Notable Approvals | Drugs

FDA approves imaging drug for evaluation of myocardial ischemia and infarction 9/27/2024 Flyrcado flurpiridaz F 18 FDA approves new drug for hypoparathyroidism, a rare disorder 8/12/2024 Yorvipath palopegteriparatide FDA approves treatment for adults with Alzheimer’s disease 7/02/2024 Kisunla donanemab-azbt FDA approves treatment for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults 6/24/2024 Vyvgart Hytrulo efgartigimod alfa and hyaluronidase-qvfc FDA approves first interchangeable biosimilars to Eylea to treat macular degeneration and other eye conditions 5/20/2024 Yesafili and Opuviz aflibercept-jbvf and aflibercept-yszy FDA approves first drug for WHIM syndrome, a rare disorder 4/29/2024 Xolremdi mavorixafor FDA approves imaging drug to assist in detection of cancerous tissue following lumpectomy 4/17/2024 Lumisight pegulicianine FDA approves first interchangeable biosimilars to Prolia and Xgeva to treat certain types of osteoporosis and prevent bone events in cancer 3/5/2024 Jubbonti and Wyost Denosumab-bbdz FDA approves new drug under special pathway for patients receiving hemodialysis 11/15/2023 Defencath taurolidine and heparin FDA approves first biosimilar to Actemra to treat adult and pediatric arthritis 9/29/2023 Tofidence tocilizumab-bavi FDA approves multiple generics of ADHD and BED treatment 8/28/2023 Vyvanse lisdexamfetamine dimesylate FDA approves first treatment for CD55-deficient protein-losing enteropathy (CHAPLE disease) 8/18/2023 Veopoz pozelimab-bbfg FDA approves first treatment for Fibrodysplasia Ossificans Progressiva 8/17/2023 Sohonos palovarotene FDA approves first treatment for molluscum contagiosum 7/24/2023 Ycanth cantharidin FDA approves first treatment for pediatric functional constipation 6/12/2023 Linzess linaclotide FDA approves treatment for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma 5/19/2023 Epkinkly epcoritamab-bysp FDA approves first oral treatment for moderately to severely active Crohn’s disease 5/18/2023 Rinvoq upadacitinib FDA approves treatment of amyotrophic lateral sclerosis associated with a mutation in the SOD1 gene 4/25/2023 Qalsody tofersen FDA approves first treatment for activated phosphoinositide 3-kinase delta syndrome 3/24/2023 Joenja leniolisib FDA approves first treatment for Rett Syndrome 3/13/2023 Daybue trofinetide FDA approves first treatment for Friedreich’s ataxia 2/28/2023 Skyclarys omaveloxolone FDA approves first enzyme replacement therapy for rare alpha-mannosidosis 2/17/2023 Lamzede velmanase alfa-tycv FDA approves drug combination treatment for adults with asthma 1/10/2023 Airsupra albuterol-budesonide FDA approves imaging drug to help identify lung cancer lesions 12/16/2022 Cytalux pafolacianine FDA approves first treatment for prurigo nodularis 9/28/2022 Dupixent dupilumab FDA approves treatment to improve kidney function in adults with hepatorenal syndrome 9/14/2022 Terlivaz terlipressin FDA approves topical treatment addressing repigmentation in vitiligo in patients aged 12 and older 7/19/2022 Opzelura ruxolitinib FDA approves treatment for chronic weight management in pediatric patients aged 12 years and older 6/24/2022 Qsymia phentermine and topiramate FDA approves treatment for weight management in patients with Bardet-Biedl Syndrome aged 6 or older 6/16/2022 Imcivree setmelanotide FDA Approves Oral Form for the treatment of adults with amyotrophic lateral sclerosis (ALS) 5/12/2022 Radicava ORS edaravone FDA approves new drug to improve heart function in adults with rare heart condition 4/29/2022 Camzyos mavacamten FDA approves drug for treatment of seizures associated with rare disease in patients two years of age and older 3/18/2022 Ztalmy ganaxolone FDA approves drug for adults with rare form of bone marrow disorder 2/28/2022 Vonjo pacritinib FDA approves treatment for anemia in adults with rare inherited disorder 2/17/2022 Pyrukynd mitapivat FDA approves treatment for adults with rare type of anemia 2/4/2022 Enjaymo sutimlimab-jome FDA approves add-on therapy to lower cholesterol among certain high-risk adults 12/22/2021 Leqvio inclisiran FDA approves drug to treat, help prevent types of blood clots in certain pediatric populations 12/20/2021 Xarelto rivaroxaban FDA approves Tezspire as maintenance treatment for severe asthma 12/17/2021 Tezspire tezepelumab-ekko FDA approves drug to treat sickle cell disease in patients aged 4 up to 11 years 12/17/2021 Oxbryta voxelotor FDA approves first drug to decrease urine protein in IgA nephropathy, a rare kidney disease 12/15/2021 Tarpeyo budesonide 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 5/14/2021 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

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