DBV and FDA aligned on key study design elements for the COMFORT Toddlers study in 1 – 3 year-olds, including study size and wear time collection methodology and analysis COMFORT Toddlers study ...
Accelerated approvals for cancer drugs is a good idea in theory. This US Food and Drug Administration (FDA) pathway allows promising new cancer agents to reach the market, and patients, sooner. But ...
On Dec. 6, 2024, the FDA released draft guidance, marking a significant development in the regulatory framework for therapies approved under the Accelerated Approval Program. The 22-page guidance ...
The Food and Drug Administration’s accelerated approval program aims to speed “approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint” of overall ...
“It would not be surprising to not see new FDA guidance documents issued for some period of time,” said David Larwood, CEO of Valley Fever Solutions, about the potential impact of the US Food and Drug ...
SAN DIEGO, June 9, 2025 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide ...
When Vinay Prasad was tapped to lead the Food and Drug Administration’s Center for Biologics Evaluation and Research, the health care world braced for its effect. Known for his critical analyses of ...
- In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease ...
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