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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 targets unlawful internet sales of illegal prescription medicines during International Operation Pangea IX 10 June 2016
FDA approves first buprenorphine implant for treatment of opioid dependence 26 May 2016
FDA approves new treatment for inhalation anthrax 22 March 2016
FDA takes additional action to better understand safety of Essure, inform patients of potential risks 01 March 2016
FDA providing $2 million in new grants for natural history studies in rare diseases 29 February 2016
FDA seeks $5.1 billion total for FY 2017 10 February 2016
Califf, FDA top officials call for sweeping review of agency opioids policies 04 February 2016
FDA approves first drug to show survival benefit in liposarcoma 28 January 2016
FDA approves first drug to treat a rare enzyme disorder in pediatric and adult patients 08 December 2015
FDA approves Opdivo to treat advanced form of kidney cancer 24 November 2015
FDA approves new treatment for HIV 06 November 2015
FDA approves Praxbind, the first reversal agent for the anticoagulant Pradaxa 19 October 2015
FDA approves new injectable drug to treat schizophrenia 09 October 2015
FDA approves Keytruda for advanced non-small cell lung cancer 05 October 2015
FDA approves first treatment for sexual desire disorder 19 August 2015
FDA takes action to protect consumers from potentially dangerous counterfeit medicines and devices sold online 03 July 2015
FDA approves anti-clotting drug Savaysa 15 January 2015
FDA warns consumers about fraudulent Ebola treatment products 14 August 2014
FDA issues guidance to support the responsible development of nanotechnology products 25 June 2014
FDA launches openFDA to provide easy access to valuable FDA public data 13 June 2014
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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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