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- FDA releases updated guidances for injectable peptide drugs and announces FY 2027 user fee ratesThe FDA has updated 17 draft product-specific guidances aimed at helping sponsors prepare abbreviated new drug applications for injectable peptide products. The guidances cover peptide therapies u…
- Study Finds Accelerated Approval Rarely Used for Adult Cancer Drugs Over Past 20 YearsA new analysis published in JAMA shows that most adult oncology medicines approved by the FDA in the last two decades received standard approvals for expanded uses, relying on surrogate endpoints r…