Live FDA approvals and announcements. https://quantisnow.com/news/fda en-us Mon, 08 Jun 2026 06:53:01 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://quantisnow.com/insight/fda-approval-for-children39s-allegra-allergy-issued-to-chattem-sanofi-6590368 https://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://quantisnow.com/insight/fda-approval-for-children39s-allegra-hives-issued-to-chattem-sanofi-6590367 https://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://quantisnow.com/insight/fda-approval-for-hepzato-issued-to-delcath-systems-inc-6578811 https://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://quantisnow.com/insight/fda-approval-for-decnupaz-issued-to-abbvie-inc-6578324 https://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://quantisnow.com/insight/fda-approval-for-hepcludex-issued-to-gilead-sciences-inc-6571148 https://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://quantisnow.com/insight/fda-tentative-approval-for-palbociclib-issued-to-dr-reddys-laboratories-6569091 https://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://quantisnow.com/insight/fda-approval-for-biktarvy-issued-to-gilead-sciences-inc-6567537 https://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://quantisnow.com/insight/fda-approval-for-biktarvy-issued-to-gilead-sciences-inc-6566734 https://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://quantisnow.com/insight/fda-approval-for-xyzal-allergy-24hr-issued-to-chattem-sanofi-6566134 https://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://quantisnow.com/insight/fda-approval-for-wezlana-issued-to-amgen-inc-6552048 https://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://quantisnow.com/insight/fda-approval-for-wezlana-issued-to-amgen-inc-6552047 https://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://quantisnow.com/insight/fda-approval-for-wezlana-issued-to-amgen-inc-6551782 https://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://quantisnow.com/insight/fda-approval-for-wezlana-issued-to-amgen-inc-6551781 https://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://quantisnow.com/insight/fda-approval-for-bizengri-issued-to-merus-nv-6546319 https://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://quantisnow.com/insight/fda-approval-for-bizengri-issued-to-merus-nv-6545611 https://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://quantisnow.com/insight/fda-approval-for-nuplazid-issued-to-acadia-pharms-inc-6531441 https://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://quantisnow.com/insight/fda-approval-for-pavblu-issued-to-amgen-inc-6522424 https://quantisnow.com/insight/fda-approval-for-pavblu-issued-to-amgen-inc-6522424 Thu, 30 Apr 2026 10:18:02 GMT Submission status for ACADIA PHARMS INC's drug NUPLAZID (SUPPL-16) with active ingredient PIMAVANSERIN TARTRATE has changed to 'Approval' on 04/27/2026. Application Category: NDA, Application Number: 207318, Application Classification: Efficacy https://quantisnow.com/insight/fda-approval-for-nuplazid-issued-to-acadia-pharms-inc-6519677 https://quantisnow.com/insight/fda-approval-for-nuplazid-issued-to-acadia-pharms-inc-6519677 Wed, 29 Apr 2026 08:49:48 GMT Submission status for ACADIA PHARMS INC's drug NUPLAZID (SUPPL-14) with active ingredient PIMAVANSERIN TARTRATE has changed to 'Approval' on 04/27/2026. Application Category: NDA, Application Number: 210793, Application Classification: Efficacy https://quantisnow.com/insight/fda-approval-for-nuplazid-issued-to-acadia-pharms-inc-6519676 https://quantisnow.com/insight/fda-approval-for-nuplazid-issued-to-acadia-pharms-inc-6519676 Wed, 29 Apr 2026 08:49:48 GMT Submission status for BIOGEN INC's drug ZURZUVAE (SUPPL-3) with active ingredient ZURANOLONE has changed to 'Approval' on 