Regulatory and Compliance Updates news (page 4)

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  16 January 2026

  Johnson & Johnson's CAPLYTA® Shows Promise for Remission in Major Depressive Disorder

  CAPLYTA® nearly doubles remission rates in major depressive disorder when used with antidepressants, showing sustained benefits over six months in clinical studies.
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  16 January 2026

  Boliden Seeks EU Strategic Project Status for Nautanen

  Boliden aims to develop Nautanen copper deposit as a sustainable mine, enhancing EU's green transition. Production may start in the early 2030s, pending permits and feasibility studies.
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  14 January 2026

  Johnson & Johnson's TECVAYLI® Shows Improved Survival in Multiple Myeloma Patients

  TECVAYLI® monotherapy reduces disease progression and death risk in multiple myeloma patients refractory to anti-CD38 and lenalidomide, showing superior survival benefits.
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  13 January 2026

  WuXi Biologics Gains UK MHRA GMP Certification for Ophthalmic Biologic Manufacturing

  Two WuXi facilities in Wuxi passed UK MHRA inspection with no critical findings, confirming their global GMP compliance and robust quality systems.
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  8 January 2026

  SkyNRG Advances Project Wigeon with Key Environmental Approvals

  Project Wigeon secures environmental approvals, moving to engineering phase. Facility to produce SAF from RNG, reducing emissions and boosting local economy by 2030.
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  6 January 2026

  Johnson & Johnson Seeks EMA Approval for TECVAYLI and DARZALEX Combo in Relapsed Multiple Myeloma

  The EMA application is based on Phase 3 data showing improved survival in relapsed multiple myeloma with TECVAYLI and DARZALEX, with similar adverse event rates to standard care.

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  5 January 2026

  WuXi Biologics Earns ISO 20400 for Sustainable Procurement

  Achieving ISO 20400, the company integrates sustainability in procurement, enhances supply chain resilience, and commits to net-zero goals with recognized ESG efforts.
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  5 January 2026

  Takeda and Protagonist Submit NDA for Rusfertide in Polycythemia Vera Treatment

  Rusfertide shows promise in controlling hematocrit and reducing phlebotomy in PV patients, meeting key endpoints in Phase 3 VERIFY study.
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  31 December 2025

  Novo Nordisk Wins Semaglutide Patent Case in China

  China's Supreme Court upholds the semaglutide patent, boosting confidence in foreign medical innovation and supporting sustainable development in China.
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  24 December 2025

  Elkem Reports Fatality After Explosion at Saint-Fons Workshop

  An explosion at a Saint-Fons site resulted in one death and three injuries. Operations are halted, and investigations are underway. Psychological support is provided to affected employees.
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  23 December 2025

  Worley Rosenberg Wins EPC Contract for ConocoPhillips Project

  EPC contract covers modifications at Ekofisk Complex. FEED completed; EPC starts Jan 2026, ends autumn 2028. Part of Albuskjell, Vest Ekofisk, Tommeliten Gamma redevelopment. Regulatory approval pending.
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  22 December 2025

  FDA Approves Novo Nordisk's Oral Wegovy for Adult Weight Loss

  FDA approves Wegovy pill, the first oral GLP-1 for weight loss, showing ~17% loss in trials. Available January at $149/month, it also reduces cardiovascular risks in adults with obesity.
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  22 December 2025

  Novo Nordisk: FDA Approves Wegovy® Oral Pill for Weight Management

  Wegovy® pill, an oral GLP-1, shows 16.6% weight loss in trials. Launch expected in the US by January 2026. Approval based on OASIS and SELECT trials.
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  22 December 2025

  EC Approves Johnson & Johnson's TREMFYA® for Treating Plaque Psoriasis in Children

  TREMFYA® gains EC approval for treating moderate to severe plaque psoriasis in children, marking the first IL-23 inhibitor for pediatric use.
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  22 December 2025

  Roche's Lunsumio VELO Approved by FDA for Subcutaneous Use in Follicular Lymphoma

  Lunsumio VELO cuts treatment time to one minute for relapsed follicular lymphoma, offering outpatient care with a manageable safety profile.
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  19 December 2025

