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FDA

The U.S. Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

www.fda.gov

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List of articles in category FDA
Title Published Date
FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems 11 April 2018
FDA approves new treatment for certain digestive tract cancers 26 January 2018
FDA approves first treatment for breast cancer with a certain inherited genetic mutation 12 January 2018
FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response 22 December 2017
FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss 19 December 2017
FDA launches new tool for sharing information that allows doctors to better manage antibiotic use; improve patient care 13 December 2017
FDA launches public education campaign to encourage adult smokers trying to quit cigarettes 11 December 2017
FDA approves first biosimilar for the treatment of certain breast and stomach cancers 01 December 2017
FDA approves pill with sensor that digitally tracks if patients have ingested their medication 14 November 2017
FDA approves first treatment for certain patients with Erdheim-Chester Disease, a rare blood cancer 07 November 2017
FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer 01 November 2017
FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma 20 October 2017
FDA awards 15 grants for clinical trials to stimulate product development for rare diseases 06 October 2017
FDA awards six grants for natural history studies in rare diseases 06 October 2017
FDA improves access to reports of adverse drug reactions 28 September 2017
FDA conducts major global operation to protect consumers from potentially dangerous prescription drugs sold online 26 September 2017
FDA approves first biosimilar for the treatment of cancer 14 September 2017
FDA approves Mylotarg for treatment of acute myeloid leukemia 01 September 2017
FDA approval brings first gene therapy to the United States 30 August 2017
FDA approves first U.S. treatment for Chagas disease 30 August 2017
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Health data interoperability: Opportunities and threats

Business & Industry

  • Valneva switches focus to bilateral discussions to supply its inactivated, adjuvanted COVID-19 vaccine candidate VLA2001
  • Pfizer and BioNTech to supply the European Union with 100 million additional doses of COMIRNATY®
  • Amgen successfully completes acquisition of Five Prime Therapeutics
  • GSK and Vir Biotechnology announce EMA review of dual-action monoclonal antibody VIR-7831 for the early treatment of COVID-19
  • Phase III prevention trial showed subcutaneous administration of investigational antibody cocktail casirivimab and imdevimab reduced risk of symptomatic COVID-19 infections by 81%

Research & Development

  • Differing immune responses discovered in asymptomatic cases vs those with severe COVID-19
  • Patients who are obese or overweight are at risk for a more severe course of COVID-19
  • New COVID-19 vaccine may offer broad protection from coronaviruses
  • SARS-CoV-2: New findings on the persistence of neutralizing antibodies
  • Massive fragment screen points way to new SARS-CoV-2 inhibitors
  • B.1.1.7. variant more transmissible, does not increase severity, Lancet studies suggest
  • COVID-19 causes 'unexpected' cellular response in the lungs

Conferences & Events

  • Scientists urge for investment now in highly potent vaccines to prevent the next pandemic
  • CPhI Worldwide to return in 2021
  • Reuters Events' Cell & Gene Therapy USA
  • Total health: Build a better healthcare system
  • Don't fall for the 'next best action' trap
  • Locking down shape-shifting spike protein aids development of COVID-19 vaccine
  • COVID-19 vaccine innovation could dramatically speed up worldwide production

Regulatory Affairs

  • FDA revokes emergency use authorization for monoclonal antibody Bamlanivimab
  • Joint CDC and FDA statement on Johnson & Johnson COVID-19 vaccine
  • AstraZeneca's COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
  • Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna
  • EMA's safety committee continues investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events
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