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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 alerts health care providers of recall of anemia drug Omontys 24 February 2013
FDA approves Pomalyst for advanced multiple myeloma 10 February 2013
FDA approves Gleevec for children with acute lymphoblastic leukemia 27 January 2013
FDA approves new seasonal influenza vaccine made using novel technology 16 January 2013
FDA approves Eliquis to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation 01 January 2013
FDA expands use of Xarelto to treat, reduce recurrence of blood clots 04 November 2012
FDA takes action against thousands of illegal Internet pharmacies 04 October 2012
FDA approves new treatment for advanced colorectal cancer 27 September 2012
New FDA task force will support innovation in antibacterial drug development 24 September 2012
FDA approves Lucentis to treat diabetic macular edema 12 August 2012
FDA approves first generic versions of Singulair to treat asthma, allergies 05 August 2012
More than 150 antiretroviral drugs available through PEPFAR for worldwide HIV/AIDS relief 24 July 2012
FDA approves generic versions of blood thinner Plavix 21 May 2012
FDA issues alert on potential dangers of unproven treatment for multiple sclerosis 11 May 2012
FDA approves first Boniva generics to treat or prevent osteoporosis 19 March 2012
FDA announces safety changes in labeling for some cholesterol-lowering drugs 28 February 2012
FDA acts to bolster supply of critically needed cancer drugs 22 February 2012
FDA approves first generic version of cholesterol-lowering drug Lipitor 01 December 2011
Drug not Shown to be Safe and Effective in Breast Cancer Patients 21 November 2011
FDA begins process to remove breast cancer indication from Avastin label 16 December 2010
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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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