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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 Proposes Withdrawal of Low Blood Pressure Drug 17 August 2010
FDA to Communicate Safety Monitoring Activities to Consumers and Health Care Professionals 16 June 2010
FDA: Rare Cases of Liver Injury Reported with Use of Xenical, Alli 27 May 2010
FDA Announces Collaboration with Drugs.com 27 May 2010
'Bad Ad Program' to Help Health Care Providers Detect, Report Misleading Drug Ads 14 May 2010
FDA Requests $4.03 Billion to Promote and Protect Public Health 03 February 2010
FDA Commissioner Addresses Nation's Healthcare Professionals on H1N1 Vaccine 12 November 2009
FDA Warns of Unapproved and Illegal H1N1 Drug Products Purchased Over the Internet 19 October 2009
FDA Marks 100th HIV/AIDS Drug Authorized for Purchase Under PEPFAR 07 October 2009
FDA: Cancer Warnings Required for TNF Blockers 04 August 2009
FDA Takes Actions on Darvon, Other Pain Medications Containing Propoxyphene 08 July 2009
FDA Approves Drug for Patients with Advanced Prostate Cancer 30 December 2008
FDA's Monthly Video Series Wins Award 16 December 2008
FDA Warns Public of Extortion Scam by FDA Impersonators 17 November 2008
FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer 07 November 2008
FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Unapproved Drugs 29 October 2008
FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers 15 September 2008
FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts 23 August 2008
FDA Issues Alert on Tussionex, a Long-Acting Prescription Cough Medicine Containing Hydrocodone 14 March 2008
FDA Licenses New Hemophilia Treatment 22 February 2008
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Health data interoperability: Opportunities and threats

Business & Industry

  • 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%
  • Pfizer and BioNTech request regulatory agencies expand emergency use of their COVID-19 vaccine to adolescents

Research & Development

  • 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
  • Clinical trial completion rates decline during COVID-19 pandemic

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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