senior FDA official said. The official said UniQure is the "latest company to make a ...
The Hill

FDA sends warning to 30 telehealth companies selling ‘illegal’ GLP-1s

The Food and Drug Administration (FDA) on Tuesday sent 30 telehealth companies warning letters about their “illegal” sales of compounded GLP-1s, building off increasing pressure to tamp down on the ...
The Business Journals

Medical startup founded by OrthoCarolina surgeons finds promise in VR treatment for phantom limb pain

To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min The device combines virtual ...