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Editorial & Opinion

The Next Chapter of Renal Denervation After US Food and Drug Administration Approval.

  • Authors : Vongpatanasin W; Hypertension Section (W.V.), Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas.; Cardiology Division (W.V., T.A.)., Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas.

Subjects: United States Food and Drug Administration*; United States ; Humans

  • Source: Circulation [Circulation] 2024 Mar 05; Vol. 149 (10), pp. 760-763. Date of Electronic Publication: 2024 Mar 04.Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 0147763

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Academic Journal

US Food and Drug Administration Approval Summary: Talazoparib in Combination With Enzalutamide for Treatment of Patients With Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer.

  • Authors : Heiss BL; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.; Chang E

Subjects: Prostatic Neoplasms, Castration-Resistant*/Prostatic Neoplasms, Castration-Resistant*/Prostatic Neoplasms, Castration-Resistant*/drug therapy ; Prostatic Neoplasms, Castration-Resistant*/Prostatic Neoplasms, Castration-Resistant*/Prostatic Neoplasms, Castration-Resistant*/genetics ; Prostatic Neoplasms, Castration-Resistant*/Prostatic Neoplasms, Castration-Resistant*/Prostatic Neoplasms, Castration-Resistant*/pathology

  • Source: Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2024 May 20; Vol. 42 (15), pp. 1851-1860. Date of Electronic Publication: Publisher: American Society of Clinical Oncology Country of Publication: United States NLM ID: 8309333

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Academic Journal

Second primary malignancies after commercial CAR T-cell therapy: analysis of the FDA Adverse Events Reporting System.

  • Authors : Elsallab M; Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA.; Cellular Immunotherapy Program, Mass General Cancer Center, and Department of Medicine, Harvard Medical School, Boston, MA.

Subjects: Neoplasms, Second Primary*/Neoplasms, Second Primary*/Neoplasms, Second Primary*/etiology ; Neoplasms, Second Primary*/Neoplasms, Second Primary*/Neoplasms, Second Primary*/therapy ; Neoplasms, Second Primary*/Neoplasms, Second Primary*/Neoplasms, Second Primary*/epidemiology

  • Source: Blood [Blood] 2024 May 16; Vol. 143 (20), pp. 2099-2105.Publisher: Elsevier Country of Publication: United States NLM ID: 7603509 Publication Model:

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Academic Journal

How New Regulation of Laboratory-Developed Antimicrobial Susceptibility Tests Will Affect Infectious Diseases Clinical Practice.

  • Authors : Wolfe KH; Department of Infectious Diseases, Vanderbilt University Medical Center, Nashville, Tennessee.; Pierce VM

Subjects: United States Food and Drug Administration* ; Microbial Sensitivity Tests*/Microbial Sensitivity Tests*/Microbial Sensitivity Tests*/standards ; Microbial Sensitivity Tests*/Microbial Sensitivity Tests*/Microbial Sensitivity Tests*/methods

  • Source: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2024 May 15; Vol. 78 (5), pp. 1140-1147.Publisher: Oxford University Press Country of Publication: United States NLM ID: 9203213 Publication

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Academic Journal

FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma.

  • Authors : Maguire WF; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Lee D

Subjects: Antibodies, Monoclonal, Humanized*/Antibodies, Monoclonal, Humanized*/Antibodies, Monoclonal, Humanized*/administration & dosage ; Antibodies, Monoclonal, Humanized*/Antibodies, Monoclonal, Humanized*/Antibodies, Monoclonal, Humanized*/adverse effects ; Antibodies, Monoclonal, Humanized*/Antibodies, Monoclonal, Humanized*/Antibodies, Monoclonal, Humanized*/therapeutic use

  • Source: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2024 May 15; Vol. 30 (10), pp. 2011-2016.Publisher: The Association Country of Publication: United States NLM ID: 9502500 Publication Model:

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Academic Journal

Understanding the Impacts of the Supreme Court Case FDA v Alliance for Hippocratic Medicine.

Subjects: Supreme Court Decisions* ; United States Food and Drug Administration*/United States Food and Drug Administration*/United States Food and Drug Administration*/legislation & jurisprudence ; Mifepristone*/Mifepristone*/Mifepristone*/therapeutic use

  • Source: JAMA [JAMA] 2024 May 14; Vol. 331 (18), pp. 1529-1530.Publisher: American Medical Association Country of Publication: United States NLM ID: 7501160

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Academic Journal

Impact of FDA's HCT/P ZIKV Recommendations on Cord Blood Unit Eligibility and Utilization in a Large Public Cord Blood Bank.

Subjects: United States Food and Drug Administration* ; Zika Virus Infection*/Zika Virus Infection*/Zika Virus Infection*/transmission ; Fetal Blood*/Fetal Blood*/Fetal Blood*/virology

  • Source: Stem cells translational medicine [Stem Cells Transl Med] 2024 May 14; Vol. 13 (5), pp. 448-453.Publisher: Oxford University Press Country of Publication: England NLM ID: 101578022 Publication Model: Print Cited Medium: Internet ISSN:

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Academic Journal

Safety analysis of Oseltamivir and Baloxavir Marboxil after market approval: a pharmacovigilance study based on the FDA adverse event reporting system.

  • Authors : Li Y; Department of Pharmacy, Women and Children's Hospital, School of Medicine, Xiamen University, 10# Zhenhai Road, Xiamen, China.; Wang X

Subjects: Dibenzothiepins*/Dibenzothiepins*/Dibenzothiepins*/adverse effects ; Triazines*/Triazines*/Triazines*/adverse effects ; Oseltamivir*/Oseltamivir*/Oseltamivir*/adverse effects

  • Source: BMC infectious diseases [BMC Infect Dis] 2024 May 09; Vol. 24 (1), pp. 446. Date of Electronic Publication: 2024 May 09.Publisher: BioMed Central Country of Publication: England NLM ID: 100968551 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2334

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Academic Journal

FDA's proposed rule and its regulatory impact on emerging and reemerging neglected tropical diseases in the United States.

  • Authors : Paniz-Mondolfi AE; Molecular Microbiology Laboratory, Department of Pathology, Molecular and Cell-Based Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, United States of America.; Ramírez JD

Subjects: Neglected Diseases*/Neglected Diseases*/Neglected Diseases*/epidemiology ; United States Food and Drug Administration*/United States Food and Drug Administration*/United States Food and Drug Administration*/legislation & jurisprudence ; Communicable Diseases, Emerging*/Communicable Diseases, Emerging*/Communicable Diseases, Emerging*/epidemiology

  • Source: PLoS neglected tropical diseases [PLoS Negl Trop Dis] 2024 May 09; Vol. 18 (5), pp. e0012116. Date of Electronic Publication: 2024 May 09 (Print Publication: 2024).Publisher: Public Library of Science Country of Publication: United States NLM ID: 101291488

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Academic Journal

Revolving doors: board memberships, hedge funds, and the FDA chiefs responsible for regulating industry.

Subjects: United States Food and Drug Administration*; United States ; Humans

  • Source: BMJ (Clinical research ed.) [BMJ] 2024 May 08; Vol. 385, pp. q975. Date of Electronic Publication: 2024 May 08.Publisher: British Medical Association Country of Publication: England NLM ID: 8900488 Publication Model: Electronic Cited Medium: Internet ISSN:

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  • 1-10 of  539,958 results for ""United States Food and Drug Administration""