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Human Drugs

Senators Introduce Bill for Homeopathic Product Pathway

Senators Mike Lee (R-UT) and Tommy Tuberville (R-AL) introduce the Homeopathic Drug Product Safety, Quality, and Transparency Act.

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Human Drugs

Lilly's Oral GLP-1 Outperforms Oral Semaglutide in Diabetes Trial

Eli Lilly reports Phase 3 study results showing its oral GLP-1 receptor agonist Foundayo (orforglipron) outperformed Novo Nordisk's oral semaglutide o...

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FDA General

AMA Delegates Call for Tighter FDA Oversight of Unapproved Peptides

Delegates at the American Medical Association's annual meeting vote to support stronger FDA oversight of synthetic peptide products, citing growing co...

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Human Drugs

Clinical Hold on Quantum IND

FDA places a clinical hold on Quantum BioPharmas IND for its multiple sclerosis drug candidate Lucid-21-302.

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Human Drugs

Induced Infringement Decision Analyzed

Eight Mintz attorneys analyze the recent Supreme Court decision giving generic drug manufacturers a victory in an induced infringement case.

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FDA General

FDA AI Inspections Prompts Industry Readiness Strategy Rethink

Former FDA enforcement official suggests new strategies for industry to prepare for agency inspections that rely on artificial intelligence tools.

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Human Drugs

Agency Defends Generic Drug Oversight

FDA officials are seeking to bolster confidence in generic medicines, highlighting the agency's oversight of drug manufacturing, inspection programs a...

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Human Drugs

FDA Seeks Industry Data for Kidney Biomarker Initiative

FDA launches a new effort to aggregate clinical trial data on kidney safety biomarkers, seeking pharmaceutical industry participation in a pilot progr...

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Medical Devices

Alert on GE HealthCare Infant Resuscitation Systems

FDA issues an early alert warning healthcare providers about a potentially high-risk defect affecting certain infant resuscitation systems manufacture...

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FDA General

PhRMA Urges FDA to Clarify Digital Health Technology Standards

PhRMA calls on FDA to provide clearer regulatory expectations for the use of digital health technologies in drug development, arguing that adoption ha...