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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 Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines 30 June 2020
FDA announces first of its kind pilot program to communicate patient reported outcomes from cancer clinical trials 24 June 2020
FDA revokes emergency use authorization for chloroquine and hydroxychloroquine 15 June 2020
FDA takes new actions to accelerate development of novel prevention, treatment options for COVID-19 12 May 2020
FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment 01 May 2020
FDA reiterates importance of close patient supervision for 'off-label' use of antimalarial drugs 24 April 2020
FDA encourages recovered patients to donate plasma for development of blood-related therapies 16 April 2020
FDA Coordinates National Effort to Develop Blood-Related Therapies for COVID-19 03 April 2020
FDA Continues to Accelerate Development of Novel Therapies for COVID-19 01 April 2020
The FDA is facilitating access to convalescent plasma collected from recovered COVID-19 patients 25 March 2020
FDA continues to facilitate development of COVID-19 treatments 20 March 2020
FDA and FTC warn seven companies selling fraudulent products that claim to treat or prevent COVID-19 09 March 2020
FDA approves new treatment for adults with Cushing's disease 06 March 2020
FDA approves first generic of Daraprim 28 February 2020
FDA takes action with Indian Government to protect consumers from illicit medical products 18 February 2020
FDA approves first drug for treatment of peanut allergy for children 31 January 2020
FDA continues strong support of innovation in development of gene therapy products 29 January 2020
FDA approves first treatment option specifically for patients with epithelioid sarcoma 24 January 2020
FDA approves first treatment for thyroid eye disease 21 January 2020
FDA approves the first targeted therapy to treat a rare mutation in patients with gastrointestinal stromal tumors 10 January 2020
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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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