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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.

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FDA approves Biostar’s Phase II/III plans with utidelone injectable for NSCLC

Pharmaceutical Technology

Synthetic biology biopharma Biostar Pharma announced is ready to advance its utidelone injectable (UTD1) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), following approval from the US Food and Drug Administration (FDA) for the study. as the secondary endpoints. ORR, 81.0% DCR (disease control rate), 4.37

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