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186,299 Results for "fda".
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Artificial intelligence
FDA’s New AI Guidance Highlights Risks of Technology, Urges Early Sponsor Engagement
The FDA’s guidance on AI in drug development points to potentially life-threatening consequences of the technology, highlighting the importance of providing the regulator with detailed information regarding models’ development and maintenance.
January 7, 2025
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2 min read
·
Tristan Manalac
Regulatory
5 FDA Decisions to Watch in Q1
Among the FDA’s pending decisions for this quarter are Vertex’s non-opioid pain drug and Sanofi’s RNA interference therapy for hemophilia A and B.
January 6, 2025
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8 min read
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Tristan Manalac
Regulatory
Keytruda and Opdivo Scrutiny Highlights FDA’s Evolving Biomarker Focus
An FDA committee’s September 2024 vote to limit the use of Merck’s Keytruda and BMS’ Opdivo in stomach and esophageal cancers based on PD-L1 expression levels reflects an emerging trend that leverages ever-maturing datasets.
January 13, 2025
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5 min read
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Kate Goodwin
Regulatory
Deep Dive: FDA’s Accelerated Approval Pathway Under Fire
In this deep dive
BioSpace
explores the opportunities and challenges presented by the FDA’s accelerated approval program.
November 18, 2024
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2 min read
·
Heather McKenzie
People
Lykos Loses Five Board Directors After FDA Rejection
Lykos Therapeutics is currently working out ways to fund an additional Phase III study for its MDMA-assisted PTSD therapy following an FDA setback last year.
January 15, 2025
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2 min read
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Tristan Manalac
Regulatory
After Drug Rejection, Vanda Blasts ‘Unacceptable’ FDA Conduct in Letter to Commissioner
Vanda called the attention of FDA Commissioner Robert Califf to what it termed the “sentiment that the agency avoids public scrutiny of its decisions.”
January 9, 2025
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2 min read
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Tristan Manalac
Postmarket research
Intercept’s Troubled Drug Ocaliva Linked to ‘Serious Liver Injury’: FDA
Ocaliva recently failed to secure the FDA’s traditional approval for primary biliary cholangitis due to safety concerns.
December 13, 2024
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2 min read
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Tristan Manalac
Weight loss
FDA Proposes Setting Bar for Weight-Loss Therapies as Obesity Space Heats Up
In a rare move, the FDA recommended a minimum of 5% weight-loss for drug developers seeking to establish the efficacy of their investigational obesity candidates.
January 8, 2025
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3 min read
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Tristan Manalac
Regulatory
FDA Action Alert: Ionis, Lexicon, Bristol Myers Squibb and More
The FDA’s year-end rush includes nine target action dates, mostly for rare disease and cancer therapies.
December 9, 2024
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7 min read
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Tristan Manalac
Drug shortages
Legal Challenge Over Lilly’s GLP-1 Shortages Highlights FDA’s Post-Chevron Vulnerability
Currently, Eli Lilly’s GLP-1 drugs Mounjaro and Zepbound (tirzepatide) are not on the FDA’s shortage list but compounded pharmacies are still making them. That’s unprecedented.
November 26, 2024
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4 min read
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Ben Hargreaves
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