  WuXi Biologics Earns CDP "A" Ratings for Climate and Water

  Recognized for environmental leadership, achieving net-zero by 2050, and reducing water use by 30% by 2025. Collaborates with suppliers for sustainable practices.
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  18 December 2025

  FDA Approves Boehringer Ingelheim's JASCAYD for Progressive Pulmonary Fibrosis

  JASCAYD, a PDE4B inhibitor, slows lung function decline in progressive pulmonary fibrosis, offering a new treatment option based on Phase III trial results.
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  18 December 2025

  Johnson & Johnson's TRUFILL n-BCA Approved by FDA for Chronic Subdural Hematoma Treatment

  FDA approves TRUFILL n-BCA for MMA embolization in chronic subdural hematoma, offering a minimally invasive alternative to surgery with proven safety and effectiveness.
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  18 December 2025

  Lilly's Orforglipron Maintains Weight Loss in Phase 3 Trial

  Orforglipron met primary and key secondary endpoints for weight maintenance at 52 weeks post-weight loss on Wegovy. FDA submission for obesity treatment is underway.
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  18 December 2025

  Novo Nordisk Seeks FDA Approval for CagriSema, a Weekly Obesity Treatment

  CagriSema, combining cagrilintide and semaglutide, shows 23% weight loss in trials. If approved, it offers a new obesity treatment option.
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  18 December 2025

  Novo Nordisk Seeks FDA Approval for CagriSema, a Weekly Obesity Treatment

  CagriSema, a weekly injectable combining GLP-1 and amylin analogues, shows promising weight loss results in trials and awaits FDA review for obesity management.
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  18 December 2025

  Takeda's Zasocitinib Phase 3 Trials Show Promise for Plaque Psoriasis Treatment

  Zasocitinib met all primary and secondary endpoints in Phase 3 trials, showing potential for clear skin in plaque psoriasis with a consistent safety profile.
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  17 December 2025

  Aptar's Bidose System Delivers FDA-Approved CARDAMYST Nasal Spray for PSVT

  CARDAMYST, a self-administered nasal spray for PSVT, offers reliable, easy-to-use treatment with Aptar's protective dual-container system, enhancing drug delivery solutions.
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  17 December 2025

  Johnson & Johnson's RYBREVANT FASPRO™ Gains FDA Approval for Faster NSCLC Treatment

  FDA approves RYBREVANT FASPRO™ for EGFR-mutated NSCLC, offering faster, subcutaneous administration with fewer side effects compared to IV delivery.
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  17 December 2025

  Merck's KEYTRUDA and Padcev Enhance Survival in Cisplatin-Eligible MIBC Patients

  KEYTRUDA and Padcev improve survival and response rates in MIBC patients, showing promise as perioperative treatment with consistent safety profiles.
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  17 December 2025

  Commission Enhances Carbon Border Adjustment Mechanism

  The EU expands CBAM to more products, introduces anti-circumvention measures, and launches a fund to support EU producers against carbon leakage.
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  16 December 2025

  EU Proposes Measures to Boost Health Sector Innovation and Resilience

  The EU introduces a Biotech Act, Safe Hearts Plan, and medical device reforms to enhance biotech, tackle cardiovascular diseases, and streamline regulations for innovation and patient safety.
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  16 December 2025

  PPG Secures REDCert² Certification for Sustainable Materials at European Sites

  PPG's Amsterdam and Søborg sites achieve REDCert², ensuring sustainable raw material use and supporting customers' environmental goals with high-performance products.
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  16 December 2025

  Equinor Challenges Økokrim Penalty

  Equinor disputes a NOK 220M fine and NOK 500M confiscation claim for historical emissions, arguing it self-reported and addressed the issues. The case will proceed to court.
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  15 December 2025

  Janssen's TECVAYLI® and DARZALEX FASPRO® Join FDA's Priority Voucher Program

  TECVAYLI® and DARZALEX FASPRO® show significant survival benefits in multiple myeloma, gaining FDA Breakthrough Therapy Designation and Real-Time Oncology Review.