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FDA’s Recent Guidance on Accelerated Approval and Implications for Rare Diseases
In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed ...
Examining The FDA's Recommendations For AI-Enabled Medical Devices
The FDA stated that its published medical device cybersecurity requirements from 2023 do include AI in a broad sense. However ...
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FDA, Other Experts Seek to Redefine Obesity and Prioritize Maintenance Treatment
Two recent documents—one from the FDA, the other from a commission organized by The Lancet Diabetes & Endocrinology—indicate ...
FDA recognizes need for immunogenicity assays in therapeutics with carriers or conjugates
A new article in the journal Nucleic Acid Therapeutics addresses the recognition by the U.S. Food and Drug Administration ...
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Vera Pomerantseva of eClinical Solutions Reacts to FDA’s Recent Protocol Deviations Guidance
In this video interview, Pomerantseva, director of product management, RBQM, eClinical Solutions, discusses the new guidance ...
Avadel Pharmaceuticals Reiterates 2025 Guidance as it Reports Fourth Quarter and Full Year 2024 Financial Results
LUMRYZ™ generated $50.4 million in sales in the fourth quarter, up 158% year-over-year, taking the full-year total to $169.1 million, in line ...
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American Society of Anesthesiologists shares guidance for safe nonanesthetic ketamine use
The American Society of Anesthesiologists released new guidance on the safe use of ketamine for nonanesthesia purposes, such ...
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Indiana joins states calling for the FDA to clamp down on counterfeit weight loss drugs
Over 30 state attorneys general including in Indiana, Kentucky, and Ohio have urged the Federal Food and Drug Administration ...
Hims stock tumbles 20% following Q4 report, 2025 guidance
Hims & Hers (HIMS) stock tumbled 20% post-market after the company released its Q4 earnings report and 2025 guidance amid a ...
Drug compounders sue US FDA over removal of Wegovy, Ozempic from shortage list
Drug compounders sued the U.S. Food and Drug Administration on Monday over its decision last week to remove Novo Nordisk's ...
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DCC asks expert committee to relook at guidelines for uniform implementation of powers of drug inspectors
Gireesh Babu, New Delhi Monday, March 3, 2025, 08:00 Hrs [IST] ...
Central drug regulator creating guidelines for gene therapies, biosimilars: DCGI
Cell and gene therapies, which involve the transfer of genetic material or cells into a patient for treatment, have been on ...