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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 takes steps to encourage more informative labeling on prescription drug and biological products' indications and usage 06 July 2018
FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy 25 June 2018
FDA takes steps to foster greater efficiency in biosimilar development by reconsidering draft guidance on evaluating analytical studies 21 June 2018
FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales 05 June 2018
FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment 05 June 2018
FDA takes new steps to advance digital health, opening docket to solicit feedback on software products 29 May 2018
FDA approves novel preventive treatment for migraine 18 May 2018
FDA approves first epoetin alfa biosimilar for the treatment of anemia 15 May 2018
FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients 11 May 2018
FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia 19 April 2018
FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems 11 April 2018
FDA approves new treatment for certain digestive tract cancers 26 January 2018
FDA approves first treatment for breast cancer with a certain inherited genetic mutation 12 January 2018
FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response 22 December 2017
FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss 19 December 2017
FDA launches new tool for sharing information that allows doctors to better manage antibiotic use; improve patient care 13 December 2017
FDA launches public education campaign to encourage adult smokers trying to quit cigarettes 11 December 2017
FDA approves first biosimilar for the treatment of certain breast and stomach cancers 01 December 2017
FDA approves pill with sensor that digitally tracks if patients have ingested their medication 14 November 2017
FDA approves first treatment for certain patients with Erdheim-Chester Disease, a rare blood cancer 07 November 2017
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Business & Industry

  • 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
  • AstraZeneca launches call for entries to the 2023 global R&D Postdoctoral Challenge
  • Pfizer invests $43 billion to battle cancer

Research & Development

  • '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
  • Engineered bacteria find tumors, then alert the authorities
  • First nasal monoclonal antibody treatment for COVID-19 shows promise for treating virus, other diseases

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 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
  • FDA approves first treatment for Acid Sphingomyelinase Deficiency, a rare genetic disease
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