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 ...
WECT

Man arrested on drug charges after traffic stop for expired registration

This month marks 30 years since a sitcom episode aired that tackled what many parents describe as their biggest fear: a child facing cancer. The Wilmington Arena Project is inviting the public to its ...
WECT

Man arrested on drug charges after traffic stop for expired registration

WHITEVILLE, N.C. — A traffic stop for an expired registration led to a drug arrest in Whiteville on April 6. According to the Columbus County Sheriff’s Office, detectives saw a silver Dodge Ram with ...
MD&M East

FDA’s AI Device Regulations: Key Updates & Compliance Strategies for Medtech Success

FDA has moved artificial intelligence (AI) in medical devices from an exploratory concept to operational expectations, finalizing a pathway to pre-approved algorithm updates (PCCPs), publishing ...
Seeking Alpha

Mesoblast Receives IND Clearance from FDA to Directly Proceed to Registrational Trial for Approval of Ryoncil® in Duchenne Muscular Dystrophy

~15,000 children are living with DMD in the U.S. The trial will randomize 76 patients aged 5 to 9 years to either Ryoncil ® (7 infusions of 2 x 10 6 cells/kg over 9 months) or placebo, on top of ...
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 ...
Business Insider

NervGen Pharma Announces Successful End-of-Phase 2 Meeting and FDA Alignment on RESTORE, a Phase 3 Registrational Study of NVG-291 for Chronic Tetraplegia

Alignment with the FDA across proposed study parameters of RESTORE, a 16-week registrational study evaluating NVG-291 in chronic tetraplegia. Primary endpoint will be the change from baseline in ...
BioSpace

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

NORWOOD, Mass., April 07, 2026 (GLOBE NEWSWIRE)-- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP), a clinical-stage company focused on promising new therapies in oncology and obesity, today ...