04/20/2026. Application Category: NDA, Application Number: 217369, Application Classification: Labeling https://quantisnow.com/insight/fda-approval-for-zurzuvae-issued-to-biogen-inc-6513255 https://quantisnow.com/insight/fda-approval-for-zurzuvae-issued-to-biogen-inc-6513255 Thu, 23 Apr 2026 22:14:48 GMT Submission status for PROVENTION BIO INC's drug TZIELD (SUPPL-13) with active ingredient TEPLIZUMAB-MZWV has changed to 'Approval' on 04/20/2026. Application Category: BLA, Application Number: 761183, Application Classification: https://quantisnow.com/insight/fda-approval-for-tzield-issued-to-provention-bio-inc-6513254 https://quantisnow.com/insight/fda-approval-for-tzield-issued-to-provention-bio-inc-6513254 Thu, 23 Apr 2026 22:14:48 GMT For Immediate Release: March 28, 2025 Today, the U.S. Food and Drug Administration approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or hemophilia B, with or without factor VIII or IX inhibitors (neutralizing antibodies).“Today’s approval of Qfitlia is significant for patients wi https://quantisnow.com/insight/march-28-2025---fda-approves-novel-treatment-for-hemophilia-5965569 https://quantisnow.com/insight/march-28-2025---fda-approves-novel-treatment-for-hemophilia-5965569 Sat, 29 Mar 2025 02:17:55 GMT For Immediate Release: March 11, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA published a General Correspondence Letter issued to Mid-Link Technology Testing Co., Ltd. The FDA is vigilant in ensuring data submitted to the FDA can be relied upon to assess the effectiveness, safety, or risk of a device. The FDA has noted an incr https://quantisnow.com/insight/march-11-2025---fda-roundup-march-11-2025-5942838 https://quantisnow.com/insight/march-11-2025---fda-roundup-march-11-2025-5942838 Thu, 13 Mar 2025 19:14:00 GMT For Immediate Release: February 28, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On Thursday, the FDA approved Odactra to include use in individuals 5 through 11 years of age to treat house dust mite induced nasal inflammation (allergic rhinitis), with or without eye inflammation (conjunctivitis). Odactra is an allergen extract immunotherapy https://quantisnow.com/insight/february-28-2025---fda-roundup-february-28-2025-5918005 https://quantisnow.com/insight/february-28-2025---fda-roundup-february-28-2025-5918005 Fri, 28 Feb 2025 22:00:47 GMT For Immediate Release: February 21, 2025 Today, the U.S. Food and Drug Administration approved Ctexli (chenodiol) for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. Ctexli is the first FDA-approved drug to treat CTX, a very rare lipid storage disease.“The FDA is dedicated to supporting new drug development for rare diseases including very rare metabolic diseases like cerebrotendinous xanthomato https://quantisnow.com/insight/february-21-2025---fda-approves-first-treatment-for-cerebrotendinous-5902358 https://quantisnow.com/insight/february-21-2025---fda-approves-first-treatment-for-cerebrotendinous-5902358 Fri, 21 Feb 2025 16:48:20 GMT For Immediate Release: February 14, 2025 Today, the U.S. Food and Drug Administration approved Merilog (insulin-aspart-szjj) as biosimilar to Novolog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. Merilog, a rapid-acting human insulin analog, is the first rapid-acting insulin biosimilar product approved by the FDA. As a rapid-acting insulin, Meri https://quantisnow.com/insight/february-14-2025---fda-approves-first-rapid-acting-insulin-biosimilar-5890131 https://quantisnow.com/insight/february-14-2025---fda-approves-first-rapid-acting-insulin-biosimilar-5890131 Fri, 14 Feb 2025 20:00:13 GMT For Immediate Release: January 30, 2025 Today, the U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. Journavx reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain.  