Flexibility in crisis: Disaster preparedness in clinical trials
The FDA guidance to provide clarity for sponsors running trials during war, disaster and PHE is released but questions remain.
07 November 2023
07 November 2023
The FDA guidance to provide clarity for sponsors running trials during war, disaster and PHE is released but questions remain.
The company submitted a supplemental new drug application to the FDA in June to complete the approval for Nefecon.
The domvanalimab regimen showed an encouraging overall response rate and progression-free survival.
Bayer’s Kerendia is the first nonsteroidal mineralocorticoid receptor antagonist for diabetes-related chronic kidney disease.
TILT Biotherapeutics’s candidate demonstrated a good safety profile and promising anti-tumour activity.
The data showed that 64% of the subjects who received Annamycin had stable disease through two cycles.
A 77% disease control rate was observed in trial subjects, as well as a partial response and stable disease rate of 38.5%.
The dose-ranging Phase IIa trial will evaluate the efficacy and safety of RTP-026.
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