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DARZALEX FASPRO® quadruplet approved in U.S. for transplant-ineligible multiple myeloma patients

Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for the treatment of adult patients with...

Correction — Privo Technologies

Privo Technologies, Inc. announced the successful completion of its Phase 1/2 clinical evaluation of PRV211, a first-in-class intraoperative chemotherapy patch for head and neck cancer patients. The study demonstrated excellent safety outcomes...

HanchorBio Partners with WuXi Biologics to Advance Next-Generation Fusion Protein Pipeline

HanchorBio, Inc. a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, and WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing...

BIOCORNEUM® announces the availability of its new dual-action bruise system designed to enhance post-procedure recovery

BIOCORNEUM®, the leading brand in professional scar and skin recovery, announced the immediate availability of its new Bruise Care System. The innovative dual-approach regimen is designed to help patients prepare for and recover more quickly from...

Alamar Biosciences announces the launch of the NULISAqpcr™ AD 5-plex assay, advancing blood-based biomarker detection for Alzheimer’s disease research

Alamar Biosciences, Inc. a leader in precision proteomics dedicated to advancing the early detection of disease, is proud to announce the launch of its Research Use Only (RUO) NULISAqpcr™ AD 5-plex Assay. This innovative solution enables...

Ad Hoc Analyses Indicate Enhanced Survival Outcomes with VYLOY™ (zolbetuximab) Combined with Chemotherapy When Common Adverse Events Are Properly Managed

Astellas Pharma U.S., Inc. announced the publication of exploratory ad hoc analyses from the combined Phase 3 SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) studies in patients with HER2-negative, CLDN18.2-positive advanced gastric or...

PureWay and PPSWG Form New Partnership to Transform Pharmaceutical Waste Management in the U.S.

In a move set to strengthen the nation's approach to pharmaceutical waste management, PureWay and the Pharmaceutical Product Stewardship Work Group (PPSWG) announced a strategic collaboration to improve safety, compliance, and sustainability in...

FDA Approves New 2-Gram Fibryga® Presentation to Improve Convenience and Precision in Treating Acquired Fibrinogen Deficiency

Octapharma USA, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a new 2-gram presentation of Fibryga®, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for fibrinogen replacement in patients with acquired...

Ark Biopharmaceutical Granted China Marketing Authorization for Aizhida in ADHD Treatment

Shanghai Ark Biopharmaceutical Co., Ltd. announced that China's National Medical Products Administration (NMPA) has approved the New Drug Application for Serdexmethylphenidate Chloride and Dexmethylphenidate Hydrochloride Capsules (Aizhida) for...

Novotech Appoints Anand Tharmaratnam as Chief Executive Officer

Novotech, a globally recognized full-service biotech clinical research organization (CRO), is pleased to announce the appointment of Dr. Anand Tharmaratnam as its new Chief Executive Officer. Dr. Tharmaratnam brings nearly three decades of...

Coya Therapeutics Announces Results from an Investigator-Initiated Study Showing Treg Enhancement and Cognitive Stability in Frontotemporal Dementia Patients Treated with Low-Dose IL-2 and CTLA4-Ig

Coya Therapeutics, Inc. a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with neurodegenerative disorders, announced positive results of an investigator-initiated...

RoslinCT and BOOST Pharma Form Strategic Manufacturing Partnership to Advance Cell Therapy for Osteogenesis Imperfecta

RoslinCT, a global contract development and manufacturing organization (CDMO) specializing in advanced cell therapies, and BOOST Pharma, a clinical-stage biotechnology company developing first-in-class cell therapies for rare paediatric skeletal...

Orum Therapeutics Names Chad May Chief Scientific Officer to Advance Degrader-Antibody Conjugate Programs

Orum Therapeutics a biotechnology company pioneering the field of degrader-antibody conjugates (DACs), today announced the appointment of Chad May, Ph.D., as Chief Scientific Officer (CSO). Dr. May brings more than 20 years of oncology and...

Peer-reviewed validation of a 60-channel closed-loop neurostimulation brain implant is published by Nia Therapeutics

Nia Therapeutics announced publication in Brain Stimulation of the first in vivo validation of its Smart Neurostimulation System (SNS), a wireless, implantable brain-computer interface designed for closed-loop treatment of memory disorders. The...

Matisse Pharmaceuticals receives INN for M6229, recognizing it as a first-in-class drug, isupartob sodium

Matisse Pharmaceuticals B.V., a clinical stage company developing a medicinal product for the treatment of sepsis, announced that Matisse’s lead compound M6229, has received the International Non-proprietary Name (INN) isupartob sodium from the...

Medra Raises $52 Million in Series A Funding to Build Physical AI Scientists

Medra, the company developing the first platform for Physical AI Scientists, announced a $52 million Series A financing led by Human Capital, with participation from existing investors Lux Capital, Neo, and NFDG, alongside new investors Catalio...

Voranigo® (vorasidenib) from Servier has received multiple regional Prix Galien Awards

Servier, an independent international pharmaceutical group governed by a foundation, announced that Voranigo® (vorasidenib) has been awarded the inaugural 2025 Prix Galien Bridges Award for Best Product for Orphan/Rare Diseases, during a ceremony...

Health Canada has granted Celltrion approval for Eydenzelt®, a biosimilar referencing Eylea® (aflibercept 2mg).

Celltrion, Inc. announced that Health Canada has approved Eydenzelt®, a biosimilar referencing Eylea® (aflibercept 2mg), in both vial and pre-filled syringe format, for treatment of all indications approved for Eylea. “Today’s approval lays a...

Samsung Bioepis Announces the Launch of Denosumab Biosimilars, OBODENCE™ and XBRYK™, in Europe

Samsung Bioepis Co., Ltd. announced the launch of OBODENCE™ (60 mg pre-filled syringe) and XBRYK™ (120 mg vial), denosumab biosimilars referencing Prolia and Xgeva. The products will be commercially available in Europe in December 2025 and January...

Menarini Group Shares New Data on ELZONRIS® (tagraxofusp-erzs)

The Menarini Group a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer...