Press Releases

StemCyte Inc., a wholly owned subsidiary of StemCyte International Ltd., announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for its HPC, Cord Blood product REGENECYTE™, a vital cord blood stem cell therapy for transplantation in patients with blood and immune system disorders. With this approval, StemCyte became the 15th company to receive BLA approval in 2024 and the first commercial U.S. based biotech company to secure

GSK plc today announced the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for Blenrep (belantamab mafodotin) in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for the treatment of patients with multiple myeloma who have received at least one prior line of therapy. The US FDA has assigned a Prescription Drug User Fee Act action date of 23 July 2025. Hesham Abd

Sartorius Stedim Biotech, a leading partner of the biopharmaceutical industry, today opened its new Center for Bioprocess Innovation in Marlborough, Massachusetts. This state-of-the-art facility is designed to foster collaboration, co-development and learning on site with customers and other external innovation partners, applying Sartorius' latest technologies in real-life bioprocess workflows. "Cell and gene therapies and other novel treatments offer promising solutions fo

GSK plc today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved a regulatory application to extend the indication of Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) for the prevention of RSV disease to include adults aged 50-59 at increased risk. Since September 2023, GSK’s RSV vaccine has been approved in Japan for adults aged 60 and over for the prevention of RSV disease.2 Tony Wood, Chief Scientific Officer at

Laekna, Inc., a global biotech company focused on novel drug development for metabolic and cancer diseases, is pleased to announce a clinical collaboration with Eli Lilly and Company (Lilly), a global leader in cardiometabolic health, including diabetes and obesity, to accelerate the development of LAE102, a novel ActRIIA mAb as a novel treatment for obesity.  Accelerating innovative treatments like this hopefully can make a meaningful impact on the obesity epidemic and the lives of mill

The National Medical Products Administration (NMPA) announced on its official website that the NMPA approved the listing of Zorifertinib Hydrochloride Tablets (trade name: Zorifer®), a Class 1 innovative drug, developed by Alpha Biopharma. This product is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) accompanied with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mut

Abzena, the leading end-to-end integrated CDMO + CRO for complex biologics and bioconjugates, announced the expansion of their early and late- phase analytical capabilities to now include GMP cell-based potency assays at their Cambridge, UK and San Diego, CA development and manufacturing facilities. The expansion enhances Abzena’s extensive bioassay offering, providing customers with a more comprehensive, streamlined, and cost-effective way to access critical data faster. GMP

Samsung Biologics, a global contract development and manufacturing organization (CDMO), today announced a series of manufacturing deals with a Europe-based pharmaceutical company. The disclosed deals, worth over USD 668 million combined, will run through December 2031. The latest agreements bring up the company's cumulative contract value for this year to more than USD 4 billion. "We are delighted to expand our partnership with the European pharmaceutical company

Telix today announces it will expand its theranostic pipeline with new assets targeting Fibroblast Activation Protein (FAP), one of the most promising pan-cancer targets in nuclear medicine. Telix’s development program will initially focus on the treatment of bladder cancer, rounding out its urology franchise, which includes late-stage therapeutic programs for kidney and prostate cancers. FAP is a pan-cancer marker expressed in the tumour microenvironment of epithelial cancers

TAHO Pharmaceuticals Ltd. announced the dosing of the first subjects in its U.S. Phase III clinical trial for its lead product, TAH3311, an innovative antithrombotic oral dissolving film (ODF). In July 2023, the U.S. Food & Drug Administration (FDA) accepted TAHO's proposal for a 505(b)(2) NDA submission, based on a single pivotal bioequivalence study comparing the plasma concentration of TAH3311 to the approved tablet formulation. This pivotal, open-label, randomized, crossover trial