FDA rejects J&J's subcutaneous Rybrevant filing and AZ's full approval bid for Andexxa
Fierce Pharma
DECEMBER 17, 2024
Johnson & Johnson has received coal in its stocking from the FDA as manufacturing issues have tripped up the companys attempt to gain approval of its subcutaneous version of lung cancer drug R | The FDA has sent complete response letters to Johnson & Johnson and AstraZeneca, rejecting J&J's application for subcutaneous Rybrevant and AZ's bid for a full approval of Andexxa.
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