Sponsor seeks accelerated approval for low-risk, early-stage prostate cancer based on a trial that met its coprimary endpoints, but agency says interpretation of those results is complicated by novelty of the outcomes, data quality issues and increase in genitourinary adverse events.
Steba Biotech S.A.’s prostate cancer therapy Tookad (padeliporfin di-potassium powder) is heading into a US Food and Drug Administration advisory committee review on 26 February amid agency questions about novel clinical trial endpoints, missing data and toxicity.
In a briefing document released 24 February, the agency asks the Oncologic Drugs Advisory Committee to consider whether the...
In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.
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Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.