Journavx is the first dr https://quantisnow.com/insight/january-30-2025---fda-approves-novel-non-opioid-treatment-for-5864039 https://quantisnow.com/insight/january-30-2025---fda-approves-novel-non-opioid-treatment-for-5864039 Thu, 30 Jan 2025 22:46:14 GMT For Immediate Release: December 13, 2024 Today, the U.S. Food and Drug Administration approved Crenessity (crinecerfont) to be used together with glucocorticoids (steroids) to control androgen (a testosterone-like hormone) levels in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH).“Today’s approval provides an important advance for patients with classic con https://quantisnow.com/insight/december-13-2024---fda-approves-new-treatment-for-congenital-5813572 https://quantisnow.com/insight/december-13-2024---fda-approves-new-treatment-for-congenital-5813572 Fri, 13 Dec 2024 22:54:17 GMT For Immediate Release: December 06, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On Thursday, the FDA published the draft guidance, “Expedited Program for Serious Conditions — Accelerated Approval of Drugs and Biologics,” which proposes updates to certain agency policies and procedures regarding accelerated approval. Topics addressed by this https://quantisnow.com/insight/december-6-2024---fda-roundup-december-6-2024-5803447 https://quantisnow.com/insight/december-6-2024---fda-roundup-december-6-2024-5803447 Fri, 06 Dec 2024 20:09:02 GMT Submission status for GILEAD SCIENCES INC's drug SUNLENCA (SUPPL-6) with active ingredient LENACAPAVIR SODIUM has changed to 'Approval' on 11/25/2024. Application Category: NDA, Application Number: 215973, Application Classification: Efficacy https://quantisnow.com/insight/fda-approval-for-sunlenca-issued-to-gilead-sciences-inc-5790986 https://quantisnow.com/insight/fda-approval-for-sunlenca-issued-to-gilead-sciences-inc-5790986 Tue, 26 Nov 2024 09:36:21 GMT Submission status for GILEAD SCIENCES INC's drug SUNLENCA (SUPPL-8) with active ingredient LENACAPAVIR SODIUM has changed to 'Approval' on 11/25/2024. Application Category: NDA, Application Number: 215974, Application Classification: Efficacy https://quantisnow.com/insight/fda-approval-for-sunlenca-issued-to-gilead-sciences-inc-5790985 https://quantisnow.com/insight/fda-approval-for-sunlenca-issued-to-gilead-sciences-inc-5790985 Tue, 26 Nov 2024 09:36:21 GMT Submission status for BRIDGEBIO PHARMA INC's drug ATTRUBY (ORIG-1) with active ingredient ACORAMIDIS has changed to 'Approval' on 11/22/2024. Application Category: NDA, Application Number: 216540, Application Classification: Type 1 - New Molecular Entity https://quantisnow.com/insight/fda-approval-for-attruby-issued-to-bridgebio-pharma-inc-5789680 https://quantisnow.com/insight/fda-approval-for-attruby-issued-to-bridgebio-pharma-inc-5789680 Mon, 25 Nov 2024 13:41:11 GMT Submission status for IMMUNOMEDICS INC's drug TRODELVY (SUPPL-58) with active ingredient SACITUZUMAB GOVITECAN-HZIY has changed to 'Approval' on 11/22/2024. Application Category: BLA, Application Number: 761115, Application Classification: https://quantisnow.com/insight/fda-approval-for-trodelvy-issued-to-immunomedics-inc-5789260 https://quantisnow.com/insight/fda-approval-for-trodelvy-issued-to-immunomedics-inc-5789260 Mon, 25 Nov 2024 09:48:58 GMT Submission status for HERON THERAPS INC's drug ZYNRELEF KIT (SUPPL-18) with active ingredient BUPIVACAINE; MELOXICAM has changed to 'Approval' on 11/21/2024. Application Category: NDA, Application Number: 211988, Application Classification: Labeling https://quantisnow.com/insight/fda-approval-for-zynrelef-kit-issued-to-heron-theraps-inc-5787576 https://quantisnow.com/insight/fda-approval-for-zynrelef-kit-issued-to-heron-theraps-inc-5787576 Fri, 22 Nov 2024 09:36:11 GMT Submission status for AMGEN INC's drug REPATHA (SUPPL-44) with