Pharmaceutical News
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FDA Accepts Takeda’s ENTYVIO sBLA for Pediatric IBD
Takeda’s supplemental Biologics License Application for intravenous ENTYVIO® (vedolizumab) has been accepted by the FDA for pediatric patients aged 2 and older with moderately to severely active ulcerative colitis and Crohn’s disease. Approval could provide a vital gut-focused treatment for children, addressing a significant unmet medical need. Read more
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Sanofi Stops Phase 3 Riliprubart Study in Refractory chronic inflammatory demyelinating polyneuropathy
Sanofi has decided to discontinue the Phase 3 MOBILIZE study of riliprubart in patients with treatment-refractory chronic inflammatory demyelinating polyneuropathy (CIDP) after an interim analysis showed insufficient efficacy. No new safety concerns were raised. The company will evaluate the implications for other riliprubart studies while ensuring proper care for enrolled participants. Read more
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FDA Approves Lilly’s EBGLYSS (Lebrikizumab) for Every-8-Week Dosing
The FDA approved a new maintenance regimen for EBGLYSS (lebrikizumab-lbkz), allowing eligible patients with moderate-to-severe atopic dermatitis to receive a single 250 mg injection every eight weeks. This regimen reduces treatment burden, entails six annual injections, and maintains effective disease control without requiring initial topical therapies. Read more
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FDA Approves Europe’s Bemotrizinol for U.S. Sunscreens
The FDA has approved bemotrizinol as a new active ingredient for over-the-counter sunscreen products, the first addition since the late 1990s. It offers broad-spectrum UVA and UVB protection while being generally recognized as safe for use in adults and children over six months. This decision promotes innovation in sunscreen options for U.S. consumers. Read more
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Sanofi’s Sarclisa SC Wins EU Approval for At-Home Delivery
Sanofi’s Sarclisa (isatuximab) has received European Commission approval for a subcutaneous formulation, the first of its kind for cancer therapy in the EU. This formulation can be administered via an on-body injector or manual injection, enhancing patient convenience and satisfaction while maintaining efficacy and safety, as shown in the Phase 3 IRAKLIA study. Read more
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GSK to Acquire Nuvalent for $10.6 Billion to Expand Lung Cancer Portfolio
GSK announced its agreement to acquire Nuvalent for approximately $10.6 billion, enhancing its lung cancer treatment pipeline with three key assets. This includes two promising therapies, zidesamtinib and neladalkib, currently under FDA review. The acquisition aligns with GSK’s strategy to improve cancer treatment efficacy and is expected to boost revenues by 2027. Read more
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Pfizer Highlights Pipeline Momentum Across Obesity, Hemophilia, and Investor Outreach
In June 2026, Pfizer updated stakeholders on its obesity pipeline and hemophilia franchise, emphasizing late-stage clinical advancements. Notable highlights included positive Phase 2b results for berobenatide, showcasing significant weight loss, and FDA approval of HYMPAVZI for younger hemophilia patients. The company’s strategy focuses on growth in these therapeutic areas. Read more
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Novartis to Showcase Rhapsido Data at EAACI 2026
Novartis will present data on 10 abstracts at the EAACI Congress 2026, focusing on its investigational BTK inhibitor, Rhapsido® (remibrutinib). Highlights include findings from the Phase III RemIND and REMIXED studies on chronic urticaria, as well as Phase II data on peanut allergy. Presentations aim to enhance understanding of BTK inhibition in immune-mediated diseases. Read more
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Roche, Nurix Partner on BTK Degrader Bexobrutideg
Roche has partnered with Nurix Therapeutics to co-develop bexobrutideg (NX-5948), an investigational BTK degrader for hematology, immunology, and neurology. The agreement includes $700 million upfront and potential total payments up to $2.3 billion. A Phase 3 trial for chronic lymphocytic leukemia is scheduled to start in summer 2026. Read more
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Moderna, Oxford Win UK Clearance for Lynch Syndrome Vaccine Trial
Moderna and the University of Oxford have received UK regulatory approval for a Phase 1/2 clinical trial of mRNA-4194, a cancer vaccine targeting Lynch syndrome. This landmark study aims to utilize mRNA technology for cancer prevention, assessing safety and immune response, with the first participant expected to be dosed in summer 2026. Read more
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Lilly’s Foundayo Outperforms Oral Semaglutide in Phase 3 Diabetes Trials
Eli Lilly’s Phase 3 ACHIEVE studies demonstrated that its oral GLP-1 receptor agonist, Foundayo, significantly improves glycemic control and weight loss in adults with type 2 diabetes compared to oral semaglutide and dapagliflozin. Findings included A1C reductions up to 2.2% and weight loss up to 19.7 pounds, with a regulatory submission planned by mid-2026. Read more
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SLEEP 2026: Jazz Pharmaceuticals to Showcase 21 Xywav Abstracts
Jazz Pharmaceuticals will present 21 abstracts, including 11 late-breaking ones, at SLEEP 2026, focusing on Xywav’s effects on narcolepsy and idiopathic hypersomnia. The presentations will cover treatment experiences, quality of life, and clinical outcomes, showcasing research from the DUET and LYRICAL studies, emphasizing the significance of low-sodium oxybate therapy. Read more