Regulatory and Compliance Updates news (page 6)

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  9 March 2026

  Sinopec Leads Hydrogen Standardization in Energy Industry

  A new committee aims to enhance hydrogen industry standards, drive innovation, and regulate the market, marking a key step for China's hydrogen energy sector.
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  9 March 2026

  GSK and Alfasigma License Agreement for Linerixibat Rights

  Alfasigma gains global rights to develop and market linerixibat for cholestatic pruritus in PBC. GSK to receive payments and royalties. Regulatory reviews are ongoing.
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  8 March 2026

  Genentech Updates on Phase III persevERA Study in ER-Positive Breast Cancer

  persevERA study showed no significant progression-free survival improvement, but giredestrant was well tolerated. Further studies planned with CDK4/6 inhibitors.
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  6 March 2026

  TotalEnergies Releases Independent Review of Tilenga Project Land Acquisition in Uganda

  The assessment confirms compliance with land acquisition standards. An action plan addresses livelihood restoration, support for vulnerable households, grievance management, and gender considerations.
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  6 March 2026

  Genentech's Gazyva Reduces Lupus Disease Activity in Phase III Trial

  Gazyva shows significant improvement in SLE symptoms, achieving a 76.7% response rate and doubling remission rates in a Phase III trial, as published in NEJM.
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  5 March 2026

  Johnson & Johnson's TECVAYLI and DARZALEX FASPRO Approved by FDA for Relapsed Multiple Myeloma

  FDA approves TECVAYLI plus DARZALEX FASPRO for relapsed multiple myeloma, offering a new treatment option as early as second line with improved safety and efficacy.

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  4 March 2026

  MOL and Slovnaft File Complaint Against JANAF for Monopoly Abuse

  JANAF delays crude oil supply, citing legal checks, despite EU sanctions compliance, causing supply issues for Central Europe. MOL seeks EU intervention for fair access and pricing.
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  4 March 2026

  Sinopec Backs New National Greenhouse Gas Emission Database

  The updated database includes methane emission factors for onshore facilities, aiding accurate greenhouse gas calculations and supporting emission reduction efforts in the oil and gas sector.
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  3 March 2026

  Johnson & Johnson's Nipocalimab Gets FDA Fast Track for Lupus Treatment

  Nipocalimab, an investigational therapy, aims to address unmet needs in lupus by reducing harmful IgG while preserving immune function, following positive Phase 2b results.
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  2 March 2026

  Takeda's Rusfertide Receives FDA Priority Review

  Rusfertide shows promise in controlling hematocrit and reducing symptoms in polycythemia vera, with FDA review based on positive Phase 3 and long-term study data.
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  1 March 2026

  Genentech's Fenebrutinib Shows Promise as BTK Inhibitor for MS in Phase III Study

  Fenebrutinib reduced relapses by 51% in RMS, consistent with prior studies. Data will be submitted to regulators. Safety profile comparable to teriflunomide; further analysis on fatalities ongoing.
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  28 February 2026

  Merck's KEYTRUDA and WELIREG Combo Reduces RCC Recurrence Risk by 28%

  Phase 3 trial shows KEYTRUDA and WELIREG improve disease-free survival in RCC. FDA accepts priority review for adjuvant treatment. Safety profile consistent with previous studies.
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  28 February 2026

  Merck and Eisai: WELIREG and LENVIMA Reduce Disease Progression Risk by 30% in Advanced RCC Trial

  Phase 3 trial shows WELIREG plus LENVIMA improves progression-free survival in advanced RCC, with FDA reviewing new drug applications.
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  27 February 2026

  FDA Approves Novo Nordisk's Sogroya for New Pediatric Uses

  Sogroya, a once-weekly growth hormone, is now approved for children with ISS, SGA, or NS, offering an alternative to daily injections and expanding treatment options.
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  27 February 2026

  Merck's KEYTRUDA Plus Paclitaxel Boosts Survival in Platinum-Resistant Ovarian Cancer

  KEYTRUDA plus paclitaxel improves overall survival in platinum-resistant ovarian cancer, regardless of PD-L1 status, as shown in the KEYNOTE-B96 trial.
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  27 February 2026

