Regulatory and Compliance Updates news

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  19 February 2026

  Merck Reports Positive Phase 3 Trial Results for ENFLONSIA in High-Risk Infants and Children

  ENFLONSIA shows consistent safety and efficacy in high-risk infants over two RSV seasons, supporting expanded use for children under 2.
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  19 February 2026

  AGC Biologics Gains Anvisa GMP Certification for Seattle Facility

  The Seattle site can now supply biopharmaceuticals to Brazil, enhancing AGC's global supply capabilities and expanding regulatory approvals to over 11 countries.
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  18 February 2026

  Toray's Ehime and Nagoya Plants Achieve ISCC PLUS Certification for Engineering Plastics

  Two plants gain ISCC PLUS certification, enabling use of biomass and recycled materials in PBT and LCP resins, supporting carbon footprint reduction.
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  18 February 2026

  Johnson & Johnson's RYBREVANT FASPRO™ Gains FDA Breakthrough Status for Advanced Head and Neck Cancer

  FDA grants Breakthrough Therapy Designation to RYBREVANT FASPRO™ for HPV-unrelated head and neck cancer after platinum-based chemotherapy and PD-1/PD-L1 inhibitor.
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  18 February 2026

  PureCycle and TOPPAN Partner for Sustainable Recycled Packaging Solutions

  They developed a snack bar wrapper with 30% recycled content, targeting thermoforming applications to meet regulatory demands without compromising safety or performance.
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  18 February 2026

  VolagHy Releases EIA Program for Kuopio Site

  The EIA program for the Kuopio site outlines environmental, social, and land-use assessments, moving the project into the formal evaluation phase with stakeholder engagement.

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  17 February 2026

  Novo Nordisk: EU Approves Higher Wegovy® Dose for Obesity, 21% Average Weight Loss

  The EU approved a 7.2 mg Wegovy® dose for obesity. In studies, participants lost 21% body weight on average. Common side effects: nausea, diarrhea, vomiting, and dysaesthesia.
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  17 February 2026

  FDA Approves Johnson & Johnson's Monthly EGFR Therapy RYBREVANT FASPRO

  FDA approves monthly dosing for RYBREVANT FASPRO, maintaining efficacy and reducing administration time and reactions compared to bi-weekly and IV schedules for EGFR-mutated NSCLC treatment.
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  17 February 2026

  Stahl Wins 2025 adiFORMULATOR Award from adidas

  Stahl's commitment to safer formulations and ZDHC compliance earns recognition, highlighting its role in advancing sustainable practices in the chemical industry.
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  17 February 2026

  Neste and World Fuel Services Expand SAF Availability at 100+ European Airports

  The five-year agreement supports regulatory compliance and boosts SAF supply, leveraging World Fuel's network and Neste's production capabilities.
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  16 February 2026

  Roche Reports Positive Phase III Results for Gazyva in Membranous Nephropathy

  Phase III study shows Gazyva achieves higher remission rates in membranous nephropathy, with safety consistent and no new signals. Data to be shared with health authorities.
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  15 February 2026

  Genentech's Gazyva Shows Positive Phase III Results in Primary Membranous Nephropathy

  Phase III study shows Gazyva achieves significant remission in primary membranous nephropathy, with safety profile consistent and no new signals. Data to be shared with health authorities.
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  13 February 2026

  EMA Recommends Withdrawal of Levamisole Medicines

  Levamisole's risks, including leukoencephalopathy, outweigh benefits for treating parasitic infections. EMA advises EU market withdrawal due to safety concerns.
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  12 February 2026

  European Industry Leaders Urge Action for Competitiveness and Sustainability

  EU industry leaders stress urgent reforms to prevent job losses and closures, advocating for regulatory changes and investment to balance green goals with competitiveness.
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  12 February 2026

  Stahl Achieves Early GIO Compliance for Food-Packaging Coatings

  Stahl's food-packaging coatings meet GIO standards early, enhancing sustainability and offering customers regulatory-ready solutions for future compliance.
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  11 February 2026

