Regulatory and Compliance Updates news (page 2)

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  12 June 2026

  Merck: FDA approves KEYTRUDA and KEYTRUDA QLEX with WELIREG for adjuvant ccRCC

  FDA cleared PD‑1 plus HIF‑2α adjuvant regimens after Phase 3 showed 28% lower recurrence risk and 81% vs 74% 24‑month DFS; notable anemia, hypoxia and treatment discontinuations.
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  12 June 2026

  BASF’s Tinosorb S (bemotrizinol) approved by FDA as first new U.S. sunscreen active in 27 years

  FDA clears bemotrizinol, a broad‑spectrum, photostable UV filter that enables longer‑lasting, stronger UVA/UVB protection and improved formulation stability.
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  12 June 2026

  Chugai files Tecentriq for maintenance therapy after definitive chemoradiotherapy in locally advanced esophageal cancer

  Submission seeks approval of an anti‑PD‑L1 agent as maintenance therapy after definitive chemoradiotherapy, supported by SKYSCRAPER‑07 Phase III interim results.
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  12 June 2026

  GSK’s momelotinib gains orphan drug status in US and EU for VEXAS

  Orphan designations back development of momelotinib for VEXAS; ATLAS phase II/III underway with design to be shown at EHA 2026.
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  11 June 2026

  Novo Nordisk: Wegovy pill approved in UK as first daily GLP-1 weight-loss tablet in Europe

  Daily 25 mg semaglutide tablet approved as adjunct to diet and exercise for adults with obesity or overweight plus a weight‑related condition; private prescriptions expected soon.
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  11 June 2026

  Johnson & Johnson’s IMAAVY shows rapid, durable hemoglobin gains in Phase 2/3 wAIHA trial

  Nipocalimab 30 mg/kg produced rapid hemoglobin rises and ~3× more durable responders versus placebo at 24 weeks, with early fatigue improvement and reduced steroid use.

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  11 June 2026

  Takeda's zasocitinib outperforms deucravacitinib in Phase 3 psoriasis head-to-head

  Once-daily oral TYK2 inhibitor showed statistical superiority to deucravacitinib for PASI100 and key secondary endpoints, with >35% achieving complete skin clearance at week 16.
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  11 June 2026

  European Commission secures stronger MSR safeguards for ETS2 (buildings & road transport)

  Strengthened MSR for ETS2 doubles allowance injections, extends reserve validity past 2030, enables earlier gradual releases, and starts early auctions in 2027 with a €3bn frontloading facility.
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  11 June 2026

  Evonik launches low‑carbon peracetic acid for Europe

  Peracetic acid produced using bio-based acetic acid and low‑carbon hydrogen peroxide; mass‑balance accounting lets customers lower Scope 3 emissions transparently.
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  10 June 2026

  Genentech: FDA grants Priority Review for Tecentriq plus chemotherapy in stage III dMMR/MSI‑H colon cancer

  FDA accepted an sBLA for adjuvant PD‑L1 therapy plus chemotherapy in stage III dMMR/MSI‑H colon cancer; agency decision expected Oct 9, 2026.
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  10 June 2026

  Aptar N‑Sorb patent allowed by USPTO for packaging-based nitrosamine mitigation

  USPTO allowed a patent for N‑Sorb, a packaging material that reduces nitrosamines across multiple APIs and may support FDA Orange Book strategies.
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  10 June 2026

  dsm-firmenich: FDA approves bemotrizinol (PARSOL® Shield) for U.S. suncare

  FDA clears bemotrizinol (PARSOL® Shield), the first new U.S. sunscreen active in 25+ years, enabling broad‑spectrum, photostable formulas with low‑concentration efficacy.
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  9 June 2026

  Moeve 2025 Environmental Statement for La Rábida and Palos

  Annual report shows €33.8m+ invested in environmental upgrades, 100% renewable power in 2025, major waste recovery and water-use cuts, plus EU funding for green hydrogen project.
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  9 June 2026

  Lilly gains FDA approval for EBGLYSS every‑eight‑week maintenance dosing

  New every‑eight‑week maintenance option offers as few as six injections per year and can be used without mandatory topical therapy from treatment start.
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  9 June 2026

  Takeda: FDA accepts sBLA for IV ENTYVIO in pediatric UC and Crohn’s

  FDA accepted an sBLA to extend IV vedolizumab (ENTYVIO) to children aged 2+ with moderately to severely active UC and Crohn’s; PDUFA Q1 2027.
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  9 June 2026

