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Application Number Application Type Drug Name Active Ingredients Dosage Form/Route Approval Date Company
761310 BLA ELAHERE MIRVETUXIMAB SORAVTANSINE-GYNX INJECTABLE;INJECTION 2022-11-14 IMMUNOGEN INC
761291 BLA TECVAYLI TECLISTAMAB-CQYV INJECTABLE;INJECTION 2022-10-25 JANSSEN BIOTECH
761289 BLA IMJUDO TREMELIMUMAB-ACTL INJECTABLE;INTRAVENOUS 2022-10-21 ASTRAZENECA AB
761270 BLA IMJUDO TREMELIMUMAB-ACTL INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 2022-11-10 ASTRAZENECA AB
761269 BLA LEQEMBI LECANEMAB-IRMB INJECTABLE;INJECTION 2023-01-06 EISAI INC
761268 BLA VEGZELMA BEVACIZUMAB-ADCD INJECTABLE;INJECTION 2022-09-27 CELLTRION
761263 BLA LUNSUMIO MOSUNETUZUMAB-AXGB INJECTABLE;INJECTION 2022-12-22 GENENTECH INC
761262 BLA SKYRIZI RISANKIZUMAB-RZAA INJECTABLE;INTRAVENOUS 2022-06-16 ABBVIE INC
761261 BLA XENPOZYME OLIPUDASE ALFA-RPCP INJECTABLE;INJECTION 2022-08-31 GENZYME CORP
761255 BLA IDACIO ADALIMUMAB-AACF INJECTABLE;SUBCUTANEOUS 2022-12-13 FRESENIUS KABI USA
761244 BLA SPEVIGO SPESOLIMAB-SBZO INJECTABLE;INTRAVENOUS 2022-09-01 BOEHRINGER INGELHEIM PHARMACEUTICALS INC
761238 BLA BRIUMVI UBLITUXIMAB-XIIY INJECTABLE;INTRAVENOUS 2022-12-28 TG THERAPEUTICS, INC
761235 BLA VABYSMO FARICIMAB-SVOA INJECTABLE; INTRAVITREAL 2022-01-28 GENENTECH INC
761234 BLA OPDUALAG NIVOLUMAB;RELATLIMAB-RMBW SOLUTION;INTRAVENOUS 2022-03-18 BRISTOL MYERS SQUIBB
761231 BLA ALYMSYS BEVACIZUMAB-MALY INJECTABLE;INJECTION 2022-04-13 AMNEAL PHARMS LLC
761228 BLA KIMMTRAK TEBENTAFUSP-TEBN INJECTABLE;INJECTION 2022-01-25 IMMUNOCORE LTD
761224 BLA TEZSPIRE TEZEPELUMAB-EKKO SOLUTION;SUBCUTANEOUS 2021-12-17 ASTRAZENECA AB
761223 BLA JEMPERLI DOSTARLIMAB-GXLY INJECTABLE;INJECTION 2021-08-17 GLAXOSMITHKLINE LLC
761216 BLA YUSIMRY ADALIMUMAB-AQVH INJECTABLE;INJECTION 2021-12-17 COHERUS BIOSCIENCES INC
761215 BLA REZVOGLAR INSULIN GLARGINE-AGLR INJECTABLE;INJECTION 2021-12-17 ELI LILLY CO