https://www.drugs.com/newdrugs.html New drug approvals news from Drugs.com. Comprehensive, up-to-date drug news for consumers and healthcare professionals. Thu, 18 Jun 2026 07:34:36 +0000 Thu, 18 Jun 2026 07:34:36 +0000 en-us https://www.drugs.com/newdrugs/fda-approves-utebzi-tebipenem-pivoxil-adults-complicated-urinary-tract-infections-6815.html GSK plc (LSE/NYSE: GSK) and Spero Therapeutics (Nasdaq: SPRO) today announced that the US Food and Drug Administration (FDA) has approved Utebzi, an oral antibiotic for the treatment of complicated urinary tract infections (cUTIs) including... Wed, 17 Jun 2026 04:06:46 +0000 https://www.drugs.com/newdrugs/sanofi-s-tzield-approved-us-first-modifying-therapy-patients-recently-diagnosed-stage-3-type-1-6811.html Paris, June 13, 2026. The US Food and Drug Administration (FDA) has granted accelerated approval to Tzield (teplizumab-mzwv) to delay the decline in endogenous (own) insulin production in children aged eight to 17 years recently diagnosed with... Sat, 13 Jun 2026 19:06:41 +0000 https://www.drugs.com/newdrugs/fda-approves-lilly-s-ebglyss-lebrikizumab-lbkz-one-maintenance-every-eight-weeks-patients-moderate-6809.html INDIANAPOLIS, June 9, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) approved a regimen of one maintenance dose every eight weeks of a single injection (250 mg/2 mL) of Ebglyss... Tue, 09 Jun 2026 01:06:03 +0000 https://www.drugs.com/newdrugs/u-s-fda-approves-pfizer-s-hympavzi-two-additional-hemophilia-b-patient-populations-significant-6808.html NEW YORK--(BUSINESS WIRE) June 08, 2026 -- Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Hympavzi (marstacimab-hncq) to include the treatment of patients with... Mon, 08 Jun 2026 23:06:47 +0000 https://www.drugs.com/newdrugs/fda-approves-xocova-ensitrelvir-first-only-oral-option-help-prevent-covid-19-following-exposure-6801.html OSAKA, Japan, June 1, 2026 – Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, PhD; hereinafter “Shionogi”) announced that the U.S. Food and Drug Administration (FDA) has approved Xocova... Mon, 01 Jun 2026 22:06:21 +0000 https://www.drugs.com/newdrugs/fda-approves-zaynich-cefepime-zidebactam-complicated-urinary-tract-infections-6802.html MUMBAI & SHORT HILLS, NEW JERSEY May 30, 2026 – Wockhardt today announced that the U.S. Food and Drug Administration (FDA) has approved Zaynich (cefepime and zidebactam), a novel intravenous antibiotic for the treatment of adults with... Sat, 30 May 2026 23:05:16 +0000 https://www.drugs.com/newdrugs/mannkind-announces-fda-approval-afrezza-first-only-inhaled-mealtime-insulin-children-adolescents-6800.html DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 29, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for... Fri, 29 May 2026 21:05:56 +0000 https://www.drugs.com/newdrugs/imfinzi-approved-us-first-only-immunotherapy-combination-patients-bcg-na-ve-risk-non-muscle-6799.html May 28, 2026 -- AstraZeneca’s Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy has been approved in the US for the treatment of adult patients with BCG-naïve, high-risk... Thu, 28 May 2026 21:05:48 +0000 https://www.drugs.com/newdrugs/fda-approves-label-expansion-cementing-tremfya-only-il-23-inhibitor-proven-help-stop-further-joint-6803.html HORSHAM, PA – (May 28, 2026) – Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to include evidence in the Tremfya... Thu, 28 May 2026 03:05:14 +0000 https://www.drugs.com/newdrugs/fda-approves-linzess-linaclotide-pediatric-patients-two-years-age-older-functional-constipation-fc-6798.html BOSTON--(BUSINESS WIRE) May 27, 2026 -- Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a biotechnology company developing and commercializing life changing therapies for people living with gastrointestinal (GI) and rare diseases, today announced... Wed, 27 May 2026 20:05:37 +0000 https://www.drugs.com/newdrugs/fda-approves-decnupaz-pivekimab-sunirine-pvzy-blastic-plasmacytoid-dendritic-cell-neoplasm-6797.html NORTH CHICAGO, Ill., May 27, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved Decnupaz (pivekimab sunirine-pvzy) for the treatment of adult patients with BPDCN, an ultra-rare and... Wed, 27 May 2026 19:05:26 +0000 https://www.drugs.com/newdrugs/fda-grants-accelerated-approval-hepcludex-bulevirtide-gmod-chronic-hepatitis-delta-virus-hdv-6795.html FOSTER CITY, Calif.--(BUSINESS WIRE) May 22, 2026 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Hepcludex (bulevirtide-gmod) 8.5 mg for the treatment... Fri, 22 May 2026 21:05:15 +0000 https://www.drugs.com/newdrugs/fda-approves-differin-epiduo-acne-gel-adapalene-benzoyl-peroxide-nonprescription-acne-6794.html Zug, Switzerland – May 22, 2026 – Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Differin Epiduo Acne Gel (Adapalene 0.1% and... Fri, 22 May 2026 20:05:30 +0000 https://www.drugs.com/newdrugs/datroway-approved-u-s-first-trop2-directed-antibody-conjugate-first-line-patients-metastatic-triple-6796.html Tokyo – (May 22, 2026) – Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/NYSE: AZN) Datroway® (datopotamab deruxtecan-dlnk) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic... Fri, 22 May 2026 01:05:54 +0000 https://www.drugs.com/newdrugs/fda-approves-baxfendy-baxdrostat-first-aldosterone-synthase-inhibitor-adults-hypertension-6790.html May 18, 2026 -- AstraZeneca’s Baxfendy (baxdrostat) has been approved in the US as a first-in-class aldosterone synthase inhibitor (ASI) for the treatment of hypertension in combination with other antihypertensive medications, to lower blood... Mon, 18 May 2026 22:05:07 +0000 https://www.drugs.com/newdrugs/fda-approves-trimbow-beclomethasone-formoterol-glycopyrrolate-inhaler-maintenance-asthma-6793.html Cary, N.C., May 18, 2026—Chiesi USA, Inc. (key-A-zee), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration has approved Trimbow (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate; or... Mon, 18 May 2026 06:05:09 +0000 https://www.drugs.com/newdrugs/fda-approves-immgolis-intri-golimumab-sldi-interchangeable-biosimilar-simponi-aria-golimumab-6791.html RALEIGH, N.C., May 18, 2026 /PRNewswire/ — Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. ("Intas Pharmaceuticals"), focused on the development of oncology, immunology and central nervous system (CNS)... Mon, 18 May 2026 02:05:59 +0000 https://www.drugs.com/newdrugs/fda-approves-immgolis-golimumab-sldi-interchangeable-biosimilar-simponi-6787.html RALEIGH, N.C., May 18, 2026 /PRNewswire/ — Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. ("Intas Pharmaceuticals"), focused on the development of oncology, immunology and central nervous system (CNS)... Mon, 18 May 2026 02:05:27 +0000 https://www.drugs.com/newdrugs/fda-approves-genentech-s-tecentriq-adjuvant-muscle-invasive-bladder-cancer-ctdna-guided-6788.html South San Francisco, CA -- May 15, 2026 -- Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza&reg... Fri, 15 May 2026 22:05:56 +0000 https://www.drugs.com/newdrugs/enhertu-approved-us-two-new-indications-patients-her2-positive-early-breast-cancer-6789.html Tokyo – (May 15, 2026) – Enhertu (fam-trastuzumab deruxtecan-nxki) has been approved by the U.S. Food and Drug Administration (FDA) for two new breast cancer indications in the neoadjuvant and adjuvant settings of patients with HER2... Fri, 15 May 2026 22:05:33 +0000 https://www.drugs.com/newdrugs/fasenra-approved-us-hypereosinophilic-syndrome-6792.html 14 May 2026 -- AstraZeneca’s Fasenra (benralizumab) has been approved by the US FDA for the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic... Thu, 14 May 2026 05:05:18 +0000 https://www.drugs.com/newdrugs/fda-approves-new-dosing-option-crysvita-burosumab-twza-adults-xlh-6786.html Princeton, N.J., May 14, 2026 – Kyowa Kirin, Inc., a wholly owned subsidiary of Kyowa Kirin Co. Ltd., today announced the U.S. Food and Drug Administration (FDA) has approved a dosing update to the Crysvita (burosumab-twza) Prescribing... Thu, 14 May 2026 00:05:35 +0000 https://www.drugs.com/newdrugs/fda-grants-accelerated-approval-beqalzi-sonrotoclax-relapsed-refractory-mantle-cell-lymphoma-6784.html SAN CARLOS, Calif.--(BUSINESS WIRE) May 13, 2026 -- BeOne Medicines Ltd. (“BeOne”) (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted... Wed, 13 May 2026 21:05:22 +0000 https://www.drugs.com/newdrugs/fda-approves-inqovi-combination-venetoclax-first-all-oral-combination-patients-acute-myeloid-6785.html PRINCETON, N.J. and TOKYO — May 13, 2026 -- Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd., today announced that the U.S. Food and Drug Administration (FDA) has approved Inqovi (decitabine and cedazuridine) plus venetoclax as a... Wed, 13 May 2026 21:05:20 +0000 https://www.drugs.com/newdrugs/argenx-announces-u-s-fda-approval-expanding-vyvgart-vyvgart-hytrulo-all-adult-patients-living-gmg-6782.html Amsterdam, the Netherlands – May 8, 2026 - argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced the U.S. Food and Drug... Fri, 08 May 2026 22:05:30 +0000 https://www.drugs.com/newdrugs/fda-approves-ocrevus-relapsing-remitting-multiple-sclerosis-pediatric-patients-10-years-age-older-6783.html South San Francisco, CA - May 8th, 2026 - Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), has received U.S. Food and Drug Administration (FDA) approval of Ocrevus (ocrelizumab) intravenous (IV) infusion for the treatment of... Fri, 08 May 2026 22:05:05 +0000 https://www.drugs.com/newdrugs/fda-approves-ennumo-pegfilgrastim-pccg-biosimilar-neulasta-6805.html May 7, 2026 -- The U.S. Food and Drug Administration (FDA) has approved Ennumo (pegfilgrastim-pccg), a biosimilar to Neulasta (pegfilgrastim). Ennumo is a leukocyte growth factor indicated to: Decrease the incidence of infection, as manifested... Thu, 07 May 2026 20:05:59 +0000 https://www.drugs.com/newdrugs/partner-therapeutics-announces-receipt-fda-commissioner-s-national-priority-voucher-bizengri-6781.html LEXINGTON, Mass. – May 06, 2026 – Partner Therapeutics, Inc. (PTx), a private, fully integrated biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has awarded a Commissioner’s National Priority... Wed, 06 May 2026 21:05:01 +0000 https://www.drugs.com/newdrugs/incyte-announces-fda-approval-jakafi-xr-ruxolitinib-extended-release-myelofibrosis-polycythemia-6777.html WILMINGTON, Del.