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Sublocade Priority Review for Expanded Labeling

[ Price : $8.95]

FDA awards a priority review for an Indivior prior approval supplement for Sublocade (buprenorphine) extended-release injection fo...

AdvaMed Seeks FDA Best Practice on Trial Diversity

[ Price : $8.95]

AdvaMed says that as FDA begins receiving and reviewing diversity action plans, it should publicly disclose any key best practices...

Comments Sought on Pharmaceutical Quality Terminology

[ Price : $8.95]

FDA requests comments on a draft document about controlled terminology/vocabulary that applies to a set of coded quality attribute...

Medtronic Recalls MiniMed Pumps Over Batteries

[ Price : $8.95]

Medtronic recalls (Class 1) its MiniMed Insulin pumps due to concerns about reduced battery life in certain situations.

FDA Clears PlaqueIQ for Cardiovascular Disease

[ Price : $8.95]

An Elucid 510(k) gains clearance for its PlaqueIQ imaging analysis software to help physicians diagnose cardiovascular disease.

Thermo Fisher Plant Scrutinized by FDA: Reuters

[ Price : $8.95]

A Reuters article looks into drug GMP issues raised by FDA inspections over the past decade at Thermo Fisher's Greenville, NC drug...

CDRH Portal Update Tracks PMA Submissions

[ Price : $8.95]

FDA updates CDRHs Customer Collaboration Portal to track the progress of PMA applications and accept Small Business Determination...

Drug-Drug Interaction Assessments Lacking: FDA Research

[ Price : $8.95]

FDA says that 22% of new molecular entities required postmarketing requirements or postmarketing commitments to address knowledge ...

J&J Discontinues Dengue Virus Antiviral Development

[ Price : $8.95]

Johnson & Johnson discontinues a Phase 2 study evaluating mosnodenvir for preventing dengue virus in adults aged 18-65 years.

Tirzepatide Shortage Resolved, FDA Says

[ Price : $8.95]

FDA says the shortage of Lillys Mounjaro and Zepbound has been resolved but other similar products remain in short supply.