| 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 |
3/05/2024 |
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 |
| 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 |
