July 1, 2026 -- SciBase Holding AB ("SciBase") (STO: SCIB) a leader in AI-based devices for detection and prevention in dermatology, today announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking to expand the U.S. indication for Nevisense to include the assessment of Non-Melanoma Skin Cancers (keratinocyte skin cancers). Nevisense is currently the only FDA-approved AI-driven technology in dermatology for the assessment and early detecti

INTENT Biologics, a clinical-stage biotechnology company developing first-in-class exosome-based biologic therapies for serious conditions with significant unmet medical need, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for PEP Biologic™ for the treatment of diabetic foot ulcers (DFU) under IND 019567. FDA Breakthrough Therapy designation is intended to expedite the development and review of truly innovative new therapeutic drugs

The approval of TREGZI, clinically known as Orca-T®, marks a significant milestone for patients as a novel, personalized cell therapy for use in a stem cell transplant to improve survival free of chronic graft versus host disease (GVHD) in adults with hematological malignancies Approval is based on the pivotal Precision-T study which demonstrated patients receiving TREGZI were twice as likely to be alive without chronic GVHD at one year compared with conventional allogeneic transplant TREGZI i

Diranersen presentation will feature Phase 2 CELIA data in early Alzheimer’s disease, including clinical, biomarker and safety results for Biogen’s investigational tau-targeting ASO, following topline results announced in May 2026 Lecanemab presentations will highlight emerging data on subcutaneous administration and real-world use, including practical treatment considerations, at-home administration, three-year LEADER data, maintenance dosing and patient experience Advances across Biogen’s Alzh

EMERGE is a global, randomized, multicenter, placebo-controlled Phase 3 trial that will evaluate claseprubart 300mg/2mL S.C. dosed Q2W and Q4W vs. placebo, with top-line results anticipated in 2H’28 Advancing a neuromuscular franchise with claseprubart, a highly potent investigational classical pathway inhibitor, across generalized Myasthenia Gravis (gMG), Multifocal Motor Neuropathy (MMN) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), with best-in-disease, pipeline-in-a-product

A Marketing Authorisation Application with the European Medicines Agency is also under regulatory review for approval June 29, 2026 -- Nuvation Bio (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (U.K.) has validated the Marketing Authorisation Application (MAA) submitted by its partner Eisai Co, Ltd. (Headquarters: Tokyo, CEO

47 total developmental milestones gained across 10 participants, with durable treatment effect and no plateau or milestone loss through 30 months of follow-up 100% of participants improved in CGI-I score and gained ≥1 developmental milestone, with an average of 4.7 milestones per participant, and all gaining ≥1 developmental milestone in the past 12 months Developmental milestones were gained in a progressive, stepwise sequence, suggesting a restart of development post-treatment NGN-401 at the 1

Anivive converts Laverdia-CA1 to full FDA approval First FDA-approved product to validate Anivive's AI-enabled development model — from drug repurposing through clinical trial enrollment Affordable oral lymphoma treatment administered at home Additional approvals underway in Australia, Brazil, Canada, Europe, Japan and the United Kingdom June 26, 2026 -- Anivive Lifesciences today announced that the U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine has granted full approval

First randomized, double-blind, placebo-controlled trial to demonstrate treatment-associated reduction of TDP-43 in people living with ALS TDP-43 pathology is present in more than 97% of ALS cases and is widely recognized as a central driver of disease progression PrimeC demonstrates target engagement with consistent effects across clinical outcomes, survival, and biomarkers, supporting its potential as a disease-modifying therapy June 29, 2026 -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("N

VR-205 Met Primary Endpoint and Key Secondary Endpoints and Was Well Tolerated VR-205 Efficacy and Safety Profile in Japanese Patients Was Consistent with the Profile Observed in Global Studies Japanese New Drug Application Submission Targeted by End of 2026 June 29, 2026 -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced positive top-line results from a Phase 3 clinical trial evaluating the efficacy and safety of VR-205 (targeted-release budesonide formulation) (Nefec