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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 over-the-counter naloxone nasal spray 29 March 2023
FDA grants Accelerated Approval for Alzheimer's disease treatment 06 January 2023
FDA approves new HIV drug for adults with limited treatment options 22 December 2022
FDA approves first gene therapy for the treatment of high-risk, non-muscle-invasive bladder cancer 16 December 2022
FDA approves first gene therapy to treat adults with Hemophilia B 22 November 2022
FDA approves first treatment for Acid Sphingomyelinase Deficiency, a rare genetic disease 31 August 2022
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
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Business & Industry

  • Novartis shares Zolgensma long-term data demonstrating sustained durability up to 7.5 years post-dosing; 100% achievement of all assessed milestones in children treated prior to SMA symptom onset
  • CPHI Pharma Awards open to global innovators, scientists, entrepreneurs and social leaders
  • Insilico Medicine brings AI-powered "ChatPandaGPT" to its target discovery platform
  • BlueRock Therapeutics to incorporate wearable and invisible contactless digital health technologies from Rune Labs and Emerald Innovations in Parkinson's disease clinical trial
  • Novartis Tafinlar + Mekinist approved by FDA for pediatric patients with BRAF V600E low-grade glioma

Research & Development

  • Candidate found to inhibit malignant melanoma growth
  • A nasal spray protects against coronavirus infection - Effective also against recent immune-evasive variants
  • 'Biohybrid' device could restore function in paralysed limbs
  • Scientists use tardigrade proteins for human health breakthrough
  • DNA treatment could delay paralysis that strikes nearly all patients with ALS
  • Scientists reveal a potential new approach to treating liver cancer
  • Normalizing tumor blood vessels may improve immunotherapy against brain cancer

Conferences & Events

  • SAE Media Group proudly presents the 4th Annual AI in Drug Discovery Conference
  • SAE Media Group's 6th annual 3D Cell Culture Conference
  • CPHI Frankfurt returns to pre-pandemic strength as pharma industry booms again
  • 14th Annual RNA Therapeutics: Investigating the next generation of genetic medicine through RNA based therapies
  • CPHI Excellence in Pharma Award Winners 2022
  • CPHI Frankfurt Report predicts huge funding overhang to drive contract services growth
  • CPHI Frankfurt 2022: Global pharma confidence hits record high in the annual CPHI Pharma Index

Regulatory Affairs

  • FDA approves first over-the-counter naloxone nasal spray
  • FDA grants Accelerated Approval for Alzheimer's disease treatment
  • FDA approves new HIV drug for adults with limited treatment options
  • FDA approves first gene therapy for the treatment of high-risk, non-muscle-invasive bladder cancer
  • FDA approves first gene therapy to treat adults with Hemophilia B
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