In a new draft guidance issued on January 14, 2026, the FDA discussed the use of a modern statistical methodology in clinical trials designed to ...
On January 6, 2026, the FDA issued a Guidance for Industry and Food and Drug Administration Staff regarding Clinical Decision Support (CDS) ...
Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will ...
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Novo awaits FDA call on higher-dose Wegovy in early 2026 – NVO stock extends decline pre-market on weak guidance
In an interview with CNBC on Wednesday, CEO Doustdar said people should expect the company’s share price to go down before it ...
The program will allow for frequent communication with the FDA, giving manufacturers timely input and guidance regarding the ...
The FDA draft guidance recommends MRD and CR as endpoints for accelerated drug approval in multiple myeloma, emphasizing ...
New draft guidance from the FDA on multiple myeloma endpoints reflects the new technology available to assess disease and how patient journeys have changed with better treatments.
The FDA has approved a label update for an inhaled insulin indicated for adults with type 1 or type 2 diabetes, according to ...
American women are silently suffering while the FDA drags its feet on reviewing the abortion drug mifepristone.
For companies developing interchangeable biosimilars, the FDA guidance opens the door to more tailored, risk-based programs that may reduce reliance on costly comparative efficacy studies (CES). For ...
The US Department of Health and Human Services (HHS) issued new guidance clarifying how pharmaceutical manufacturers can ...
In a pilot, Utah is testing use of AI for renewing drug prescriptions. Experts ask if it should be regulated as a medical ...
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