Live FDA approvals and announcements. https://www.quantisnow.com/news/fda en-us Thu, 13 Aug 2026 06:02:59 GMT Submission status for LEXICON PHARMS INC's drug INPEFA (SUPPL-3) with active ingredient SOTAGLIFLOZIN has changed to 'Approval' on 08/06/2026. Application Category: NDA, Application Number: 216203, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-inpefa-issued-to-lexicon-pharms-inc-6672714 https://www.quantisnow.com/insight/fda-approval-for-inpefa-issued-to-lexicon-pharms-inc-6672714 Mon, 10 Aug 2026 11:40:05 GMT Submission status for GILEAD SCIENCES INC's drug VEKLURY (SUPPL-33) with active ingredient REMDESIVIR has changed to 'Approval' on 07/29/2026. Application Category: NDA, Application Number: 214787, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-veklury-issued-to-gilead-sciences-inc-6654544 https://www.quantisnow.com/insight/fda-approval-for-veklury-issued-to-gilead-sciences-inc-6654544 Thu, 30 Jul 2026 08:49:17 GMT Submission status for VANDA PHARMS INC's drug HETLIOZ (SUPPL-13) with active ingredient TASIMELTEON has changed to 'Approval' on 07/27/2026. Application Category: NDA, Application Number: 205677, Application Classification: Manufacturing (CMC) https://www.quantisnow.com/insight/fda-approval-for-hetlioz-issued-to-vanda-pharms-inc-6653201 https://www.quantisnow.com/insight/fda-approval-for-hetlioz-issued-to-vanda-pharms-inc-6653201 Wed, 29 Jul 2026 18:29:29 GMT Submission status for OUTLOOK THERAPEUTICS, INC.'s drug LYTENAVA (ORIG-1) with active ingredient BEVACIZUMAB-VIKG has changed to 'Approval' on 07/24/2026. Application Category: BLA, Application Number: 761320, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-lytenava-issued-to-outlook-therapeutics-inc-6649440 https://www.quantisnow.com/insight/fda-approval-for-lytenava-issued-to-outlook-therapeutics-inc-6649440 Mon, 27 Jul 2026 16:53:57 GMT Submission status for SANOFI AVENTIS US's drug AVAPRO (SUPPL-81) with active ingredient IRBESARTAN has changed to 'Approval' on 07/24/2026. Application Category: NDA, Application Number: 020757, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-avapro-issued-to-sanofi-aventis-us-6648789 https://www.quantisnow.com/insight/fda-approval-for-avapro-issued-to-sanofi-aventis-us-6648789 Mon, 27 Jul 2026 08:50:56 GMT Submission status for NUVALENT INC's drug JIDEYTRO (ORIG-1) with active ingredient ZIDESAMTINIB has changed to 'Approval' on 07/22/2026. Application Category: NDA, Application Number: 220185, Application Classification: Type 1 - New Molecular Entity https://www.quantisnow.com/insight/fda-approval-for-jideytro-issued-to-nuvalent-inc-6647816 https://www.quantisnow.com/insight/fda-approval-for-jideytro-issued-to-nuvalent-inc-6647816 Fri, 24 Jul 2026 10:38:55 GMT Submission status for LANNETT CO INC's drug METHADONE HYDROCHLORIDE (SUPPL-1) with active ingredient METHADONE HYDROCHLORIDE has changed to 'Approval' on 07/17/2026. Application Category: ANDA, Application Number: 212093, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-methadone-hydrochloride-issued-to-lannett-co-inc-6644361 https://www.quantisnow.com/insight/fda-approval-for-methadone-hydrochloride-issued-to-lannett-co-inc-6644361 Wed, 22 Jul 2026 08:48:32 GMT Submission status for LANNETT CO INC's drug METHADONE HYDROCHLORIDE (SUPPL-7) with active ingredient METHADONE HYDROCHLORIDE has changed to 'Approval' on 07/17/2026. Application Category: ANDA, Application Number: 212093, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-methadone-hydrochloride-issued-to-lannett-co-inc-6644360 https://www.quantisnow.com/insight/fda-approval-for-methadone-hydrochloride-issued-to-lannett-co-inc-6644360 Wed, 22 Jul 2026 08:48:32 GMT Submission status for LANNETT CO INC's drug METHADONE HYDROCHLORIDE (SUPPL-2) with active ingredient METHADONE HYDROCHLORIDE has changed to 'Approval' on 07/17/2026. Application Category: ANDA, Application Number: 212093, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-methadone-hydrochloride-issued-to-lannett-co-inc-6644359 https://www.quantisnow.com/insight/fda-approval-for-methadone-hydrochloride-issued-to-lannett-co-inc-6644359 Wed, 22 Jul 2026 08:48:32 GMT Submission status for LANNETT CO INC's drug METHADONE HYDROCHLORIDE (SUPPL-6) with active ingredient METHADONE HYDROCHLORIDE has changed to 'Approval' on 07/17/2026. Application Category: ANDA, Application Number: 212093, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-methadone-hydrochloride-issued-to-lannett-co-inc-6644358 https://www.quantisnow.com/insight/fda-approval-for-methadone-hydrochloride-issued-to-lannett-co-inc-6644358 Wed, 22 Jul 2026 08:48:32 GMT Submission status for CELCUITY INC..'s drug REVTORPYK (ORIG-1) with active ingredient GEDATOLISIB has changed to 'Approval' on 07/14/2026. Application Category: NDA, Application Number: 219908, Application Classification: Type 1 - New Molecular Entity https://www.quantisnow.com/insight/fda-approval-for-revtorpyk-issued-to-celcuity-inc-6638130 https://www.quantisnow.com/insight/fda-approval-for-revtorpyk-issued-to-celcuity-inc-6638130 Wed, 15 Jul 2026 19:03:57 GMT Submission status for AMGEN INC's drug REPATHA (SUPPL-49) with active ingredient EVOLOCUMAB has changed to 'Approval' on 07/15/2026. Application Category: BLA, Application Number: 125522, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-repatha-issued-to-amgen-inc-6637982 https://www.quantisnow.com/insight/fda-approval-for-repatha-issued-to-amgen-inc-6637982 Wed, 15 Jul 2026 14:42:34 GMT Submission status for SANOFI-AVENTIS U.S. LLC's drug SARCLISA ESCENA (ORIG-1) with active ingredient ISATUXIMAB-IRFC has changed to 'Approval' on 07/09/2026. Application Category: BLA, Application Number: 761445, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-sarclisa-escena-issued-to-sanofi-aventis-us-llc-6635207 https://www.quantisnow.com/insight/fda-approval-for-sarclisa-escena-issued-to-sanofi-aventis-us-llc-6635207 Mon, 13 Jul 2026 18:11:56 GMT Submission status for VERA THERAPEUTICS INC.'s drug TRUTAKNA (ORIG-1) with active ingredient ATACIEPT-VYMJ has changed to 'Approval' on 07/07/2026. Application Category: BLA, Application Number: 761486, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-trutakna-issued-to-vera-therapeutics-inc-6631394 https://www.quantisnow.com/insight/fda-approval-for-trutakna-issued-to-vera-therapeutics-inc-6631394 Wed, 08 Jul 2026 18:50:02 GMT Submission status for VIRIDIAN THERAPEUTICS INC's drug LUMVOA (ORIG-1) with active ingredient VELIGROTUG-VVZE has changed to 'Approval' on 06/26/2026. Application Category: BLA, Application Number: 761530, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-lumvoa-issued-to-viridian-therapeutics-inc-6620488 https://www.quantisnow.com/insight/fda-approval-for-lumvoa-issued-to-viridian-therapeutics-inc-6620488 Tue, 30 Jun 2026 16:20:03 GMT Submission status for INSMED INC's drug ARIKAYCE KIT (SUPPL-25) with active ingredient AMIKACIN SULFATE has changed to 'Approval' on 06/25/2026. Application Category: NDA, Application Number: 207356, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-arikayce-kit-issued-to-insmed-inc-6617987 https://www.quantisnow.com/insight/fda-approval-for-arikayce-kit-issued-to-insmed-inc-6617987 Mon, 29 Jun 2026 08:48:07 GMT Submission status for ABBVIE INC's drug SKYRIZI (SUPPL-16) with active ingredient RISANKIZUMAB-RZAA has changed to 'Approval' on 06/26/2026. Application Category: BLA, Application Number: 761262, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-skyrizi-issued-to-abbvie-inc-6617986 