Theravance Biopharma, Inc. announced completion of enrollment in the open-label portion of its pivotal Phase 3 CYPRESS study in patients with symptomatic neurogenic orthostatic hypotension (nOH) due to multiple system atrophy (MSA), a rare and...
PharmaJet®, a company that strives to improve the performance and outcomes of injectables with its enabling needle-free injection technology, announced that the WHO prequalified Tropis ID delivery system will be used to support a polio eradication...
Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Modeyso™ (dordaviprone) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma...
The Lung Cancer Research Foundation (LCRF) announces a new research collaboration with Boehringer Ingelheim creating two funding mechanisms designed to address HER2 mutations in lung cancer: a new Team Science Award and an Early Career...
Nuvation Bio Inc. a global oncology company focused on tackling some of the toughest challenges in cancer treatment, announced that the U.S. Food and Drug Administration (FDA) has approved IBTROZI™ (taletrectinib) for the treatment of adult...
Samsung Bioepis Co., Ltd. and Organon & Co. announced that the US Food and Drug Administration (FDA) has designated the HADLIMA™ (adalimumab-bwwd) high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration...
Rein Therapeutics a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, announced that the RENEW Phase 2 trial of its lead asset,...
Longhorn Vaccines and Diagnostics, a One Health company developing vaccines and diagnostic tools for global public health and zoonosis concerns, presented new data on LHNVD-303, the company's composite peptide vaccine for sepsis due to bacterial...
Creyon Bio, Inc. announced the appointment of industry leader, Serge Messerlian as Chief Executive Officer, effective immediately. Mr. Messerlian brings Creyon Bio a track record in both multinational pharmaceutical and biotechnology leadership as...
Beacon Therapeutics Holdings Limited a leading ophthalmic gene therapy company with a mission to save and restore the vision of patients with blinding retinal diseases, announced that the U.S. Food and Drug Administration (FDA) has granted...
Pilatus Biosciences Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its leading molecule, PLT012, for treating liver and intrahepatic bile duct cancer (HCC/ICCA). Achieved in November...
UroMems, a global medical technology company developing the first smart automated implant to treat stress urinary incontinence (SUI), today announced the appointment of medical device veteran Rinda Sama to its board of directors. "We are thrilled...
BioArctic AB's partner Eisai announced that the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has approved Leqembi (lecanemab) for the treatment of early Alzheimer's disease (AD)1. Leqembi selectively binds to...
SciTech Development, a clinical-stage pharmaceutical company focused on advancements in cancer treatment, is excited to share promising updates from its clinical trial of ST-001 nanoFenretinide (ST-001). Preliminary Trial Findings: Preliminary...
Aisa Pharma, Inc. a private, clinical-stage biopharmaceutical company announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to AISA-021(cilnidipine), a fourth-generation calcium channel antagonist. Aisa is...
Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi® (seladelpar) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in...
Citius Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved LYMPHIR™ (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of r/r cutaneous T-cell lymphoma (CTCL) after at least one prior...
Cytonics Corporation, a private biotechnology company developing biologic therapies for musculoskeletal ailments, announced initiation of enrollment for its Phase 1 clinical study of CYT-108. A recombinant variant of the alpha-2-macroglobulin...
CalciMedica Inc. a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses, announced positive topline...
Lykos Therapeutics ("Lykos"), a company dedicated to transforming mental healthcare, announced the outcome of the U.S. Food and Drug Administration's ("FDA") Psychopharmacologic Drugs Advisory Committee ("PDAC"), which discussed the Company's new...