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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 new steps to adopt more modern technologies for improving the security of the drug supply chain 14 February 2019
FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer's disease 11 February 2019
FDA approves first therapy for the treatment of adult patients with a rare blood clotting disorder 06 February 2019
FDA approves first generic Advair Diskus 31 January 2019
FDA approves first treatment for rare blood disease 21 December 2018
FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs 10 December 2018
FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder 30 November 2018
FDA approves new treatment for patients with acute myeloid leukemia 22 November 2018
FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot 19 November 2018
FDA highlights record-breaking number of generic drug approvals in October 09 November 2018
FDA approves new drug to treat influenza 26 October 2018
FDA launches global operation to crack down on websites selling illegal, potentially dangerous drugs 23 October 2018
FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old 08 October 2018
FDA approves first treatment for advanced form of the second most common skin cancer 28 September 2018
FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases 24 September 2018
FDA approves new kind of treatment for hairy cell leukemia 13 September 2018
FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease 10 August 2018
FDA approves treatment for two rare types of non-Hodgkin lymphoma 08 August 2018
FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation 20 July 2018
FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency 18 July 2018
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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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