https://www.quantisnow.com/insight/fda-approval-for-skyrizi-issued-to-abbvie-inc-6617986 Mon, 29 Jun 2026 08:48:07 GMT Submission status for SANOFI AVENTIS US's drug SARCLISA (SUPPL-18) with active ingredient ISATUXIMAB-IRFC has changed to 'Approval' on 06/26/2026. Application Category: BLA, Application Number: 761113, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-sarclisa-issued-to-sanofi-aventis-us-6617985 https://www.quantisnow.com/insight/fda-approval-for-sarclisa-issued-to-sanofi-aventis-us-6617985 Mon, 29 Jun 2026 08:48:07 GMT Submission status for ABBVIE INC's drug SKYRIZI (SUPPL-45) with active ingredient RISANKIZUMAB-RZAA has changed to 'Approval' on 06/26/2026. Application Category: BLA, Application Number: 761105, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-skyrizi-issued-to-abbvie-inc-6617984 https://www.quantisnow.com/insight/fda-approval-for-skyrizi-issued-to-abbvie-inc-6617984 Mon, 29 Jun 2026 08:48:07 GMT Submission status for IMMUNOMEDICS INC's drug TRODELVY (SUPPL-63) with active ingredient SACITUZUMAB GOVITECAN-HZIY has changed to 'Approval' on 06/24/2026. Application Category: BLA, Application Number: 761115, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-trodelvy-issued-to-immunomedics-inc-6614914 https://www.quantisnow.com/insight/fda-approval-for-trodelvy-issued-to-immunomedics-inc-6614914 Thu, 25 Jun 2026 08:48:53 GMT Submission status for IONIS PHARMS INC's drug TRYNGOLZA (AUTOINJECTOR) (SUPPL-4) with active ingredient OLEZARSEN SODIUM has changed to 'Approval' on 06/24/2026. Application Category: NDA, Application Number: 218614, Application Classification: Efficacy https://www.quantisnow.com/insight/fda-approval-for-tryngolza-autoinjector-issued-to-ionis-pharms-inc-6614913 https://www.quantisnow.com/insight/fda-approval-for-tryngolza-autoinjector-issued-to-ionis-pharms-inc-6614913 Thu, 25 Jun 2026 08:48:53 GMT Submission status for IMMUNOMEDICS INC's drug TRODELVY (SUPPL-64) with active ingredient SACITUZUMAB GOVITECAN-HZIY has changed to 'Approval' on 06/24/2026. Application Category: BLA, Application Number: 761115, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-trodelvy-issued-to-immunomedics-inc-6614912 https://www.quantisnow.com/insight/fda-approval-for-trodelvy-issued-to-immunomedics-inc-6614912 Thu, 25 Jun 2026 08:48:53 GMT Submission status for LANNETT CO INC's drug HYDROCODONE BITARTRATE AND ACETAMINOPHEN (SUPPL-14) with active ingredient ACETAMINOPHEN; HYDROCODONE BITARTRATE has changed to 'Approval' on 06/18/2026. Application Category: ANDA, Application Number: 207172, Application Classification: REMS https://www.quantisnow.com/insight/fda-approval-for-hydrocodone-bitartrate-and-acetaminophen-issued-to-lannett-6609675 https://www.quantisnow.com/insight/fda-approval-for-hydrocodone-bitartrate-and-acetaminophen-issued-to-lannett-6609675 Fri, 19 Jun 2026 08:55:22 GMT Submission status for LANNETT CO INC's drug OXYCODONE AND ACETAMINOPHEN (SUPPL-18) with active ingredient ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE has changed to 'Approval' on 06/18/2026. Application Category: ANDA, Application Number: 207333, Application Classification: REMS https://www.quantisnow.com/insight/fda-approval-for-oxycodone-and-acetaminophen-issued-to-lannett-co-6609674 https://www.quantisnow.com/insight/fda-approval-for-oxycodone-and-acetaminophen-issued-to-lannett-co-6609674 Fri, 19 Jun 2026 08:55:26 GMT Submission status for LANNETT CO INC's drug HYDROCODONE BITARTRATE AND ACETAMINOPHEN (SUPPL-14) with active ingredient ACETAMINOPHEN; HYDROCODONE BITARTRATE has changed to 'Approval' on 06/18/2026. Application Category: ANDA, Application Number: 207171, Application Classification: REMS