Regulatory https://www.bioworld.com/rss en-us Competitive approach better than restricting deals with China? http://www.bioworld.com/articles/731827 Tue, 09 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731827-competitive-approach-better-than-restricting-deals-with-china China U.S. handshake NMPA gives conditional nods to drugs by Lupeng, Vcare, Staidson http://www.bioworld.com/articles/731712 Tue, 09 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731712-nmpa-gives-conditional-nods-to-drugs-by-lupeng-vcare-staidson Red wooden approved stamp Japan backs Oncolys virus therapy for esophageal cancer http://www.bioworld.com/articles/731711 Tue, 09 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731711-japan-backs-oncolys-virus-therapy-for-esophageal-cancer Illustration of cancer on the esophagus Wuxi Apptec insists it’s ‘not a Chinese military company’ http://www.bioworld.com/articles/731710 Tue, 09 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731710-wuxi-apptec-insists-its-not-a-chinese-military-company Wuxi Apptec signage Credit: Wuxi Apptec Gen1e Lifesciences receives US FDA designations for GEn-1123 http://www.bioworld.com/articles/731763 Tue, 09 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/731763-gen1e-lifesciences-receives-us-fda-designations-for-gen-1123 Art concept for inflamed human tissue Moderna’s mRNA-4194 cleared for clinic for Lynch syndrome http://www.bioworld.com/articles/731760 Tue, 09 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/731760-modernas-mrna-4194-cleared-for-clinic-for-lynch-syndrome Illustration of messenger RNA China deals highlight biopharma evolution, reports LEK http://www.bioworld.com/articles/731530 Tue, 09 Jun 2026 08:00:00 -0400 https://www.bioworld.com/articles/731530-china-deals-highlight-biopharma-evolution-reports-lek China map/flag with silhouettes of business people Competitive approach better than restricting deals with China? http://www.bioworld.com/articles/731692 Mon, 08 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731692-competitive-approach-better-than-restricting-deals-with-china China U.S. handshake China’s NMPA clears Hansoh’s HS-10541 for clinic http://www.bioworld.com/articles/731741 Mon, 08 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/731741-chinas-nmpa-clears-hansohs-hs-10541-for-clinic Art concept for tumor Amphista’s BRD9 degrader gains IND clearance for AML http://www.bioworld.com/articles/731739 Mon, 08 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/731739-amphistas-brd9-degrader-gains-ind-clearance-for-aml 3D illustration of acute myeloid leukemia cells FDA gets earful on CNPV pilot http://www.bioworld.com/articles/731633 Fri, 05 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731633-fda-gets-earful-on-cnpv-pilot FDA website and logo Credit: Postmodern Studio - stock.adobe.com SCOTUS breathes new life into skinny labels http://www.bioworld.com/articles/731619 Thu, 04 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731619-scotus-breathes-new-life-into-skinny-labels Generic drugs and bottle Sotio Biotech’s SOT-106 designated orphan drug for osteosarcoma http://www.bioworld.com/articles/731653 Thu, 04 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/731653-sotio-biotechs-sot-106-designated-orphan-drug-for-osteosarcoma Illustration of bone cancer in the knee Rubio reopening door with Gavi http://www.bioworld.com/articles/731543 Wed, 03 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731543-rubio-reopening-door-with-gavi Smartphone with webpage of Gavi, The Vaccine Alliance Credit: Timon - stock.adobe.com CSPC’s SYS-6063 gains Chinese trial clearance for SLE http://www.bioworld.com/articles/731596 Wed, 03 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/731596-cspcs-sys-6063-gains-chinese-trial-clearance-for-sle Concept art for systemic lupus erythematosus R&D BMS-Hengrui deal strikes panic in Washington http://www.bioworld.com/articles/731649 Tue, 02 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731649-bms-hengrui-deal-strikes-panic-in-washington U.S. Capitol building China launches long-awaited drug data protection rules http://www.bioworld.com/articles/731647 Tue, 02 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731647-china-launches-long-awaited-drug-data-protection-rules Cybersecurity data lock Fulcrum drops work on SCD drug pociredir; stock plummets http://www.bioworld.com/articles/731532 Tue, 02 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731532-fulcrum-drops-work-on-scd-drug-pociredir-stock-plummets Sickle cell illustration FDA advises leveraging what’s already known in gene therapy R&D http://www.bioworld.com/articles/731529 Tue, 02 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731529-fda-advises-leveraging-whats-already-known-in-gene-therapy-r-and-d DNA double helix illustration with section being removed in red FDA approves IND for Iovance’s TIL therapy IOV-5001 http://www.bioworld.com/articles/731580 Tue, 02 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/731580-fda-approves-ind-for-iovances-til-therapy-iov-5001 Microscope with laptop displaying histology image. Voyager’s tau-targeted gene therapy VY-1706 gains IND approval http://www.bioworld.com/articles/731578 Tue, 02 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/731578-voyagers-tau-targeted-gene-therapy-vy-1706-gains-ind-approval Tau neuron illustration Tau protein accumulating on neuron. Credit: Kenneth S. Kosik, University of California - Santa Barbara FDA clears Shionogi’s Xocova as first COVID-19 prevention pill http://www.bioworld.com/articles/731531 Tue, 02 Jun 2026 08:00:00 -0400 https://www.bioworld.com/articles/731531-fda-clears-shionogis-xocova-as-first-covid-19-prevention-pill Xocova blister pack Credit: Shionogi & Co. Ltd. Policy, aka politics, to have bigger role in US grants? http://www.bioworld.com/articles/731514 Mon, 01 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731514-policy-aka-politics-to-have-bigger-role-in-us-grants Gold dollar sign and gray question marks China launches long-awaited drug data protection rules http://www.bioworld.com/articles/731457 Fri, 29 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731457-china-launches-long-awaited-drug-data-protection-rules Cybersecurity data lock Replimune tries again with melanoma drug post FDA shakeup http://www.bioworld.com/articles/731453 Fri, 29 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731453-replimune-tries-again-with-melanoma-drug-post-fda-shakeup Skin exam BMS-Hengrui deal strikes panic in Washington http://www.bioworld.com/articles/731574 Fri, 29 May 2026 09:00:00 -0400 https://www.bioworld.com/articles/731574-bms-hengrui-deal-strikes-panic-in-washington U.S. Capitol building FDA accepts IND for Rest Therapeutics’ early PTSD candidate http://www.bioworld.com/articles/731494 Fri, 29 May 2026 09:00:00 -0400 https://www.bioworld.com/articles/731494-fda-accepts-ind-for-rest-therapeutics-early-ptsd-candidate PTSD chalk silhouette, man holding head TROP2 ADCs progress into first-line for lung, breast cancers http://www.bioworld.com/articles/731648 Thu, 28 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731648-trop2-adcs-progress-into-first-line-for-lung-breast-cancers Floating antibody drug conjugates TROP2 ADCs progress into first-line for lung, breast cancers http://www.bioworld.com/articles/731444 Thu, 28 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731444-trop2-adcs-progress-into-first-line-for-lung-breast-cancers Floating antibody drug conjugates FDA’s VRBPAC faces complex COVID-19 landscape http://www.bioworld.com/articles/731442 Thu, 28 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731442-fdas-vrbpac-faces-complex-covid-19-landscape COVID-19 vaccine vials on conveyor belt