Early access to new cancer drugs, granted accelerated approval by the U.S. Food and Drug Administration (FDA), has provided mixed benefits for patients while costing Medicare billions of dollars, ...
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 ...
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 ...
“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 ...
A report showed that in cancer drug indications that received FDA accelerated approval, demonstrated high clinical benefits correlated with shorter times to subsequent full approval. Nearly a quarter ...
Nath stated, "We plan to meet with the FDA to discuss these results and explore next steps in getting COMP360 to patients as rapidly as possible." Loxam reiterated, "We are finalizing a PTSD study and ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback