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To advance gene therapy development and manufacturing, ProBio has launched GMP AAV manufacturing services at its Hopewell facility

ProBio, a leading contract development and manufacturing organization (CDMO) specializing in gene and cell therapy, announced the launch of its cGMP Adeno-Associated Virus (AAV) manufacturing services at its 128,000 sq. ft. state-of-the-art...

Jazz Pharmaceuticals announces the U.S. FDA approval of Modeyso™ (dordaviprone) as the first and only treatment for recurrent H3 K27M-mutant diffuse midline glioma

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...

FDA approves Apellis' EMPAVELI® (pegcetacoplan) as the first treatment for patients aged 12 and older with C3G and primary IC-MPGN

Apellis Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved EMPAVELI® (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis...

Dash Bio Secures $11M to Accelerate a New Era in Bioanalysis, Bringing Total Funding to $17.5M

Dash Bio, a preclinical and clinical bioanalysis company reinventing the speed and scalability of drug development, announced it has raised an additional $11 million in funding, bringing its total raised to $17.5 million. The new financing was led...

BD Announces the First Pharma-Sponsored Clinical Trial Using BD Libertas™ Wearable Injector Technology for Biologic Drugs

BD (Becton, Dickinson and Company) a leading global medical technology company, announces the first pharma-sponsored combination product clinical trial using the BD Libertas™ Wearable Injector for subcutaneous delivery of complex biologics. The...

Klotho Neurosciences, Inc. Partners with AAVnerGene Inc. to Make Gene Therapy Assets of Klotho Available

Klotho Neurosciences, Inc. announced that it is partnering with AAVnerGene Inc. (AAVnerGene), a Rockville, MD-based innovation-driven biotech renowned for its transformative technologies in AAV manufacturing and tissue-targeted delivery. Dr....

Made Scientific and Sentinel BioTherapeutics Announce a Strategic Manufacturing Partnership to Advance the Phase I/II Allogeneic ePP Encapsulated Cell Therapy Program

Made Scientific, a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO), and Sentinel BioTherapeutics, a clinical-stage biotechnology company advancing encapsulated cell-based immunotherapies for solid tumors,...

Sun Pharma Announces the Launch of LEQSELVI™ (deuruxolitinib) in the United States for Treating Severe Alopecia Areata

Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or affiliated companies, "Sun Pharma") announced LEQSELVI™ (deuruxolitinib) 8 mg tablets is now available...

Hengrui’s Heng Qin® (Perfluorohexyloctane Eye Drops) Approved as the First Treatment for Dry Eye Disease Associated with MGD—A Breakthrough in Ophthalmology

Jiangsu Hengrui Pharmaceuticals Co., Ltd. a global pharmaceutical company focused on scientific and technological innovation, and Novaliq GmbH (“Novaliq”), a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based...

Phase 1/2 Clinical Study of Novel EGFR/HER3 Bispecific Antibody-Drug Conjugate AVZO-1418/DB-1418 Begins with First Patient Dosed

Duality Biotherapeutics' partner Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, announced the first patient has been dosed in the Phase 1 portion of a Phase 1/2 clinical...

The European Commission grants Aurobindo Pharma approval to market the cancer drug, Dazublys

Aurobindo Pharma has received marketing authorisation for its cancer treatment medication Dazublys. In an exchange filing, the company said that CuraTeQ Biologics, a wholly owned subsidiary of the company dedicated to oncology and immunology...

Fresenius Expands Biosimilars Portfolio with Denosumab Launch in the U.S

Fresenius announced that its operating company Fresenius Kabi, has introduced two new biosimilars - Conexxence® (denosumab-bnht) and Bomyntra® (denosumab-bnht) - in the United States. These denosumab biosimilars are approved by the FDA for all...

Innovent Announces Approval from China's NMPA for Mazdutide, the First Dual GCG/GLP-1 Receptor Agonist, for Chronic Weight Management

Innovent Biologics, Inc. a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major...

With New Offerings Like MIC+B12 Injections, Metformin Combinations, and More, Shed Expands Its Weight Management Support

Shed, a modern wellness company focused on helping individuals feel and function their best, announces the launch of several new products designed to provide affordable, weight management support options for individuals at every stage of their...

enGene’s Detalimogene Receives RMAT Designation from the FDA, Opening the Path for Expedited Review in High-Risk, Non-Muscle Invasive Bladder Cancer

enGene Holdings Inc. a clinical-stage, non-viral gene-based immunotherapy company, announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to detalimogene voraplasmid (also...

Kashiv BioSciences Announces Positive Topline Results from the Confirmatory Efficacy Study of ADL-018, a Biosimilar Candidate to XOLAIR® (omalizumab).

Kashiv BioSciences, LLC announced positive topline results from its confirmatory clinical efficacy and safety clinical trial evaluating ADL-018, a proposed biosimilar to XOLAIR® (omalizumab). The randomized, double-blind, multicenter study...

Space Cargo Unlimited and Exobiosphere Partner for High-Throughput Space Biotech

Exobiosphere S.à r.l. and Space Cargo Unlimited today announced the signing of a Memorandum of Understanding (MoU) during the Paris Air Show to launch joint space missions focused on high-throughput biotechnology research. High-throughput...

Boehringer Ingelheim and the Lung Cancer Research Foundation Announce New Research Collaboration

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...

Ratio Therapeutics partners with Macrocyclics for exclusive production and global distribution of its Macropa™ radiopharmaceutical platform

Ratio Therapeutics Inc. (Ratio), a pharmaceutical company employing innovative technologies to develop best-in-class radiopharmaceuticals for cancer treatment and monitoring, announced today that it entered into an agreement granting Macrocyclics...

Genmab: Epcoritamab combo shows high response in R/R DLBCL patients eligible for ASCT

Genmab A/S announced new results from the Phase 1b/2 EPCORE® NHL-2 trial Arm 10 (NCT04663347), evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, in combination with rituximab, ifosfamide, carboplatin, and...