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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 approves new treatment for patients with acute myeloid leukemia 22 November 2018
FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot 19 November 2018
FDA highlights record-breaking number of generic drug approvals in October 09 November 2018
FDA approves new drug to treat influenza 26 October 2018
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FDA takes steps to foster greater efficiency in biosimilar development by reconsidering draft guidance on evaluating analytical studies 21 June 2018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
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Business & Industry

  • Roche enters partnership with the Global Fund to support low- and middle-income countries in strengthening critical diagnostics infrastructure
  • Nearly 700,000 US hospitalizations and 110,000 deaths prevented from the Pfizer-BioNTech COVID-19 vaccine
  • Pfizer and BioNTech provide update on COVID-19 vaccine supply agreement with European Commission
  • Roche pledges to extend commitment to the World Federation of Hemophilia Humanitarian Aid Program to 2028
  • Pfizer to acquire Biohaven Pharmaceuticals

Research & Development

  • "Natural immunity" from omicron is weak and limited, study finds
  • mRNA booster vaccines may be a good investment in developing countries
  • Blocking spike captors to counter COVID
  • Recurring brain tumor growth is halted with new drug
  • Investigational COVID mucosal vaccine protects against disease and transmission
  • Using AI to analyze large amounts of biological data
  • Cognitive impairment from severe COVID-19 equivalent to 20 years of ageing, study finds

Conferences & Events

  • Pharma join together to achieve new standards in digital and patient innovation for clinical transformation
  • SMi's 22nd Annual Pain Therapeutics Conference
  • SMi Group Introduces the 4th Annual Injectable Drug Delivery Conference 2022
  • SMi's 5th Annual Pharmaceutical Microbiology East Coast Conference
  • SMi's 3rd Annual AI in Drug Discovery Conference
  • SMi's 6th Annual Highly Potent Active Pharmaceutical Ingredients
  • SMi's 9th Annual Conference Pre-Filled Syringes East Coast

Regulatory Affairs

  • FDA urges drug manufacturers to develop risk management plans to promote a dtronger, resilient drug supply chain
  • FDA limits use of Janssen COVID-19 vaccine to certain individuals
  • EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice
  • FDA approves first generic of Symbicort to treat asthma and COPD
  • FDA approves treatment for wider range of patients with heart failure
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