Submission packages—such as drug master files for active ingredients—are pre-validated by an AI engine, allowing companies to ...
In third part of his Pharma Commerce video interview, Faisal Khan, a GRC solutions expert with Vanta, emphasizes the need for ...
This comes during a time when when Eli Lilly and Novo Nordisk have been garnering momentum—last week, the FDA added ...
This episode of Pharma Pulse explores a major review finding no link between maternal acetaminophen use and autism or ADHD, ...
This episode of Pharma Pulse explores how regulators modernize safety information for hormone therapy, new data that ...
Novartis has unveiled a 10,000-square-foot radioligand therapy (RLT) production plant in Carlsbad, CA, representing a move ...
Launching next year, the new CMS Innovation Center initiative—known as the GENEROUS Model—aims to align Medicaid drug prices ...
This episode of Pharma Pulse discusses FDA’s growing National Priority Voucher initiative, fresh data on oral semaglutide’s ...
This episode of Pharma Pulse discusses how the FDA’s new plausible mechanism pathway, WeightWatchers’ plans to offer oral Wegovy, and emerging evidence on berberine are shaping the future of obesity ...
Ultimately, Khan emphasized that protecting PHI requires more than compliance checkboxes—it demands a continuous, structured ...
Pharma Pulse: FDA Appoints Richard Pazdur as CDER Director Amid 340B Tensions and Novartis Expansion
This episode of Pharma Pulse discusses how Dr. Richard Pazdur’s appointment signals a new era for FDA drug evaluation, why hospitals are opposing the government’s 340B pilot program, and how Novartis ...
Starjemza's inclusion in Cost Plus Drugs' portfolio aims to challenge traditional specialty medication economics and enhance ...
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