2021 FDA Itsva Inobvumira Mushonga 1Q-3Q

Innovation inofambisa kufambira mberi.Kana zvasvika kune hunyanzvi mukugadzirwa kwemishonga mitsva uye kurapa zvipenyu zvigadzirwa, FDA's Center for Drug Evaluation and Research (CDER) inotsigira indasitiri yemishonga padanho rega rega rekuita.Nekunzwisisa kwayo kwesainzi inoshandiswa kugadzira zvigadzirwa zvitsva, nzira dzekuyedza nekugadzira, uye zvirwere nemamiriro ayo zvigadzirwa zvitsva zvakagadzirirwa kurapa, CDER inopa sainzi uye kuraira zano rinodiwa kuunza marapirwo matsva kumusika.
Kuvepo kwemishonga mitsva uye zvigadzirwa zvebhayoloji zvinowanzoreva nzira nyowani dzekurapa kuvarwere uye kufambira mberi mune zvehutano kuruzhinji rweAmerica.Nechikonzero ichi, CDER inotsigira hunyanzvi uye inoita basa rakakosha mukubatsira kusimudzira kuvandudzwa kwezvinodhaka.
Gore rega rega, CDER inobvumidza kuwanda kwemishonga mitsva uye zvigadzirwa zvebiological:
1. Zvimwe zvezvigadzirwa izvi zvigadzirwa zvitsva zvisati zvamboshandiswa mumakiriniki maitiro.Pazasi pane rondedzero yezvitsva zvemolecular uye zvitsva zvekurapa zvipenyu zvakabvumidzwa neCDER muna 2021. Iyi rondedzero haina mishonga yekudzivirira, allergenic zvigadzirwa, ropa uye zvigadzirwa zveropa, zvinobuda muplasma, cellular uye gene therapy zvigadzirwa, kana zvimwe zvigadzirwa zvakatenderwa muna 2021 by. iyo Center for Biologics Evaluation uye Tsvagiridzo.
2. Zvimwe zvakafanana, kana kuti zvine chekuita nezvigadzirwa zvakambobvumidzwa, uye vachakwikwidzana nezvigadzirwa izvozvo pamusika.Ona Drugs@FDA kuti uwane ruzivo nezvese emishonga inotenderwa neCDER uye zvigadzirwa zvebiological.
Mimwe mishonga inorongedzerwa senhengo nyowani dzemamorekuru ("NMEs") nechinangwa chekuongorora kweFDA.Zvizhinji zvezvigadzirwa izvi zvine zvikamu zvinoshanda zvisina kutenderwa neFDA kare, ingave sechinhu chimwe chemishonga kana sechikamu chemusanganiswa wechigadzirwa;zvigadzirwa izvi zvinowanzopa zvakakosha kurapa kutsva kune varwere.Mimwe mishonga inoratidzirwa seNMEs yezvinangwa zvekutonga, asi zvakadaro ine mitezo inoshanda inoenderana zvakanyanya neaya anoshanda muzvigadzirwa zvakambobvumidzwa neFDA.Semuyenzaniso, CDER inoisa zvigadzirwa zvebhayoloji zvakaunzwa mukunyorera pasi pechikamu 351 (a) chePublic Health Service Act seNMEs nechinangwa chekuongorora kweFDA, zvisinei nekuti Agency yakambobvumidza chikamu chinoshanda mune chimwe chigadzirwa chakasiyana.Kusarudzwa kweFDA kwemushonga se "NME" kwezvinangwa zvekuongorora kwakasiyana kubva kune FDA kutsunga kuti chigadzirwa chemushonga i "new chemical entity" kana "NCE" mukati mezvinoreva Federal Food, Drug, and Cosmetic Act.

