2025
Lilly Expands Gene Therapy Presence with Acquisition of Adverum Biotechnologies
Eli Lilly; Adverum Biotechnologies; gene therapy; ophthalmology; wet age-related macular degeneration; ixovec; acquisition; contingent value rights
FDA Approves GSK’s Blenrep for Multiple Myeloma Treatment, Marking a Market Return
Blenrep; GSK; FDA Approval; Multiple Myeloma; Bortezomib; Dexamethasone
FDA Rejects Sydnexis Myopia Drug for Kids; Chugai to Buy Renalys for $98M Upfront
FDA; SYD-101; Sydnexis; myopia; pediatric; complete response letter; Chugai; Renalys; acquisition; $98M; ophthalmology
FDA Publishes New Filing Checklists to Prevent Drug Submission Delays
FDA; filing checklist; drug application; submission delays; New Drug Application (NDA); Abbreviated New Drug Application (ANDA); Complete Response Letters; regulatory guidance
Inhibrx to Seek FDA Approval in 2026 After Strong Phase 2 Data for Bone Cancer Drug Ozekibart
Inhibrx; FDA submission; ozekibart; INBRX-109; chondrosarcoma; bone cancer; phase 2 clinical trial; progression-free survival; death receptor 5; biologics license application; rare cancer; liver toxicity
Rani Therapeutics Appoints Abe Bassan and Vasudev Bailey to Board of Directors
Rani Therapeutics; Board of Directors; Abe Bassan; Vasudev Bailey; biotherapeutics; oral biologics delivery; Samsara BioCapital; Anomaly Ventures; Chugai collaboration; Board change
METiS BioTech Announces China’s First AI-Enabled Formulation Drug Candidate to Complete Phase III Clinical Trial
METiS BioTech; AI; drug formulation; Phase III; pseudobulbar affect (PBA); China; nanodelivery; AiTEM; clinical milestone
Thomson Reuters Approved for $27.5 Million Data Privacy Settlement for Selling Californians’ Personal Data
Thomson Reuters; CLEAR platform; data privacy; California residents; settlement; personal data; class action