active ingredient EVOLOCUMAB has changed to 'Approval' on 11/20/2024. Application Category: BLA, Application Number: 125522, Application Classification: https://quantisnow.com/insight/fda-approval-for-repatha-issued-to-amgen-inc-5786458 https://quantisnow.com/insight/fda-approval-for-repatha-issued-to-amgen-inc-5786458 Thu, 21 Nov 2024 17:43:07 GMT Submission status for SYNDAX PHARMACEUTICALS INC's drug REVUFORJ (ORIG-1) with active ingredient REVUMENIB has changed to 'Approval' on 11/15/2024. Application Category: NDA, Application Number: 218944, Application Classification: Type 1 - New Molecular Entity https://quantisnow.com/insight/fda-approval-for-revuforj-issued-to-syndax-pharmaceuticals-inc-5780230 https://quantisnow.com/insight/fda-approval-for-revuforj-issued-to-syndax-pharmaceuticals-inc-5780230 Mon, 18 Nov 2024 14:22:42 GMT Submission status for GILEAD SCIENCES INC's drug SUNLENCA (SUPPL-9) with active ingredient LENACAPAVIR SODIUM has changed to 'Approval' on 11/13/2024. Application Category: NDA, Application Number: 215973, Application Classification: Manufacturing (CMC) https://quantisnow.com/insight/fda-approval-for-sunlenca-issued-to-gilead-sciences-inc-5777922 https://quantisnow.com/insight/fda-approval-for-sunlenca-issued-to-gilead-sciences-inc-5777922 Fri, 15 Nov 2024 09:36:27 GMT Submission status for GILEAD SCIENCES INC's drug SUNLENCA (SUPPL-9) with active ingredient LENACAPAVIR SODIUM has changed to 'Approval' on 11/13/2024. Application Category: NDA, Application Number: 215974, Application Classification: Labeling https://quantisnow.com/insight/fda-approval-for-sunlenca-issued-to-gilead-sciences-inc-5774088 https://quantisnow.com/insight/fda-approval-for-sunlenca-issued-to-gilead-sciences-inc-5774088 Thu, 14 Nov 2024 16:31:57 GMT For Immediate Release: November 14, 2024 The U.S. Food and Drug Administration approved Kebilidi (eladocagene exuparvovec-tneq), an adeno-associated virus vector-based gene therapy indicated for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency. Kebilidi is the first FDA-approved gene therapy for treatment of AADC deficiency. “Clinical advancements in the f https://quantisnow.com/insight/november-14-2024---fda-approves-first-gene-therapy-for-5773555 https://quantisnow.com/insight/november-14-2024---fda-approves-first-gene-therapy-for-5773555 Thu, 14 Nov 2024 13:50:18 GMT Submission status for SANOFI-AVENTIS US's drug SOLIQUA 100/33 (SUPPL-14) with active ingredient INSULIN GLARGINE; LIXISENATIDE has changed to 'Approval' on 11/01/2024. Application Category: BLA, Application Number: 208673, Application Classification: https://quantisnow.com/insight/fda-approval-for-soliqua-10033-issued-to-sanofi-aventis-us-5748987 https://quantisnow.com/insight/fda-approval-for-soliqua-10033-issued-to-sanofi-aventis-us-5748987 Mon, 04 Nov 2024 09:49:34 GMT Submission status for SANOFI-AVENTIS US's drug ADLYXIN (SUPPL-9) with active ingredient LIXISENATIDE has changed to 'Approval' on 11/01/2024. Application Category: BLA, Application Number: 208471, Application Classification: https://quantisnow.com/insight/fda-approval-for-adlyxin-issued-to-sanofi-aventis-us-5748986 https://quantisnow.com/insight/fda-approval-for-adlyxin-issued-to-sanofi-aventis-us-5748986 Mon, 04 Nov 2024 09:49:34 GMT For Immediate Release: November 01, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA published the FDA Voices: “FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub,” by Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER) and Peter Marks, M.D., Ph.D., director https://quantisnow.com/insight/november-1-2024---fda-roundup-november-1-2024-5748106 https://quantisnow.com/insight/november-1-2024---fda-roundup-november-1-2024-5748106 Fri, 01 Nov 2024 19:18:19 GMT Submission status for