--(BUSINESS WIRE)--May 1, 2026-- Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi XR™ (ruxolitinib) extended-release tablets for the treatment of adults with... Fri, 01 May 2026 02:05:55 +0000 https://www.drugs.com/newdrugs/fda-approves-veppanu-vepdegestrant-esr1m-er-her2-advanced-breast-cancer-6776.html NEW HAVEN, Conn., May 01, 2026 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today with its partner Pfizer Inc. (NYSE: PFE), announced that the U.S. Food and Drug Administration (FDA) has granted approval for Veppanu (vepdegestrant) for the... Fri, 01 May 2026 02:05:04 +0000 https://www.drugs.com/newdrugs/adma-biologics-announces-fda-approval-expand-label-asceniv-include-pediatric-immune-compromised-6780.html RAMSEY, N.J. and BOCA RATON, Fla., May 04, 2026 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), a U.S. based, end-to-end commercial biopharmaceutical company dedicated to manufacturing... Thu, 30 Apr 2026 21:05:52 +0000 https://www.drugs.com/newdrugs/axsome-therapeutics-announces-fda-approval-auvelity-dextromethorphan-hbr-bupropion-hcl-agitation-6775.html NEW YORK, April 30, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug... Thu, 30 Apr 2026 21:04:10 +0000 https://www.drugs.com/newdrugs/fda-approves-langlara-insulin-glargine-aldy-interchangeable-biosimilar-lantus-6779.html PHILADELPHIA - May 4, 2026 - Lannett Company, Inc., Lanexa Biologics, a wholly owned subsidiary of Lannett, and Sunshine Lake Pharma today announced that the U.S. Food and Drug Administration (FDA) has approved Langlara (insulin glargine-aldy), as a... Wed, 29 Apr 2026 21:05:16 +0000 https://www.drugs.com/newdrugs/breztri-approved-us-asthma-first-only-triple-therapy-patients-12-years-age-older-6773.html April 28, 2026 -- AstraZeneca’s fixed-dose triple-combination therapy Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate or BGF 320/36/9.6μg) has been approved in the US for the maintenance treatment of asthma in adult... Tue, 28 Apr 2026 20:04:56 +0000 https://www.drugs.com/newdrugs/saphnelo-approved-us-subcutaneous-self-administration-new-autoinjector-systemic-lupus-erythematosus-6772.html 27 April 2026 -- AstraZeneca’s Saphnelo (anifrolumab) has been approved in the US for self-administration as a once-weekly autoinjector, the Saphnelo Pen, for the treatment of adult patients with systemic lupus erythematosus (SLE) on top... Mon, 27 Apr 2026 20:04:23 +0000 https://www.drugs.com/newdrugs/fda-approves-caplyta-lumateperone-snda-robust-new-data-supporting-reduced-risk-relapse-schizophrenia-6774.html TITUSVILLE, N.J. (APRIL 27, 2026) – Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) based on long-term data evaluating the safety and efficacy of... Mon, 27 Apr 2026 20:04:07 +0000 https://www.drugs.com/newdrugs/fda-grants-accelerated-approval-otarmeni-lunsotogene-parvec-cwha-gene-therapy-genetic-hearing-loss-6770.html TARRYTOWN, N.Y., April 23, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Otarmeni (lunsotogene parvec-cwha), the first... Thu, 23 Apr 2026 23:04:53 +0000 https://www.drugs.com/newdrugs/sanofi-s-tzield-approved-u-s-delay-onset-stage-3-type-1-diabetes-young-children-6768.html Paris, April 22, 2026. The US Food and Drug Administration (FDA) has approved the supplemental biologic license application for Tzield (teplizumab-mzwv), expanding the indication from eight years and older to as young as one year of age to delay the... Wed, 22 Apr 2026 23:04:40 +0000 https://www.drugs.com/newdrugs/sanofi-regeneron-s-dupixent-approved-u-s-first-biologic-medicine-young-children-uncontrolled-6769.html Paris and Tarrytown, NY, April 22, 2026. The US Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of children aged two to 11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1... Wed, 22 Apr 2026 23:04:33 +0000 https://www.drugs.com/newdrugs/fda-approves-idvynso-doravirine-islatravir-hiv-1-infection-adults-6767.html RAHWAY, N.J.--(BUSINESS WIRE) April 21, 2026 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved Idvynso, a new, two-drug single-tablet regimen of... Tue, 21 Apr 2026 20:04:44 +0000