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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 announces Project Facilitate to assist physicians seeking access to unapproved therapies for patients with cancer 03 June 2019
FDA approves first anticoagulant (blood thinner) for pediatric patients to treat potentially life-threatening blood clots 16 May 2019
FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome 09 May 2019
FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis 06 May 2019
FDA approves first treatment for pediatric patients with lupus 26 April 2019
FDA permits marketing of first medical device for treatment of ADHD 23 April 2019
FDA approves first generic naloxone nasal spray to treat opioid overdose 19 April 2019
FDA approves first targeted therapy for metastatic bladder cancer 15 April 2019
FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture 10 April 2019
FDA expands approved use of metastatic breast cancer treatment to include male patients 04 April 2019
FDA approves treatment for patients with a type of inflammatory arthritis 28 March 2019
FDA approves a new generic valsartan 12 March 2019
FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor's office or clinic 06 March 2019
FDA takes new steps to adopt more modern technologies for improving the security of the drug supply chain 14 February 2019
FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer's disease 11 February 2019
FDA approves first therapy for the treatment of adult patients with a rare blood clotting disorder 06 February 2019
FDA approves first generic Advair Diskus 31 January 2019
FDA approves first treatment for rare blood disease 21 December 2018
FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs 10 December 2018
FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder 30 November 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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