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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 treatment for severe hypoglycemia that can be administered without an injection 25 July 2019
FDA approves first generics of Lyrica 22 July 2019
FDA approves new treatment for refractory multiple myeloma 03 July 2019
FDA approves first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system 27 June 2019
FDA seeks public feedback on new drug approval transparency efforts 26 June 2019
FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma 10 June 2019
FDA announces Project Facilitate to assist physicians seeking access to unapproved therapies for patients with cancer 03 June 2019
FDA approves first anticoagulant (blood thinner) for pediatric patients to treat potentially life-threatening blood clots 16 May 2019
FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome 09 May 2019
FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis 06 May 2019
FDA approves first treatment for pediatric patients with lupus 26 April 2019
FDA permits marketing of first medical device for treatment of ADHD 23 April 2019
FDA approves first generic naloxone nasal spray to treat opioid overdose 19 April 2019
FDA approves first targeted therapy for metastatic bladder cancer 15 April 2019
FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture 10 April 2019
FDA expands approved use of metastatic breast cancer treatment to include male patients 04 April 2019
FDA approves treatment for patients with a type of inflammatory arthritis 28 March 2019
FDA approves a new generic valsartan 12 March 2019
FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor's office or clinic 06 March 2019
FDA takes new steps to adopt more modern technologies for improving the security of the drug supply chain 14 February 2019
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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 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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