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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 Coordinates National Effort to Develop Blood-Related Therapies for COVID-19 03 April 2020
FDA Continues to Accelerate Development of Novel Therapies for COVID-19 01 April 2020
The FDA is facilitating access to convalescent plasma collected from recovered COVID-19 patients 25 March 2020
FDA continues to facilitate development of COVID-19 treatments 20 March 2020
FDA and FTC warn seven companies selling fraudulent products that claim to treat or prevent COVID-19 09 March 2020
FDA approves new treatment for adults with Cushing's disease 06 March 2020
FDA approves first generic of Daraprim 28 February 2020
FDA takes action with Indian Government to protect consumers from illicit medical products 18 February 2020
FDA approves first drug for treatment of peanut allergy for children 31 January 2020
FDA continues strong support of innovation in development of gene therapy products 29 January 2020
FDA approves first treatment option specifically for patients with epithelioid sarcoma 24 January 2020
FDA approves first treatment for thyroid eye disease 21 January 2020
FDA approves the first targeted therapy to treat a rare mutation in patients with gastrointestinal stromal tumors 10 January 2020
FDA approves new treatment for adults with migraine 01 January 2020
FDA approves first generics of Eliquis 26 December 2019
FDA approves new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies 20 December 2019
FDA approves new type of therapy to treat advanced urothelial cancer 19 December 2019
FDA grants accelerated approval to first targeted treatment for rare Duchenne muscular dystrophy mutation 13 December 2019
FDA launches app for health care professionals 09 December 2019
FDA approves first generics of Gilenya 05 December 2019
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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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