Aihwa. Zita rezvinodhaka Active Ingredient Zuva Rokubvumirwa FDA-yakatenderwa kushandiswa pazuva rekubvumidzwa *
37 Exkivity mobocertinib 9/15/2021 Kurapa munharaunda yepamusoro kana metastatic isiri-diki cell kenza yemapapu ine epidermal kukura factor receptor exon 20 kuisa shanduko.
36 Skytrofa lonapegsomatropin-tcgd 8/25/2021 Kubata hupfupi nekuda kwekusakwana secretion ye endogenous growth hormone
35 Korsuva difelikefalin 8/23/2021 Kurapa pakati-kusvika-yakanyanya pruritus yakabatana nechirwere cheitsvo chisingaperi mune vamwe vanhu
34 Welireg belzutifan 8/13/2021 Kurapa chirwere chevon Hippel-Lindau pasi pemamwe mamiriro
33 Nexviazyme avalglucosidase alfa-ngpt 8/6/2021 Kurapa kunonoka-kutanga Pompe chirwere
Press Release
32 Saphnelo anifrolumab-fnia 7/30/2021 Kurapa zvine mwero-kusvika kuomarara systemic lupus erythematousus pamwe neyakajairwa kurapa
31 Bylvay odevixibat 7/20/2021 Kurapa pruritus
30 Rezurock belumosudil 7/16/2021 Kurapa chirwere chisingaperi chegraft-versus-host chirwere mushure mekukundikana kweinenge mbiri mitsetse yekutanga ye systemic therapy
29 fexidazole fexidazole 7/16/2021 Kurapa vanhu vemuAfrica trypanosomiasis inokonzerwa neparasite Trypanosoma brucei gambiense
28 Kerendia finerenone 7/9/2021 Kuti uderedze njodzi yeitsvo uye yemoyo matambudziko muchirwere cheitsvo chisingaperi chinosanganiswa nerudzi rwe2 chirwere cheshuga
27 Rylaze asparaginase erwinia chrysanthemi (recombinant) -rywn 6/30/2021 Kurapa acute lymphoblastic leukemia uye lymphoblastic lymphoma muvarwere vasingawirirani neE. coli-derived asparaginase products, sechikamu chechirongwa chechemotherapy.
Press Release
26 Aduhelm aducanumab-avwa 6/7/2021 Kurapa chirwere cheAlzheimer
Press Release
25 Brexafemme ibrexafungerp 6/1/2021 Kurapa vulvovaginal candidiasis
24 Lybalvi olanzapine uye samidorphan 5/28/2021 Kurapa schizophrenia uye zvimwe zvikamu zvebipolar I disorder
23 Truseltiq infigratinib 5/28/2021 Kurapa cholangiocarcinoma ane chirwere chinosangana nemamwe maitiro
22 Lumakras sotorasib 5/28/2021 Kurapa marudzi egomarara remapapu asiri diki
Press Release
21 Pylarify piflufolastat F18 5/26/2021 Kuziva prostate-specific membrane antigen-positive maronda mugomarara reprostate
20 Rybrevant amivantamab-vmjw 5/21/2021 Kurapa chikamu chegomarara remapapu risiri diki
Press Release
19 Empaveli pegcetacoplan 5/14/2021 Kurapa paroxysmal nocturnal hemoglobinuria
18 Zynlonta loncastuximab tesirine-lpyl 4/23/2021 Kurapa mamwe marudzi ekudzokororwa kana refractory hombe B-cell lymphoma
17 Jemperli dostarlimab-gxly 4/22/2021 Kurapa endometrial cancer
Press Release
16 Nextstelles Estetrol uye drospirenone 4/15/2021 Kudzivirira kubata pamuviri
15 Qelbree viloxazine 4/2/2021 Kurapa kutarisisa kutadza hyperactivity disorder
14 Zegalogue dasiglucagon 3/22/2021 Kurapa yakanyanya hypoglycemia
13 Ponvory ponesimod 3/18/2021 Kurapa mafomu ekudzokazve kwemultiple sclerosis
12 Fotivda tivozanib 3/10/2021 Kurapa renal cell carcinoma
11 Azstarys serdexmethylphenidate uye 3/2/2021 Kurapa kutarisisa kutadza hyperactivity disorder
dexmethylphenidate
10 Pepaxto melphalan flufenamide 2/26/2021 Kurapa kudzokazve kana kuti refractory multiple myeloma
9 Nulibry fosdenopteri 2/26/2021 Kudzikisa njodzi yekufa mu molybdenum cofactor kushomeka Type A
Press Release
8 Amondys 45 casimersen 2/25/2021 Kurapa Duchenne muscular dystrophy
Press Release
7 Cosela trilacicilib 2/12/2021 Kudzikamisa chemotherapy-induced myelosuppression mudiki kenza yemapapu
Press Release
6 Evkeeza evinacumab-dgnb 2/11/2021 Kurapa homozygous mhuri hypercholesterolemia
5 Ukoniq umbralisib 2/5/2021 Kurapa marginal zone lymphoma uye follicular lymphoma
4 Tepmetko tepotinib 2/3/2021 Kurapa gomarara remapapu risiri diki
3 Lupkynis voclosporin 1/22/2021 Kurapa lupus nephritis
Drug Trials Snapshot
2 Cabenuva cabotegravir uye rilpivirine (yakabatanidzwa) 1/21/2021 Kurapa HIV
Press Release
Drug Trials Snapshot
1 Verquvo vericiguat 1/19/2021 Kudzikamisa njodzi yekufa kwemoyo uye kuchipatara nekuda kwekusagadzikana kwemoyo
Drug Trials Snapshot

 

Iyo yakanyorwa "FDA-yakatenderwa kushandiswa" pane ino webhusaiti ndeyezvinangwa zvekuratidzira chete.Kuona iyo FDA-yakatenderwa mamiriro ekushandiswa [semuenzaniso, chiratidzo(s), vanhu, dosing regimen(s)] kune chimwe nechimwe chezvigadzirwa izvi, ona ichangoburwa FDA-yakatenderwa Kunyora Ruzivo.
Dzvanya kubva kune FDA webhusaiti:https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2021


Nguva yekutumira: Sep-27-2021