https://www.quantisnow.com/insight/fda-approval-for-hydrocodone-bitartrate-and-acetaminophen-issued-to-lannett-6609673 https://www.quantisnow.com/insight/fda-approval-for-hydrocodone-bitartrate-and-acetaminophen-issued-to-lannett-6609673 Fri, 19 Jun 2026 08:55:20 GMT Submission status for LANNETT CO INC's drug OXYCODONE HYDROCHLORIDE (SUPPL-16) with active ingredient OXYCODONE HYDROCHLORIDE has changed to 'Approval' on 06/18/2026. Application Category: ANDA, Application Number: 203823, Application Classification: REMS https://www.quantisnow.com/insight/fda-approval-for-oxycodone-hydrochloride-issued-to-lannett-co-inc-6609672 https://www.quantisnow.com/insight/fda-approval-for-oxycodone-hydrochloride-issued-to-lannett-co-inc-6609672 Fri, 19 Jun 2026 08:54:17 GMT Submission status for LANNETT CO INC's drug CODEINE SULFATE (SUPPL-21) with active ingredient CODEINE SULFATE has changed to 'Approval' on 06/18/2026. Application Category: ANDA, Application Number: 203046, Application Classification: REMS https://www.quantisnow.com/insight/fda-approval-for-codeine-sulfate-issued-to-lannett-co-inc-6609671 https://www.quantisnow.com/insight/fda-approval-for-codeine-sulfate-issued-to-lannett-co-inc-6609671 Fri, 19 Jun 2026 08:54:10 GMT Submission status for AMPHASTAR PHARMS INC's drug REXTOVY (SUPPL-2) with active ingredient NALOXONE HYDROCHLORIDE has changed to 'Approval' on 06/16/2026. Application Category: NDA, Application Number: 208969, Application Classification: Efficacy https://www.quantisnow.com/insight/fda-approval-for-rextovy-issued-to-amphastar-pharms-inc-6604038 https://www.quantisnow.com/insight/fda-approval-for-rextovy-issued-to-amphastar-pharms-inc-6604038 Tue, 16 Jun 2026 12:20:56 GMT Submission status for ABBVIE INC's drug SKYRIZI (SUPPL-44) with active ingredient RISANKIZUMAB-RZAA has changed to 'Approval' on 06/12/2026. Application Category: BLA, Application Number: 761105, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-skyrizi-issued-to-abbvie-inc-6603694 https://www.quantisnow.com/insight/fda-approval-for-skyrizi-issued-to-abbvie-inc-6603694 Tue, 16 Jun 2026 08:45:14 GMT Submission status for ABBVIE INC's drug SKYRIZI (SUPPL-15) with active ingredient RISANKIZUMAB-RZAA has changed to 'Approval' on 06/12/2026. Application Category: BLA, Application Number: 761262, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-skyrizi-issued-to-abbvie-inc-6603693 https://www.quantisnow.com/insight/fda-approval-for-skyrizi-issued-to-abbvie-inc-6603693 Tue, 16 Jun 2026 08:45:14 GMT Submission status for PROVENTION BIO INC's drug TZIELD (SUPPL-10) with active ingredient TEPLIZUMAB-MZWV has changed to 'Approval' on 06/12/2026. Application Category: BLA, Application Number: 761183, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-tzield-issued-to-provention-bio-inc-6602034 https://www.quantisnow.com/insight/fda-approval-for-tzield-issued-to-provention-bio-inc-6602034 Mon, 15 Jun 2026 12:33:18 GMT Submission status for PROVENTION BIO INC's drug TZIELD (SUPPL-14) with active ingredient TEPLIZUMAB-MZWV has changed to 'Approval' on 06/12/2026. Application Category: BLA, Application Number: 761183, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-tzield-issued-to-provention-bio-inc-6602033 https://www.quantisnow.com/insight/fda-approval-for-tzield-issued-to-provention-bio-inc-6602033 Mon, 15 Jun 2026 12:33:18 GMT Submission status for PFIZER INC's drug HYMPAVZI (SUPPL-3) with active ingredient MARSTACIMAB-HNCQ has changed to 'Approval' on 06/05/2026. Application Category: BLA, Application Number: 761369, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-hympavzi-issued-to-pfizer-inc-6594322 https://www.quantisnow.com/insight/fda-approval-for-hympavzi-issued-to-pfizer-inc-6594322 Tue, 09 Jun 2026 08:46:31 GMT Submission status for