Industry News Drugs.com – New Drug Approvals FDA Approves Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq) Twice-A-Year Subcutaneous Injection for People With Relapsing and Progressive Multiple SclerosisSeptember 17, 2024 Tremfya (guselkumab) Receives U.S. FDA Approval for Adults with Moderately to Severely Active Ulcerative ColitisSeptember 13, 2024 FDA Approves Ebglyss (lebrikizumab-lbkz) for the Treatment of Atopic DermatitisSeptember 13, 2024 FDA Approves Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) Subcutaneous Anti-PD-(L)1 Cancer ImmunotherapySeptember 12, 2024 Travere Therapeutics Announces Full FDA Approval of Filspari (sparsentan), the Only Non-Immunosuppressive Treatment that Significantly Slows Kidney Function Decline in IgA NephropathySeptember 5, 2024 Emergent BioSolutions’ ACAM2000 (Smallpox and Mpox (Vaccinia) Vaccine, Live) Receives U.S. FDA Approval for Mpox IndicationAugust 29, 2024 FDA Approves Pavblu (aflibercept-ayyh), a Biosimilar to EyleaAugust 23, 2024 Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccine Targeting KP.2 Variant of SARS-CoV-2August 22, 2024 Pfizer and BioNTech Receive U.S. FDA Approval & Authorization for Omicron KP.2-adapted COVID-19 VaccineAugust 22, 2024 FDA Approves Rybrevant (amivantamab-vmjw) Plus Lazcluze (lazertinib) for Patients with EGFR-Mutated Advanced Lung cancerAugust 20, 2024 Drugs.com – New Drug Applications KalVista Announces FDA Acceptance of New Drug Application for Sebetralstat for Oral On-Demand Treatment of Hereditary AngioedemaSeptember 3, 2024 Unicycive Therapeutics Announces Submission of the New Drug Application (NDA) to the U.S. FDA for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on DialysisSeptember 3, 2024 Johnson & Johnson Seeks First Approval of Nipocalimab to Treat Broadest Population Living with Antibody Positive Generalized Myasthenia GravisAugust 29, 2024 Telix Submits NDA for TLX101-CDx (Pixclara) Brain Cancer Imaging AgentAugust 28, 2024 FDA Grants Priority Review to SpringWorks Therapeutics’ New Drug Application for Mirdametinib for the Treatment of Adults and Children with NF1-PNAugust 28, 2024 Soleno Therapeutics Announces U.S. FDA Acceptance for Filing and Priority Review of NDA for DCCR (Diazoxide Choline) Extended-Release Tablets in Prader-Willi SyndromeAugust 27, 2024 Regeneron Provides Update on Biologics License Application for LinvoseltamabAugust 20, 2024 U.S. FDA Grants Tentative Approval of Yutrepia (treprostinil) Inhalation Powder for Patients with Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)August 19, 2024 U.S. Food and Drug Administration Accepts for Priority Review Deciphera’s New Drug Application for Vimseltinib for the Treatment of Patients with Tenosynovial Giant Cell Tumor (TGCT)August 16, 2024 LENZ Therapeutics Announces Submission of New Drug Application to U.S. Food and Drug Administration for LNZ100 for the Treatment of PresbyopiaAugust 12, 2024 Drugs.com – Clinical Trials News Insilico Medicine Reports Positive Phase IIa Results for ISM001-055, a Novel First-in-Class Drug Treatment for Idiopathic Pulmonary Fibrosis (IPF) Designed Using Generative AISeptember 19, 2024 Ascletis Enters the Obesity Drug Space with Announcement of Two Ongoing U.S. Phase I Clinical Trials Utilizing Its Small Molecule GLP-1R Agonist ASC30September 17, 2024 Trishula Therapeutics Presents Positive Results from Phase 1 Trial of TTX-030 in First-Line Metastatic Pancreatic Cancer PatientsSeptember 16, 2024 Vico Therapeutics Announces Positive Interim Phase 1/2a Clinical Data of VO659 in Treatment of Huntington's DiseaseSeptember 14, 2024 Neurocrine Biosciences Provides Update on ERUDITE Phase 2 Data for Luvadaxistat in Adults with Cognitive Impairment Associated with SchizophreniaSeptember 13, 2024 Biolexis Unveils Promising Data with an Oral Weight Loss Drug: BLX-7006 Shows Significant Results in Preclinical StudiesSeptember 12, 2024 Dupixent Phase 3 Trial Confirms Significant Improvements in Itch and Hives for Patients with Chronic Spontaneous UrticariaSeptember 11, 2024 Once-weekly dose of insulin efsitora alfa delivers A1C reduction consistent with the most advanced daily insulin in people with type 2 diabetesSeptember 10, 2024 First Patients Treated in Phase 2 Clinical Trial of STAT3 Inhibitor in Combination with Radiation for the Treatment of GlioblastomaSeptember 9, 2024 Datopotamab Deruxtecan Showed Median Overall Survival of 14.6 Months in Patients with Advanced Nonsquamous Non-Small Cell Lung Cancer in TROPION-Lung01 Phase III TrialSeptember 9, 2024