  Lilly's Olumiant Gains CHMP Nod for Adolescent Alopecia Areata in EU

  CHMP backs Olumiant for severe alopecia areata in adolescents, based on Phase 3 study showing 42% achieved 80% scalp hair coverage at 36 weeks. Awaiting European Commission decision.
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  26 February 2026

  GSK's Bepirovirsen Under Review in Japan for Chronic Hepatitis B Treatment

  Japan reviews bepirovirsen for chronic hepatitis B. Phase III trials show higher functional cure rates and acceptable safety. SENKU designation granted for expedited review.
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  26 February 2026

  GSK's Linerixibat Gets Priority Review in China for PBC-Related Itch

  Linerixibat shows significant improvement in cholestatic pruritus in PBC patients, based on GLISTEN phase III trial data. Regulatory reviews ongoing in US, EU, UK, and Canada.
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  26 February 2026

  MOL Accuses JANAF of Legal Violations Over Russian Oil Transit

  MOL demands JANAF allow unsanctioned Russian oil via sea, citing EU/US rules. Non-compliance may lead to legal action and claims for damages.
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  26 February 2026

  FDA Approves Boehringer Ingelheim's HERNEXEOS for HER2-Mutant NSCLC

  HERNEXEOS gains FDA approval for HER2-mutant NSCLC, showing a 76% response rate in trials. Further confirmation required for continued approval.
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  26 February 2026

  BASF Introduces Biomass Balance Autofroth Foam for North American Market

  BMB Autofroth foam cuts carbon emissions by 18-20%, offers a drop-in solution for sustainability without process changes, and suits various applications.
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  26 February 2026

  Lilly's Orforglipron Outperforms Semaglutide in Diabetes Trial

  Orforglipron 36 mg reduced A1C by 2.2% and weight by 9.2%, surpassing semaglutide in a 52-week trial with 1,698 participants. Results published in The Lancet.
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  25 February 2026

  Merck Animal Health's NUMELVI: FDA-Approved JAK Inhibitor for Canine Allergic Dermatitis

  FDA approves NUMELVI for dogs 6+ months, a JAK inhibitor for allergic dermatitis, offering rapid itch relief and easy dosing. Available spring 2026.
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  25 February 2026

  Merck Presents Phase 3 Trial Results for HIV-1 Treatment DOR/ISL at CROI 2026

  DOR/ISL shows non-inferiority and similar safety to BIC/FTC/TAF in HIV-1 treatment-naïve adults and maintains suppression in those switching from other therapies.
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  25 February 2026

  MOL and Janaf Agree on Adria Pipeline Capacity Tests

  Long-term tests will assess Adria pipeline capacity. MOL seeks clarity on Russian oil shipments and criticizes Janaf's pricing. Two competitive routes are vital for regional supply security.
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  25 February 2026

  Regulation Essential for OCCS Investment in Maritime Decarbonization

  A DNV report highlights the need for clear regulations to advance OCCS technology, crucial for maritime decarbonization, with pilot projects showing technical feasibility and economic potential.
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  25 February 2026

  Clariant Gains EU Approval for Rice Bran Wax in Food-Contact Plastics

  EU approval allows rice bran wax additives in PET, PLA, and PVC for food-contact, offering a sustainable alternative to montan wax with lower carbon footprint and supply chain benefits.
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  24 February 2026

  Johnson & Johnson Seeks FDA Approval for IMAAVY® to Treat wAIHA

  IMAAVY® targets wAIHA by blocking FcRn, reducing IgG. Phase 2/3 study shows improved hemoglobin and fatigue.
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  24 February 2026

  Rompetrol Rafinare Schedules Turnaround for Petromidia and Vega Refineries

  Petromidia and Vega refineries will halt operations for a 20-day scheduled maintenance, focusing on inspections, equipment cleaning, and component replacements to ensure safety and efficiency.
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  23 February 2026

  Johnson & Johnson's RYBREVANT® Approved for New Dosing Options in EGFR-Mutated Lung Cancer

  European Commission approves subcutaneous RYBREVANT® for flexible dosing in advanced EGFR-mutated NSCLC, offering reduced clinic time and fewer reactions.