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

Oversubscribed $225 million concurrent private investment in public equity ("PIPE") with available cash to the combined company at closing anticipated to fund TALA-125 through a Phase 2b proof-of-concept study data readout in the second half of 2028 Talawar, the first company formed to develop and commercialize assets discovered by Khanda Therapeutics, L.P. ("Khanda"), is developing TALA-125, a novel anti-IL-13 × anti-IL-18 bispecific antibody for atopic dermatitis, with clinical entry expected

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

The star of Ipsen’s acquisition is an MDM2 blocker being proposed as an add-on therapy to ruxolitinib for myelofibrosis. The drug could be available to patients “as early as 2028,” according to Ipsen CEO David Loew. Ipsen will absorb California-based Kartos Therapeutics in a back-heavy agreement that will give the French biotech a late-stage drug candidate for a rare blood cancer. The deal involves a $450 million upfront payment from Ipsen, according to a news release on Monday morning. The co

Acquisition adds YUPELRI® (revefenacin), the first and only approved nebulized long-acting muscarinic antagonist (LAMA) for the maintenance treatment of COPD to Zymeworks' portfolio Acquisition of Theravance Biopharma at $17 per share is supported by an innovative non-recourse financing structure that enhances shareholder value by minimizing Zymeworks’ net capital at risk Transaction expected to be accretive to earnings and cash flow upon closing. YUPELR® U.S. profit share and ex-U.S. royalti

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