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NewsCDSCO 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
ProBioGen & Transgene Expand Virus-Based Therapy Manufacturing
Onyx Scientific Expands UK API Capacity With £1.5M Investment
Rezubio Begins Phase I Trial Of Inhaled Respiratory Drug RZ-520
Latest news
11 storiesNeurizon 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.
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.
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.
Inventiva Presents Five Lanifibranor Abstracts At Paris MASH 2026
Inventiva presents five lanifibranor abstracts at Paris MASH 2026, with Phase 3 NATiV3 topline data expected Q4 2026.
FDA Updates DDT Metrics: 160 Projects Active As Of July 2026
FDA's September 2026 DDT metrics show 160 projects in development and 22 qualified to date, with biomarkers leading qualification output.
FDA Maps 4 Approval Pathways For Blood Products
FDA CBER governs blood products across four pathways: BLAs for plasma biologics, NDAs for collection solutions, PMAs and 510(k)s for devices.
FDA Clarifies CBER Control Over Blood NDA And ANDA Paths
CBER retains NDA and ANDA jurisdiction over select blood products. Regulatory leads should confirm center assignment before filing to avoid delays.
FDA Updates Biologics Library With CMC And GMP Reference Docs
FDA's CBER has updated its General Biologics Guidance Library, consolidating CMC, GMP, and submission documents QA and regulatory teams should reference routinely.
Alkem Launches Renocia Exo, India's First Patented Ginsenoside Exosome Hair Growth Serum
Alkem Laboratories launches Renocia Exo, India's first patented ginsenoside-exosome hair serum, targeting follicle biology with a multitargeted mechanism.
Ocugen Doses First Patient in Phase 3 ArMaDa3 Trial of OCU410 for Geographic Atrophy
Ocugen initiates phase 3 ArMaDa3 trial of AAV5 gene therapy OCU410 for geographic atrophy, targeting a 2028 BLA filing via single pivotal trial pathway.
Worth your time this week
Biocon Secures 10-Year Pertuzumab Supply Deal with Brazil Under PDP Framework
Veru Advances Sabizabulin into Phase 2 After Preclinical Data Shows Activity in Daraxonrasib-Resistant Pancreatic Cancer
GRI Bio Presents Phase 2a Data Mapping GRI-0621's Nine-Pillar Mechanism of Action in IPF
