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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 first systemic treatment for alopecia areata 13 June 2022
FDA urges drug manufacturers to develop risk management plans to promote a dtronger, resilient drug supply chain 19 May 2022
FDA limits use of Janssen COVID-19 vaccine to certain individuals 06 May 2022
FDA approves first generic of Symbicort to treat asthma and COPD 15 March 2022
FDA approves treatment for wider range of patients with heart failure 24 February 2022
FDA takes key action by approving second COVID-19 vaccine 31 January 2022
FDA authorizes additional oral antiviral for treatment of COVID-19 in certain adults 27 December 2021
FDA authorizes first oral antiviral for treatment of COVID-19 22 December 2021
FDA expands eligibility for Pfizer-BioNTech COVID-19 booster dose to 16- and 17-year-olds 09 December 2021
FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in children 5 through 11 years of age 29 October 2021
FDA, NIH, and 15 private organizations join forces to increase effective gene therapies for rare diseases 28 October 2021
FDA takes additional actions on the use of a booster dose for COVID-19 vaccines 21 October 2021
FDA awards 11 grants to clinical trials to develop new medical products for rare disease treatments 14 October 2021
FDA approves innovative treatment for pediatric patients with congenital athymia 08 October 2021
FDA authorizes software that can help identify prostate cancer 21 September 2021
FDA advances data, IT modernization efforts with new office of digital transformation 15 September 2021
FDA approves first COVID-19 vaccine 24 August 2021
FDA approves new treatment for Pompe disease 06 August 2021
FDA approves first interchangeable biosimilar insulin product for treatment of diabetes 29 July 2021
FDA approves first oral blood thinning medication for children 22 June 2021
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Business & Industry

  • Bayer opens new Research & Innovation Center in Boston-Cambridge demonstrating its commitment to precision oncology
  • New Novartis extension phase data show nearly 80% of RMS patients treated with Kesimpta® (ofatumumab) had no evidence of disease activity (NEDA-3)
  • Pfizer and BioNTech announce Omicron-adapted COVID-19 vaccine candidates demonstrate high immune response against Omicron
  • GSK announces £1 billion R&D investment over ten years to get ahead of infectious diseases in lower-income countries
  • Novartis announces Nature Medicine publication of Zolgensma data demonstrating age-appropriate milestones when treating children with SMA presymptomatically

Research & Development

  • Oral antiviral drug effective against respiratory syncytial virus (RSV) identified by researchers
  • Biomarkers found that could be drug targets against a deadly form of brain cancer
  • COVID-19 rebound after taking Paxlovid likely due to insufficient drug exposure
  • Novel drug combo activates natural killer cell immunity to destroy cancer cells
  • Broadly neutralizing antibodies could provide immunity against SARS-CoV-2 variants
  • A new technology offers treatment for HIV infection through a single injection
  • Proteomic study of 2,002 tumors identifies 11 pan-cancer molecular subtypes across 14 types of cancer

Conferences & Events

  • New approach to treatment of deadly kidney cancer
  • SAE Media Group proudly presents the 2nd Annual Aseptic Processing Conference
  • 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

Regulatory Affairs

  • FDA approves first systemic treatment for alopecia areata
  • 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
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