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FDA Issues Complete Response Letter for Subcutaneous Amivantamab in NSCLC | Docwire News - 12 hour(s) ago

The Complete Response Letter “is related to observations as part of a standard pre-approval inspection at a manufacturing facility,” according to Johnson & Johnson officials.

Source: docwirenews.com

Categories: General Medicine News, Partners & KOLs

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  📄 The US FDA has issued a Complete Response Letter for the Biologics License Application for subcutaneous amivantamab in NSCLC, according to Johnson & Johnson officials. ➡️ Learn more about the letter and the next steps: https://t.co/xs6BiSv8x2 #lcsm #NSCLC #LungCancer https://t.co/JtUVhh3QXb