  Merck's KEYTRUDA and KEYTRUDA QLEX Approved for PD-L1+ Platinum-Resistant Ovarian Cancer

  FDA approves KEYTRUDA regimens for platinum-resistant ovarian cancer, showing reduced disease progression and death risk in trials.
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  11 February 2026

  ORLEN Acquires 25% Stake in Afrodite Gas Discovery

  ORLEN acquires 25% of PL293 in the North Sea, targeting 1.9 bcm of gas. The project tests new production methods and aligns with ORLEN's strategy for Norwegian gas development by 2030.
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  10 February 2026

  FDA Grants Priority Review to Takeda's Oveporexton for Narcolepsy Type 1

  Oveporexton, an orexin agonist, aims to treat narcolepsy type 1 by restoring orexin signaling. FDA's decision expected in Q3. Current treatments insufficient for many patients.
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  9 February 2026

  WuXi Biologics Earns Third Consecutive EcoVadis Platinum Medal

  Recognized for top ESG performance, the company strengthens sustainability with SBTi-approved targets, ISO 20400 certification, and green innovation initiatives.
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  9 February 2026

  Symrise Antitrust Investigation Closed by U.S. DoJ

  The U.S. DoJ found no unlawful practices. Symrise maintains its commitment to ethical business and anticipates similar outcomes in other investigations.
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  9 February 2026

  Novo Nordisk Sues Hims & Hers Over Unapproved Semaglutide Products

  Novo Nordisk seeks to stop Hims from selling unapproved semaglutide, citing patient safety risks and patent infringement.
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  7 February 2026

  Roche's Fenebrutinib Reduces Disability Progression in PPMS

  Fenebrutinib shows 12% risk reduction in disability progression vs. OCREVUS in PPMS, with potential benefits in upper limb function and plans for regulatory submission in 2026.
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  7 February 2026

  Genentech's Fenebrutinib Reduces Disability Progression in PPMS

  Fenebrutinib met its primary endpoint, showing a 12% reduction in disability progression risk in PPMS compared to Ocrevus, with potential benefits in upper limb function.
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  6 February 2026

  SkyNRG and MOB Finalize Environmental Permit for DSL-01

  Agreements on emission values led to design changes, reducing wastewater discharge and enhancing sustainability without court involvement.
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  6 February 2026

  BASF's Engenia Herbicide Approved by EPA

  EPA approves Engenia herbicide for dicamba-tolerant soybeans and cotton, offering farmers a tool against resistant weeds. BASF provides training for proper application.
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  6 February 2026

  Ercros Achieves ISO 42001:2023 AI Certification

  Ercros' AI management system is now ISO 42001:2023 certified, ensuring responsible, reliable, and transparent AI use with enhanced governance and risk management.
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  6 February 2026

  Hyliko Expands Renewable Hydrogen Supply with Lhyfe in Paris Region

  Hyliko secures a multi-year contract for over 200 tonnes of RFNBO hydrogen, supporting decarbonized transport and benefiting from the upcoming TIRUERT scheme.
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  5 February 2026

  Heidelberg Materials Acquires Maas Group's Construction Materials Business in Australia

  The acquisition includes 40 quarries, 22 concrete plants, and 2 asphalt sites, enhancing product offerings in Eastern Australia. Completion expected in the second half of 2026.
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  4 February 2026

  Novo Nordisk Launches Ozempic® Pill in US by Q2 2026

  FDA approves Ozempic® tablets for type 2 diabetes, offering enhanced bioavailability. Launch set for Q2 2026.
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  4 February 2026

  Lilly Q4 2025 Financial Results and 2026 Outlook

  Q4 revenue rose 43% to $19.3B, EPS up 51%. FDA approved Kwikpen, expanded Jaypirca use. 2026 revenue guidance: $80B-$83B, EPS: $33.50-$35.00.