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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 novel treatment to target abnormality in sickle cell disease 25 November 2019
FDA approves first treatment for inherited rare disease 20 November 2019
FDA approves first targeted therapy to treat patients with painful complication of sickle cell disease 15 November 2019
FDA approves first therapy to treat patients with rare blood disorder 08 November 2019
Digital submission of adverse event reports for investigational new drug applications 29 October 2019
FDA approves new treatment for patients with migraine 11 October 2019
FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases 08 October 2019
FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic 03 October 2019
FDA announces voluntary recall of Sandoz ranitidine capsules following detection of an impurity 24 September 2019
FDA approves first oral GLP-1 treatment for type 2 diabetes 20 September 2019
FDA takes first action under new international collaboration with Australia and Canada 17 September 2019
FDA approves first treatment for patients with rare type of lung disease 09 September 2019
FDA approves new drug for treatment-resistant forms of tuberculosis that affects the lungs 15 August 2019
FDA approves first therapy for rare joint tumor 02 August 2019
FDA approves first treatment for severe hypoglycemia that can be administered without an injection 25 July 2019
FDA approves first generics of Lyrica 22 July 2019
FDA approves new treatment for refractory multiple myeloma 03 July 2019
FDA approves first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system 27 June 2019
FDA seeks public feedback on new drug approval transparency efforts 26 June 2019
FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma 10 June 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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