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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 launches global operation to crack down on websites selling illegal, potentially dangerous drugs 23 October 2018
FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old 08 October 2018
FDA approves first treatment for advanced form of the second most common skin cancer 28 September 2018
FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases 24 September 2018
FDA approves new kind of treatment for hairy cell leukemia 13 September 2018
FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease 10 August 2018
FDA approves treatment for two rare types of non-Hodgkin lymphoma 08 August 2018
FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation 20 July 2018
FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency 18 July 2018
FDA warns of imposters sending consumers fake warning letters 13 July 2018
FDA takes steps to encourage more informative labeling on prescription drug and biological products' indications and usage 06 July 2018
FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy 25 June 2018
FDA takes steps to foster greater efficiency in biosimilar development by reconsidering draft guidance on evaluating analytical studies 21 June 2018
FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales 05 June 2018
FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment 05 June 2018
FDA takes new steps to advance digital health, opening docket to solicit feedback on software products 29 May 2018
FDA approves novel preventive treatment for migraine 18 May 2018
FDA approves first epoetin alfa biosimilar for the treatment of anemia 15 May 2018
FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients 11 May 2018
FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia 19 April 2018
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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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