CHATTEM SANOFI's drug CHILDREN'S ALLEGRA ALLERGY (SUPPL-19) with active ingredient FEXOFENADINE HYDROCHLORIDE has changed to 'Approval' on 06/04/2026. Application Category: NDA, Application Number: 021909, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-children39s-allegra-allergy-issued-to-chattem-sanofi-6590368 https://www.quantisnow.com/insight/fda-approval-for-children39s-allegra-allergy-issued-to-chattem-sanofi-6590368 Fri, 05 Jun 2026 08:50:05 GMT Submission status for CHATTEM SANOFI's drug CHILDREN'S ALLEGRA HIVES (SUPPL-19) with active ingredient FEXOFENADINE HYDROCHLORIDE has changed to 'Approval' on 06/04/2026. Application Category: NDA, Application Number: 021909, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-children39s-allegra-hives-issued-to-chattem-sanofi-6590367 https://www.quantisnow.com/insight/fda-approval-for-children39s-allegra-hives-issued-to-chattem-sanofi-6590367 Fri, 05 Jun 2026 08:50:05 GMT Submission status for DELCATH SYSTEMS INC's drug HEPZATO (SUPPL-16) with active ingredient MELPHALAN HYDROCHLORIDE has changed to 'Approval' on 05/29/2026. Application Category: NDA, Application Number: 201848, Application Classification: REMS https://www.quantisnow.com/insight/fda-approval-for-hepzato-issued-to-delcath-systems-inc-6578811 https://www.quantisnow.com/insight/fda-approval-for-hepzato-issued-to-delcath-systems-inc-6578811 Fri, 29 May 2026 18:15:08 GMT Submission status for ABBVIE INC's drug DECNUPAZ (ORIG-1) with active ingredient PIVEKIMAB SUNIRINE-PVZY has changed to 'Approval' on 05/27/2026. Application Category: BLA, Application Number: 761460, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-decnupaz-issued-to-abbvie-inc-6578324 https://www.quantisnow.com/insight/fda-approval-for-decnupaz-issued-to-abbvie-inc-6578324 Fri, 29 May 2026 11:34:21 GMT Submission status for GILEAD SCIENCES INC's drug HEPCLUDEX (ORIG-1) with active ingredient BULEVIRTIDE-GMOD) has changed to 'Approval' on 05/22/2026. Application Category: BLA, Application Number: 761468, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-hepcludex-issued-to-gilead-sciences-inc-6571148 https://www.quantisnow.com/insight/fda-approval-for-hepcludex-issued-to-gilead-sciences-inc-6571148 Tue, 26 May 2026 10:57:56 GMT Submission status for DR. REDDY'S LABORATORIES LIMITED's drug PALBOCICLIB (ORIG-1) with active ingredient PALBOCICLIB has changed to 'Tentative Approval' on 05/15/2026. Application Category: ANDA, Application Number: 220444, Application Classification: https://www.quantisnow.com/insight/fda-tentative-approval-for-palbociclib-issued-to-dr-reddys-laboratories-6569091 https://www.quantisnow.com/insight/fda-tentative-approval-for-palbociclib-issued-to-dr-reddys-laboratories-6569091 Fri, 22 May 2026 13:41:25 GMT Submission status for GILEAD SCIENCES INC's drug BIKTARVY (SUPPL-26) with active ingredient BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE has changed to 'Approval' on 05/21/2026. Application Category: NDA, Application Number: 210251, Application Classification: Manufacturing (CMC) https://www.quantisnow.com/insight/fda-approval-for-biktarvy-issued-to-gilead-sciences-inc-6567537 https://www.quantisnow.com/insight/fda-approval-for-biktarvy-issued-to-gilead-sciences-inc-6567537 Thu, 21 May 2026 20:17:16 GMT Submission status for GILEAD SCIENCES INC's drug BIKTARVY (SUPPL-26) with active ingredient BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE has changed to 'Approval' on 05/21/2026. Application Category: NDA, Application Number: 210251, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-biktarvy-issued-to-gilead-sciences-inc-6566734 https://www.quantisnow.com/insight/fda-approval-for-biktarvy-issued-to-gilead-sciences-inc-6566734 Thu, 21 May 2026 13:34:58 GMT