FDA News

FDA Improves Access to Reports of Adverse Drug Reactions

The U.S. Food and Drug Administration today launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to access this …

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FDA Approves Lilly’s Verzenio for Treatment of Advanced or Metastatic Breast Cancer

The U.S. Food and Drug Administration today approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient’s hormones (endocrine therapy). Verzenio is approved to be given …

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FDA Grants Priority Review for Genentech’s Perjeta for HER2-Positive Early Breast Cancer

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Perjeta® (pertuzumab), in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen), for …

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FDA Commissioner Gottlieb on New Efforts to Encourage Compounding of Better Quality Drugs Under DQSA

As a physician, I understand how important it is for health care providers to have access to compounded drugs when the needs of their patients cannot be met by FDA-approved drugs. Our commitment to implementing and enforcing the Drug Quality and Security Act (DQSA) provides a pivotal foundation for achieving …

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FDA Accepts sNDA for Eisai’s Lenvatinib for the Treatment of Hepatocellular Carcinoma

WOODCLIFF LAKE, N.J., Sept. 26, 2017 /PRNewswire/ — Eisai Inc. today announced the U.S. Food and Drug Administration (FDA) accepted for review a supplemental New Drug Application (sNDA) for lenvatinib (marketed as Lenvima®) for the potential use in the first-line treatment of patients with hepatocellular carcinoma (HCC), commonly referred to as liver cancer. …

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FDA Grants Orphan Drug Designation to PhaseRx’s Rare Liver Disease Drug

SEATTLE, Sept. 20, 2017 /PRNewswire/ — PhaseRx, Inc. (NASDAQ: PZRX), a biopharmaceutical company developing mRNA treatments for life-threatening inherited liver diseases in children, today announced that its second drug development candidate, PRX-ASL, for the treatment of argininosuccinate lyase deficiency (ASLD), has received orphan drug designation by the U.S. Food and …

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FDA Advisory Committee Split on Opinion of Adjuvant Sutent for High-Risk Renal Cell Carcinoma

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) voted 6 in favor and 6 against the benefit-risk profile for SUTENT® (sunitinib) as adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy (surgical …

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AbbVie Announces Positive Results from Late-Stage Relapsed/Refractory Chronic Lymphocytic Leukemia Study

NORTH CHICAGO, Ill., Sept. 18, 2017 /PRNewswire/ — AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced that the Phase 3 MURANO study of VENCLEXTA™/VENCLYXTO™ (Venetoclax) Tablets in combination with Rituxan® (rituximab) met its primary endpoint. Results showed that VENCLEXTA/VENCLYXTO in combination with Rituxan prolonged progression-free survival (PFS) in patients with relapsed/refractory (R/R) chronic …

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FDA Approves Bayer’s Aliqopa for Treatment of Relapsed Follicular Lymphoma

WHIPPANY, N.J., Sept. 14, 2017 /PRNewswire/ — Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Aliqopa™ (copanlisib) for the treatment of adult patients with relapsed FL who have received at least two prior systemic therapies.1 Accelerated approval was granted for this indication based on ORR. …

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FDA Approves Amgen and Allergan’s Mvasi for the Treatment of Five Types of Cancer

THOUSAND OAKS, Calif., Sept. 14, 2017 /PRNewswire/ — Amgen (NASDAQ: AMGN) and Allergan plc. (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved MVASI™ (bevacizumab-awwb) for all eligible indications of the reference product, Avastin® (bevacizumab). MVASI is the first anti-cancer biosimilar, as well as the first bevacizumab biosimilar, approved by the FDA. MVASI is …

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