| Tipoffs for Concord, New Hampshire (Federal Agencies) Newsletter for Tuesday March 26, 2024 ( 2 items ) |
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FDA Withdraws Approval of 3 New Drug Applications by Clovis Oncology, AstraZeneca Pharmaceuticals, GlaxoSmithKline
WASHINGTON, March 26 -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a notice, published in the Federal Register on March 26, 2024, entitled "Clovis Oncology, Inc., AstraZeneca Pharmaceuticals LP, and GlaxoSmithKline LLC; Withdrawal of Approval of the Indications for Advanced Ovarian Cancer for Poly (ADP-Ribose) Polymerase Inhibitors RUBRACA (Rucaparib) Tablets, LYNPARZA (Olaparib) Tablets, and ZEJULA (Niraparib) Capsules."
The notice was issued by La
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FDA Withdraws Approval of New Drug Application for Lynparza Capsules by AstraZeneca Pharmaceuticals
WASHINGTON, March 26 -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a notice, published in the Federal Register on March 26, 2024, entitled "AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of New Drug Application for LYNPARZA (Olaparib) Capsules."
The notice was issued by Lauren K. Roth, Associate Commissioner for Policy.
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SUMMARY:
The Food and Drug Administration (FDA or Agency) is withdrawing approval of new drug application (NDA) fo
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