Tag: FDA
Business & Industry
FDA Opens Door to Innovative Approaches for Psychedelic Drug Development Amid Mental Health Crisis
Senior officials at the US Food and Drug Administration have signaled that the agency is open to novel and innovative approaches in the clinical...
Business & Industry
FDA Proposes New Rule for Drug Manufacturing Registration
The modernization of regulatory frameworks is becoming essential to support the pharmaceutical industry’s transition toward advanced production models and to ensure the resilience of...
Business & Industry
FDA and MHRA Launch New Liaison Programme to Strengthen Regulatory Collaboration
The US Food and Drug Administration (FDA) and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) have announced a significant new liaison programme...
Business & Industry
Sanofi Advances T1D Treatment with Tzield FDA Approval in US
The US Food and Drug Administration (FDA) has granted accelerated approval to Sanofi’s Tzield (teplizumab-mzwv) for children aged eight to 17 years who have...
Business & Industry
Pfizer’s Hympavzi Wins FDA Expanded Approval for Haemophilia A and B
Pfizer has secured an expanded indication approval from the US Food and Drug Administration (FDA) for Hympavzi (marstacimab-hncq), broadening its use in the treatment...
Business & Industry
FDA Grants Approval for Chronic Hepatitis Delta Virus Treatment from Gilead Sciences
The U.S. Food and Drug Administration (FDA) has granted approval for Gilead Sciences's Hepcludex, an experimental drug designed to treat chronic hepatitis delta virus...
Business & Industry
FDA Advances Real-Time Clinical Trials With AstraZeneca, Amgen
The U.S. Food and Drug Administration has unveiled a new regulatory initiative to enable real-time clinical trials, marking a structural shift in how drug...
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