AstraZeneca, Merck hit with 3-month delay for Lynparza's FDA filing in first-line...

cafead

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  • cafead   Dec 15, 2022 at 11:22: AM
via It’s been relatively smooth sailing for AstraZeneca and Merck’s Lynparza as it has gained indications in ovarian, breast, pancreatic and prostate cancer.

But on Thursday, the companies reported a snag as the FDA has delayed its target date for its decision on Lynparza in metastatic castration-resistant prostate cancer (mCRPC). The agency has pushed back the decision date to February to “provide further time for the full review of the submission,” Merck said.

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