TG THERAPEUTICS, INC's drug BRIUMVI (SUPPL-11) with active ingredient UBLITUXIMAB-XIIY has changed to 'Approval' on 10/30/2024. Application Category: BLA, Application Number: 761238, Application Classification: https://quantisnow.com/insight/fda-approval-for-briumvi-issued-to-tg-therapeutics-inc-5744792 https://quantisnow.com/insight/fda-approval-for-briumvi-issued-to-tg-therapeutics-inc-5744792 Thu, 31 Oct 2024 08:38:40 GMT For Immediate Release: October 29, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA responded to objections on the agency’s final rule that removed the authorized food contact uses of most phthalates because industry abandoned these uses. The FDA evaluated the objections and concluded that they did not provide a basis for mod https://quantisnow.com/insight/october-29-2024---fda-roundup-october-29-2024-5741499 https://quantisnow.com/insight/october-29-2024---fda-roundup-october-29-2024-5741499 Tue, 29 Oct 2024 19:30:19 GMT Submission status for SANOFI AVENTIS US's drug SARCLISA (SUPPL-12) with active ingredient ISATUXIMAB-IRFC has changed to 'Approval' on 10/25/2024. Application Category: BLA, Application Number: 761113, Application Classification: https://quantisnow.com/insight/fda-approval-for-sarclisa-issued-to-sanofi-aventis-us-5739105 https://quantisnow.com/insight/fda-approval-for-sarclisa-issued-to-sanofi-aventis-us-5739105 Mon, 28 Oct 2024 08:35:55 GMT Submission status for SANOFI AVENTIS US's drug SARCLISA (SUPPL-11) with active ingredient ISATUXIMAB-IRFC has changed to 'Approval' on 10/25/2024. Application Category: BLA, Application Number: 761113, Application Classification: https://quantisnow.com/insight/fda-approval-for-sarclisa-issued-to-sanofi-aventis-us-5739104 https://quantisnow.com/insight/fda-approval-for-sarclisa-issued-to-sanofi-aventis-us-5739104 Mon, 28 Oct 2024 08:35:55 GMT For Immediate Release: October 25, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA updated the advisory for the outbreak of E. coli O157:H7. A specific ingredient has not yet been confirmed as the source of the outbreak, but most sick people report eating McDonald’s Quarter Pounder burgers. Investigators are working to deter https://quantisnow.com/insight/october-25-2024---fda-roundup-october-25-2024-5738484 https://quantisnow.com/insight/october-25-2024---fda-roundup-october-25-2024-5738484 Fri, 25 Oct 2024 18:48:21 GMT Submission status for GILEAD SCIENCES INC's drug BIKTARVY (SUPPL-20) with active ingredient BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE has changed to 'Approval' on 10/08/2024. Application Category: NDA, Application Number: 210251, Application Classification: Manufacturing (CMC) https://quantisnow.com/insight/fda-approval-for-biktarvy-issued-to-gilead-sciences-inc-5733334 https://quantisnow.com/insight/fda-approval-for-biktarvy-issued-to-gilead-sciences-inc-5733334 Tue, 22 Oct 2024 20:04:28 GMT Submission status for ALVOTECH USA INC's drug SELARSDI (SUPPL-2) with active ingredient USTEKINUMAB-AEKN has changed to 'Approval' on 10/18/2024. Application Category: BLA, Application Number: 761343, Application Classification: https://quantisnow.com/insight/fda-approval-for-selarsdi-issued-to-alvotech-usa-inc-5732355 https://quantisnow.com/insight/fda-approval-for-selarsdi-issued-to-alvotech-usa-inc-5732355 Tue, 22 Oct 2024 02:44:05 GMT Submission status for ALVOTECH USA INC's drug SELARSDI (SUPPL-1) with active ingredient USTEKINUMAB-AEKN has changed to 'Approval' on 10/18/2024. Application Category: BLA, Application Number: 761343, Application Classification: https://quantisnow.com/insight/fda-approval-for-selarsdi-issued-to-alvotech-usa-inc-5731595 https://quantisnow.com/insight/fda-approval-for-selarsdi-issued-to-alvotech-usa-inc-5731595 Mon, 21 Oct 2024 18:59:28 GMT