First selective MET inhibitor approved for patients with MET-amplified advanced gastric cancer or gastroesophageal junction adenocarcinoma in China July 02, 2026 -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application (NDA) for ORPATHYS® (savolitinib) has been granted conditional approval by the China National Medical Products Administration (“NMPA”) for the treatment of locally advanced or metastatic gastric cancer or gastroesophageal ju

July 1, 2026 -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of its Phase 2 clinical study to assess the safety and tolerability of crinecerfont in children aged 3 months to under 4 years with classic congenital adrenal hyperplasia (CAH). Crinecerfont, marketed as CRENESSITY®, is approved in the United States as an adjunctive treatment to glucocorticoid replacement to control androgens in adult and pediatric patients 4 years of age and older with classic CAH. "Infa

92Bio, Inc. (www.92biotech.com), a clinical-stage biotechnology company developing next-generation T-cell engaging antibodies (TCEs), today announced dosing of the first patient in a Phase 1 clinical trial evaluating NTB-928 for the treatment of platinum-resistant ovarian cancer. The trial is being conducted at multiple US sites, with the first patient dosed at START New York-Long Island under the direction of Principal Investigator Dr. Geraldine O'Sullivan Coyne, MD. NTB-928 combines an affini

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