FDA News

FDA Grants Accelerated Approval to Padcev for Treatment of Locally Advanced or Metastatic Urothelial Cancer

BOTHELL, Wash. & TOKYO–(BUSINESS WIRE)–Seattle Genetics, Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to PADCEV™ for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a …

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FDA Advisory Committee Votes Unanimously in Favor of Epizyme’s Tazemetostat for the Treatment of Patients with Epithelioid Sarcoma

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, today announced that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) voted 11 – 0 in favor of the benefit-risk profile of tazemetostat as a treatment for patients with metastatic …

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FDA Grants Priority Review to sNDA for Braftovi Plus Erbitux for the Treatment of Certain Patients with Metastatic Colorectal Cancer

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to the Company’s supplemental New Drug Application (sNDA) for BRAFTOVI® (encorafenib) in combination with ERBITUX® (cetuximab) (BRAFTOVI Doublet) based on results from the Phase 3 BEACON CRC trial, which evaluated …

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FDA Grants Breakthrough Therapy Designation to Seattle Genetics’ Tucatinib for Advanced HER2-Positive Breast Cancer

BOTHELL, Wash.–(BUSINESS WIRE)–Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tucatinib, in combination with trastuzumab and capecitabine, for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have been treated …

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Keytruda Recommended by the FDA Advisory Committee for Treatment of Certain Patients with Non-Muscle Invasive Bladder Cancer

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) voted 9-4 in favor of recommending KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of certain patients with high-risk, non-muscle invasive …

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FDA Advisory Committee Recommends Approval for Lynparza for First-Line Maintenance Therapy in BRCA-Mutated Metastatic Pancreatic Cancer

KENILWORTH, N.J.–(BUSINESS WIRE)–AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 7-5 to recommend LYNPARZA as a first-line maintenance monotherapy for patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the …

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FDA Approves sNDA for Xtandi for Treatment of Patients with Metastatic Castration-Sensitive Prostate Cancer

NEW YORK & TOKYO–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) for the treatment of patients with metastatic castration-sensitive prostate …

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Deciphera Submits Ripretinib NDA to the FDA for Treatment of Patients with Advanced Gastrointestinal Stromal Tumors

WALTHAM, Mass.–(BUSINESS WIRE)–Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ripretinib, the Company’s investigational broad-spectrum KIT and PDGFRα inhibitor, for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib …

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FDA Expands Approval of Amarin’s Vascepa to Reduce Cardiovascular Risk

DUBLIN, Ireland and BRIDGEWATER, N.J., Dec. 13, 2019 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ: AMRN) today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication and label expansion for VASCEPA® (icosapent ethyl) capsules. After more than a decade of development and testing, VASCEPA is now …

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FDA Advisory Committee Votes Unanimously to Support the Use of Teprotumumab for the Treatment of Thyroid Eye Disease

DUBLIN–(BUSINESS WIRE)–Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) of the U.S. Food and Drug Administration (FDA) voted unanimously that the potential benefits of teprotumumab, a fully human monoclonal antibody (mAb), outweigh the potential risks for the treatment of Thyroid Eye Disease …

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