Submission status for CHATTEM SANOFI's drug XYZAL ALLERGY 24HR (SUPPL-10) with active ingredient LEVOCETIRIZINE DIHYDROCHLORIDE has changed to 'Approval' on 05/20/2026. Application Category: NDA, Application Number: 209089, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-xyzal-allergy-24hr-issued-to-chattem-sanofi-6566134 https://www.quantisnow.com/insight/fda-approval-for-xyzal-allergy-24hr-issued-to-chattem-sanofi-6566134 Thu, 21 May 2026 08:47:30 GMT Submission status for AMGEN INC's drug WEZLANA (SUPPL-6) with active ingredient USTEKINUMAB-AUUB has changed to 'Approval' on 05/12/2026. Application Category: BLA, Application Number: 761331, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-wezlana-issued-to-amgen-inc-6552048 https://www.quantisnow.com/insight/fda-approval-for-wezlana-issued-to-amgen-inc-6552048 Thu, 14 May 2026 08:46:48 GMT Submission status for AMGEN INC's drug WEZLANA (SUPPL-6) with active ingredient USTEKINUMAB-AUUB has changed to 'Approval' on 05/12/2026. Application Category: BLA, Application Number: 761285, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-wezlana-issued-to-amgen-inc-6552047 https://www.quantisnow.com/insight/fda-approval-for-wezlana-issued-to-amgen-inc-6552047 Thu, 14 May 2026 08:46:48 GMT Submission status for AMGEN INC's drug WEZLANA (SUPPL-6) with active ingredient USTEKINUMAB-AUUB has changed to 'Approval' on 05/13/2026. Application Category: BLA, Application Number: 761331, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-wezlana-issued-to-amgen-inc-6551782 https://www.quantisnow.com/insight/fda-approval-for-wezlana-issued-to-amgen-inc-6551782 Wed, 13 May 2026 21:52:02 GMT Submission status for AMGEN INC's drug WEZLANA (SUPPL-6) with active ingredient USTEKINUMAB-AUUB has changed to 'Approval' on 05/13/2026. Application Category: BLA, Application Number: 761285, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-wezlana-issued-to-amgen-inc-6551781 https://www.quantisnow.com/insight/fda-approval-for-wezlana-issued-to-amgen-inc-6551781 Wed, 13 May 2026 21:52:02 GMT Submission status for MERUS N.V.'s drug BIZENGRI (SUPPL-10) with active ingredient ZENOCUTUZUMAB-ZBCO has changed to 'Approval' on 05/08/2026. Application Category: BLA, Application Number: 761352, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-bizengri-issued-to-merus-nv-6546319 https://www.quantisnow.com/insight/fda-approval-for-bizengri-issued-to-merus-nv-6546319 Tue, 12 May 2026 08:49:25 GMT Submission status for MERUS N.V.'s drug BIZENGRI (SUPPL-10) with active ingredient ZENOCUTUZUMAB-ZBCO has changed to 'Approval' on 05/11/2026. Application Category: BLA, Application Number: 761352, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-bizengri-issued-to-merus-nv-6545611 https://www.quantisnow.com/insight/fda-approval-for-bizengri-issued-to-merus-nv-6545611 Mon, 11 May 2026 20:51:23 GMT Submission status for ACADIA PHARMS INC's drug NUPLAZID (SUPPL-16) with active ingredient PIMAVANSERIN TARTRATE has changed to 'Approval' on 05/04/2026. Application Category: NDA, Application Number: 210793, Application Classification: Labeling https://www.quantisnow.com/insight/fda-approval-for-nuplazid-issued-to-acadia-pharms-inc-6531441 https://www.quantisnow.com/insight/fda-approval-for-nuplazid-issued-to-acadia-pharms-inc-6531441 Tue, 05 May 2026 16:47:09 GMT Submission status for AMGEN INC's drug PAVBLU (SUPPL-5) with active ingredient AFLIBERCEPT-AYYH has changed to 'Approval' on 04/28/2026. Application Category: BLA, Application Number: 761298, Application Classification: https://www.quantisnow.com/insight/fda-approval-for-pavblu-issued-to-amgen-inc-6522424 https://www.quantisnow.com/insight/fda-approval-for-pavblu-issued-to-amgen-inc-6522424 Thu, 30 Apr 2026 10:18:02 GMT