Press Releases

Trevi Therapeutics, Inc. a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced that it has completed enrollment in its Phase 2b CORAL trial of Haduvio for the treatment of chronic cough in patients with IPF. Topline results continue to be expected in the first half of 2025. "Th

Eli Lilly and Company today announced at a press conference in Washington, D.C., plans to bolster its domestic medicine production across therapeutic areas by building four new pharmaceutical manufacturing sites in the United States. This brings the company's total U.S. capital expansion commitments to more than $50 billion since 2020. Three of the future U.S. sites announced today will focus on manufacturing active pharmaceutical ingredients (API), reshoring critical capabiliti

Biocon Limited, an innovation-led global biopharmaceutical company, today announced the launch of its GLP-1 peptide, Liraglutide, for diabetes and obesity, in the United Kingdom (U.K.). The drug-device combination will be marketed in the U.K. under the brand names Liraglutide Biocon for diabetes (gVictoza®) and Biolide for chronic weight management (gSaxenda®).  The launch follows the approval from the Medicines and Healthcare Products Regulatory Agency (MHRA), U.K., ea

Adcendo, a biotech company pioneering the development of first and best-in-class ADCs for cancers with a high unmet medical need, today announced that the U.S. Food & Drug Administration (FDA) has provided clearance of the IND application for a Phase I study evaluating ADCE-T02 in patients with advanced solid tumors. Tiffany-01 is an ongoing first-in-human Phase I multicenter, open-label, dose escalation study of ADCE-T02 as a monotherapy in patients with advanced solid tumors.

Telix Pharmaceuticals Limited today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for its breakthrough investigational kidney cancer PET[1] imaging agent TLX250-CDx  (Zircaix®[2], 89Zr-DFO-girentuximab), granted a Priority Review and provided a PDUFA[3] date of 27 August 2025, paving the way for a U.S. commercial launch in 2025. If approved, TLX250-CDx will become the first commercially availa

Nektar Therapeutics and TrialNet, an international clinical trial network at the forefront of diabetes research, today announced a new collaboration agreement to evaluate Nektar's rezpegaldesleukin in patients with new onset stage 3 type 1 diabetes mellitus (T1D). Rezpegaldesleukin is a novel agonistic T regulatory (Treg) cell biologic that is designed to both dampen the inflammatory response and simultaneously restore immune balance by directly expanding functional Treg cells and engagin

Innovent Biologics, Inc. a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that the New Drug Application (NDA) for ipilimumab injection (anti-CTLA-4 monoclonal antibody; R&D Code: IBI310) has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) a

Sterotherapeutics, a leading biopharmaceutical company dedicated to advancing innovative therapies, is announcing the launch of a Phase 2 clinical trial for ST-002, a novel drug candidate for patients with Cushing's Syndrome, a rare endocrine disorder with very limited available therapeutic options. An Investigators Meeting to start this study is scheduled for Monday, 24 February 2025, in Athens, Greece, when clinical investigators, research coordinators, and stakeholders will discuss tri

Charlotte's Web Holdings, Inc.  a market leader in hemp extract wellness products, is pleased to announce that the U.S. Food and Drug Administration (FDA) has completed its review of Phase 1 data and Investigational New Drug (IND) application submitted by DeFloria, Inc. ("DeFloria"). The FDA has concluded that DeFloria may now proceed with its planned FDA Phase 2 clinical trial for its botanical pharmaceutical candidate, AJA001 Oral Solution, a treatment for symptoms of aut

Harbour BioMed, a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on immunology and oncology, and Insilico Medicine ("Insilico"), a clinical stage generative artificial intelligence (AI)-driven biotechnology company, today announced a strategic collaboration to accelerate the discovery and development of innovative therapeutic antibodies, leveraging their respective technological strengths in anti