  PureCycle & Innovia Films produce white, cavitated BOPP using PureFive Choice™ recycled PP

  White, cavitated BOPP film made with >40% post‑consumer recycled polypropylene showed virgin‑like processing and comparable mechanical, barrier and sealing performance.
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  9 June 2026

  GSK to acquire Nuvalent for $10.6 billion

  Includes two late-stage ROS1 and ALK NSCLC inhibitors under FDA review for 2026 decisions, plus a HER2 candidate; expected to be accretive to profit from 2027 and funded by debt and cash.
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  8 June 2026

  Honeywell expands OT Cybersecurity Suite with AI monitoring and secure media controls

  Adds five OT security capabilities — AI monitoring, secure media scanning, data diode, Cyber GRC automation and a managed OT SOC — for manufacturing, energy and critical infrastructure.
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  8 June 2026

  Lilly's Foundayo (orforglipron) outperforms oral semaglutide, dapagliflozin and placebo in ACHIEVE trials

  Oral GLP‑1 orforglipron reduced A1C and body weight more than oral semaglutide, dapagliflozin or placebo across three Phase‑3 trials; FDA filing planned by end of Q2 2026.
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  8 June 2026

  Gilead and Merck: Phase 3 ISLEND trials show positive topline results for once‑weekly islatravir/lenacapavir

  Once‑weekly oral islatravir 2 mg/lenacapavir 300 mg met Week 48 primary endpoint, non‑inferior to Biktarvy and daily standard‑of‑care; safety profile comparable across arms.
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  8 June 2026

  Merck and Gilead discontinue Phase 3 KEYNOTE‑D46/EVOKE‑03 (Trodelvy + KEYTRUDA) in PD‑L1 ≥50% mNSCLC

  eDMC recommended stopping the Phase 3 trial after final PFS and interim OS reviews: PFS trend non‑significant, OS unlikely to be significant; safety profile consistent; ~620 patients enrolled.
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  8 June 2026

  Meccanoplastica showcases INEOS recycled HDPE at PLAST 2026

  Live blow-moulding demo will produce 200ml cosmetic bottles with advanced recycled HDPE; 4L samples use Recycl-IN HDPE with 50% post‑consumer recyclate to support regulatory targets.
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  7 June 2026

  Boehringer Ingelheim: Survodutide Phase III shows up to 34% visceral and 63% liver fat reduction with limited lean mass loss

  Phase III data show targeted visceral and liver fat reductions with minimal lean mass loss and sustained weight loss in obesity and MASLD populations.
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  7 June 2026

  Novo Nordisk CagriSema Phase 3 trials show large HbA1c and weight reductions

  Once‑weekly cagrilintide+semaglutide reduced HbA1c by up to 2.33 percentage points and bodyweight by up to 14.2% across REIMAGINE 1–3 versus comparators.
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  7 June 2026

  Amgen: Repatha (evolocumab) cuts first major CV events 29% in high‑risk diabetes subgroup

  VESALIUS‑CV subgroup shows evolocumab lowers first major cardiovascular events and LDL‑C; real‑world GLP‑1 persistence is low, curbing potential benefits.
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  6 June 2026

  MOL secures OFAC licence to continue NIS acquisition talks

  US licence allows continuation of talks to buy a majority stake in a Serbian oil company until 16 June 2026, enabling finalisation of transaction documentation.
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  5 June 2026

  Clariant launches Exolit AP 422 A — SVHC‑free ammonium polyphosphate

  New non‑halogenated APP for intumescent coatings, firestop seals and PIR insulation; contains <0.1% melamine to meet REACH SVHC criteria.
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  4 June 2026

  BASF launches InVigor Gold L322 canola hybrid for 2027 (Montana)

  Early‑maturing Brassica juncea hybrid for warmer, drier, low‑organic soils; offers native pod‑shatter tolerance and LibertyLink weed control; availability in Montana pending approvals.
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  4 June 2026

  Caleyda: food‑grade approval process begins

  EFRO-funded plesTic Ready backs an exploration of food-grade certification for mixed-culture PHA from organic residual streams with value‑chain partners.
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  3 June 2026

  MAIRE awarded Industry Mover in S&P Global Sustainability Yearbook 2026

  Recognised for the largest year-on-year ESG improvement in its sector; 2025 gains include a 6% cut to Scope 1–2 emissions, 1.2 Mt CO2 avoided and 90,000 m³ of water reused.