Aug. 3, 2026 -- GlycoNex Inc. (TPEx: 4168) today announced that the first patient has been successfully dosed in the First-in-Human (FIH) Phase I clinical trial of GNX1021, the Company's novel glycan-targeting antibody-drug conjugate (ADC), in Japan. The milestone marks GNX1021's transition into clinical development and initiates the generation of the first human data for the Company's lead oncology asset. The start of dosing represents an important value inflection point for GlycoNex. It advan

The FDA Division of Neurology provided positive feedback supporting a regulatory pathway for Privosegtor in acute multiple sclerosis (MS) relapses, addressing a significant unmet medical need The FDA confirmed that existing Privosegtor data can be cross-referenced for a new Investigational New Drug (IND) application in acute MS relapses, planned for submission in the fourth quarter of 2026 Privosegtor, a novel neuroprotective candidate, continues to advance across core neuro-ophthalmology indic

MELBOURNE, Australia and OXFORD, United Kingdom, Aug. 03, 2026 (GLOBE NEWSWIRE) -- Aravax, a clinical-stage biotechnology company developing next-generation, disease-modifying immunotherapies for food allergy, today announces it has received Fast Track designation from the US Food and Drug Administration (FDA) for its lead product, PVX108 for the treatment of peanut allergy. The FDA’s Fast Track program facilitates the expedited development and review of new drugs or biologics that are intended

Aug. 02, 2026 -- Nanjing Leads Biolabs Co., Ltd. (“Leads Biolabs” or the “Company,” Stock Code: 9887.HK) today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has approved the investigational new drug (IND) application for an open-label, multicenter Phase Ib/II clinical trial of its proprietary PD-L1/4-1BB bispecific antibody, Opamtistomig (LBL-024), in combination therapy for metastatic colorectal cancer (mCRC). The study is designed to

RAG-1C achieves dual IND clearances from both U.S. FDA and China CDE, paving the way for global clinical development of the world's first saRNA therapy for ocular diseases RAG-1C utilizes Ractigen's clinically validated LiCO™ platform to target p21 gene activation for long-lasting anti-fibrotic efficacy July 31, 2026 -- Ractigen Therapeutics, a pioneer and global leader in small activating RNA (saRNA) therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has cleared its

Repatha is the Only PCSK9 Inhibitor Proven to Significantly Reduce Risk of First Heart Attack and Stroke in Phase 3 Clinical Trial, Setting a New Benchmark in Cardiovascular Risk Reduction Recommendation Based on the Landmark Phase 3 Global VESALIUS-Cardiovascular Trial of More Than 12,000 Patients July 29, 2026 -- Amgen (NASDAQ: AMGN) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Repatha® (evo

Aug. 3, 2026 -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olomorasib as a monotherapy for the treatment of adult patients with advanced pancreatic cancer who have received at least one prior systemic therapy and have a KRAS G12C mutation, as determined by an FDA-approved test. Olomorasib is an investigational, potent and highly selective next-generation inhibitor of KRAS G12C. Olomorasib was

Generally well-tolerated with no serious adverse events, bronchospasm or diarrhea; no study drug discontinuations 90% of patients had no [60%] or mild [30%] cough ~450 total inhalations administered in patients with IPF Global Phase 2 INFLO-2 trial actively enrolling patients Conference call and webcast scheduled for July 29 at 4:30 p.m. ET July 29, 2026 -- MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company focused on developing innovative, patient-centric therapies for chronic d

Successful initiation of the Phase 2/3 clinical trial of SIL204 at Tel Aviv Sourasky Medical Center (“TASMC” or “Ichilov”), one of Israel’s largest and most prominent academic medical centers, clears the site to commence patient screening Milestone marks the start of Silexion’s transition of the SIL204 program from regulatory preparation into active clinical execution, following the Company’s previously announced regulatory authorizations from the Israeli Ministry of Health and Germany’s Feder

RMAT designation is intended to help expedite development of new regenerative medicines that have potential to treat serious medical conditions with significant unmet need The designation could accelerate OCU410’s regulatory path while further differentiating its one-time treatment for life approach from current therapies requiring chronic administration July 29, 2026 -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness di