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NewsFDA Resurfaces ICH M3(R2) Guidance on Nonclinical Safety Studies
FDA re-surfaces ICH M3(R2) nonclinical safety guidance; regulatory teams should audit study packages against current harmonized standards.
Novo Nordisk Rebinyn Obtains Fda Approvals For Hemophilia B Cases
FDA OTAT Launches Gene Therapy CMC Town Hall Series
ProQR Therapeutics Doses First Participant in Phase 1 Study of AI-Discovered RNA Editing Candidate AX-0811
Propanc Biopharma Targets February 2027 First-in-Human Phase 1b Study of PRP in Solid Tumors
Latest news
11 storiesCellipont Bioservices and Xiogenix Publish Fill-Finish White Paper for Scalable Cell Therapy Manufacturing
Cellipont and Xiogenix publish fill-finish performance data showing 17-fold scale consistency on the ARES™ X20+ platform for cell therapy manufacturing.
Bayer Gains FDA Accelerated Approval for Sevabertinib in First-Line HER2-Mutant NSCLC
FDA expands sevabertinib's accelerated approval to first-line HER2-mutant NSCLC, reviewed concurrently with MHRA under Project Orbis.
CDSCO Shifts To Risk-Based Drug Approvals To Ease Compliance
CDSCO signals a shift to risk-based drug approvals, with Joint Drug Controller Dr. Ranga Chandrashekhar confirming a review of intervention points across approval pathways.
Just Evotec Advances JST-018 Orthopoxvirus Cocktail To Phase 1
Just Evotec Biologics advances JST-018 orthopoxvirus antibody cocktail into Phase 1, validating continuous bioprocessing for cGMP biodefense manufacturing.
ProBioGen & Transgene Expand Virus-Based Therapy Manufacturing
ProBioGen and Transgene expand their CDMO partnership to improve viral vector manufacturing productivity and reduce process costs as pipeline programmes scale.
Onyx Scientific Expands UK API Capacity With £1.5M Investment
Onyx Scientific commits £1.5M to expand its UK GMP API facility from six to ten suites, adding contract manufacturing capacity.
Rezubio Begins Phase I Trial Of Inhaled Respiratory Drug RZ-520
Rezubio doses first patients in Phase I trial of RZ-520, an inhaled drug designed to sustain pulmonary exposure while limiting systemic distribution.
Elix & Axcelead Partner to Accelerate Protein Degrader Discovery
Elix and Axcelead DDP formalise a research agreement combining generative AI with TPD expertise to address challenging drug targets.
Neurizon Appoints Dr. Chris Bremer As CEO To Lead Strategy
Neurizon names Dr. Chris Bremer CEO, bringing 20+ years of pharma and biotech leadership across drug development and commercialisation.
Inhibitor Therapeutics Updates FDA Strategy for Itraconazole
Inhibitor Therapeutics proposes surgically eligible BCCs as primary endpoint and seeks FDA guidance on using Tang placebo data as external control for its BCCNS itraconazole program.
Assembly Bio Exercises 40% US Profit Option With Gilead On HSV
Assembly Biosciences exercises 40% U.S. profit-share option with Gilead for its HSV helicase-primase inhibitor program, with Phase 2 initiation targeted by end of 2026.
Worth your time this week
Inventiva Presents Five Lanifibranor Abstracts At Paris MASH 2026
FDA Updates DDT Metrics: 160 Projects Active As Of July 2026
FDA Maps 4 Approval Pathways For Blood Products
