How PDS0101 patent coverage reshapes competitive risk in HPV16 positive head and neck cancer development
PDS Biotechnology strengthens PDS0101 patent protection as Phase 3 strategy evolves. Discover what this changes for immunotherapy competition.
INTENT Biologics secures FDA pediatric waiver, clears path to late-stage DFU trial for PEP Biologic
The U.S. Food and Drug Administration (FDA) has granted INTENT Biologics a full pediatric study waiver for its lead candidate, PEP Biologic, under IND 019567. The waiver, part of an agreed Initial Pediatric Study Plan (iPSP), applies to the product’s adult-focused development for diabetic foot ulcers (DFUs), a serious chronic wound indication preparing for pivotal […]
Insilico, Hygtia Therapeutics to co-develop brain-penetrant NLRP3 inhibitor ISM8969 for CNS diseases
Clinical-stage biotechnology company Insilico Medicine (HKEX: 3696) and Hygtia Therapeutics, a Shenzhen Pengfu Fund–backed startup under Fosun Health Capital, have entered into an exclusive co-development and licensing agreement to jointly advance ISM8969, a novel brain-penetrant NLRP3 inhibitor for central nervous system diseases. The deal grants 50-50 worldwide rights to both companies, with Insilico eligible to […]
Adaptin Bio prepares Phase 1 glioblastoma trial following preclinical progress in brain cancer candidate
Find out how Adaptin Bio is preparing a Phase 1 glioblastoma trial and why its preclinical progress matters for brain cancer treatment innovation.
MAIA Biotechnology advances ateganosine cancer program with Phase 3 THIO-104 trial and 2026 catalyst timeline
Find out how MAIA Biotechnology is advancing ateganosine into Phase 3 and why its 2026 clinical milestones could reshape treatment options in lung cancer.
Lilly’s sofetabart mipitecan gets FDA Breakthrough Therapy designation for ovarian cancer
Eli Lilly and Company has received Breakthrough Therapy designation from the U.S. Food and Drug Administration for its investigational antibody-drug conjugate, sofetabart mipitecan, also known as LY4170156. The designation applies to adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received prior treatment with bevacizumab and mirvetuximab soravtansine. The novel […]
Can GSK’s $2.2bn acquisition of RAPT Therapeutics reshape the food allergy treatment landscape with ozureprubart?
GSK plc has signed a definitive agreement to acquire RAPT Therapeutics Inc., a clinical-stage biopharmaceutical company based in California, in a transaction valued at approximately $2.2 billion. The centerpiece of the deal is ozureprubart, a long-acting anti-IgE monoclonal antibody currently undergoing Phase IIb evaluation for the prophylactic treatment of food allergies. With topline data from […]
Naturmega’s Ruby-O shows bioavailability edge over standard fish oil in peer-reviewed trial
Naturmega’s Ruby-O Balance showed better triglyceride response at a lower dose than fish oil. Find out what this means for the future of omega-3 delivery.
Can ketamine treatment clinics like Serenity redefine psychiatric care delivery in suburban America?
Serenity expands ketamine therapy in Florida. Find out how this signals a shift in psychiatric care access and what clinicians are watching next.
Is ENHERTU plus pertuzumab on track to redefine first-line treatment in HER2-positive metastatic breast cancer?
EMA begins review of ENHERTU plus pertuzumab for first-line HER2-positive metastatic breast cancer. Find out what this means for frontline therapy options.