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  1. News & Events for Human Drugs

Notable Approvals | Drugs

News about human drug-related approvals

 

Title Date Brand Name Active Ingredient
FDA approves naloxone injection to counteract opioid overdoses 10/15/2021 ZIMHI naloxone hydrochloride
FDA approves add-on drug for adults with rare form of blood vessel inflammation 10/13/2021 Tavneos avacopan
FDA approves add-on drug for ages 10 & up with rare forms of high cholesterol  9/24/2021 Repatha evolocumab
FDA approves new use of transplant drug based on real-world evidence 7/16/2021 Prograf tacrolimus
FDA approves drug to reduce risk of serious kidney and heart complications in adults with chronic kidney disease associated with type 2 diabetes  7/9/2021 Kerendia finerenone
FDA approves therapy for pediatric patients with serious rare blood disease 6/7/2021 Ultomiris ravulizumab-cwvz
FDA approves drug to treat smallpox 6/4/2021 Tembexa brincidofovir
FDA approves second PSMA-targeted PET imaging drug for men with prostate cancer 5/27/2021 Pylarify piflufolastat F 18
FDA approves new treatment for adults with serious rare blood disease 5/14/021 Empaveli pegcetacoplan
FDA approves add-on therapy for patients with genetic form of severely high cholesterol 4/1/2021 Praluent alirocumab
FDA approves first treatment for disease that causes recurrent inflammation in sac surrounding heart 3/18/2021 Arcalyst rilonacept
FDA approves add-on therapy for patients with genetic form of severely high cholesterol 2/11/2021 Evkeeza evinacumab-dgnb
FDA approves treatment for ebola virus 12/21/2020 Ebanga ansuvimab-zykl
FDA approves weight management drug for patients aged 12 and older  12/4/2020 Saxenda liraglutide
FDA approves first treatment for weight management for people with certain rare genetic conditions  11/27/2020 Imcivree setmelanotide
FDA’s approval of Veklury (remdesivir) for the treatment of COVID-19—the science of safety and effectiveness 10/22/2020 Veklury remdesivir
FDA approves weekly therapy for adult growth hormone deficiency 9/1/2020 Sogroya somapacitan
FDA approves new treatment for rare hereditary disease 8/23/2018 Takhzyro lanadelumab

Related Resources

  • FDA Newsroom - more information about other drug approvals 
  • Drugs@FDA - search individual drugs on FDA database
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