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Jul 25, 2026
A real-world study in Galicia showed nirsevimab reduced RSV-related hospitalizations by 85.9% in the first season and 55.3% in the second. The RSV prevention market is expanding to cover high-risk children, with Beyfortus the only antibody approved for second-season use. The FDA has cited Sanofi for misleading promotional claims about the product.
Jul 14, 2026
Acurx Pharmaceuticals announced that ibezapolstat preserves beneficial gut microbes in multiply-recurrent C. difficile infection and outperforms standard antibiotics in biofilm killing. A pilot trial in rCDI is set to begin, with plans for FDA approval under the Limited Population Pathway if successful.
Jun 27, 2026
ACADIA Pharmaceuticals' stock jumped after the European Medicines Agency recommended approval of its Rett syndrome drug Daybue. The company also reported strong quarterly results and progress on its Alzheimer's disease psychosis treatment.
Jun 22, 2026
Regeneron announced FDA and EMA review acceptance for cemdisiran in generalized myasthenia gravis and FDA priority review acceptance for garetosmab in fibrodysplasia ossificans progressiva. The garetosmab BLA is supported by Phase 3 OPTIMA trial data showing 94% and 90% reductions in new bone lesions.
Jun 16, 2026
Acurx Pharmaceuticals is advancing ibezapolstat to international Phase 3 clinical trials for C. difficile infection following final regulatory guidance from FDA and EMA. The company launched a new clinical trial program for recurrent CDI and presented structural biology research demonstrating ibezapolstat's mechanism of action. Acurx reported year-end 2025 cash of $7.6 million.
Jun 10, 2026
The U.S. cardiovascular drugs market is projected to reach $37.03 billion by 2035, growing at a CAGR of 2.68%. Europe's anticoagulants market is expected to reach $23.68 billion by 2033, expanding at a CAGR of 8.22%.
Jun 09, 2026
AI-driven feasibility tools are cutting clinical trial site selection timelines from months to weeks by analysing historical data, enrolment benchmarks, and geographic trends. Clinical trial pharmacy software platforms are integrating with management systems and incorporating AI, machine learning, and blockchain to improve medication tracking, regulatory compliance, and data security across global trials.
Jun 09, 2026
Updated data from the phase I CaMMouflage trial showed CB-011, the first allogeneic anti-BCMA CAR-T therapy with immune cloaking, achieved an approximately 92% overall response rate in relapsed/refractory multiple myeloma. The 2026 Tandem Meetings also highlighted advances in EB-103, KITE-753, and LV20.19 CAR-T constructs across lymphoma and CLL. Separately, NXC-201 reported a 95% complete response rate in AL amyloidosis.
Jun 08, 2026
Sangamo Therapeutics has retained Raymond James to evaluate strategic alternatives to advance its pipeline and maximize stakeholder value. Key assets include the BLA-ready Fabry disease gene therapy ST-920, the STAC-BBB capsid platform generating $88M in fees to date, and multiple neurology programs. No transaction has been agreed and no timetable has been set.
Jun 05, 2026
Servier will acquire Edgewise Therapeutics' muscular dystrophy business, including the drug sevasemten, for up to $2.65 billion. Sevasemten recently faced an FDA rejection for accelerated approval in Becker muscular dystrophy but is advancing to a Phase 3 trial in 2026. The drug has received multiple FDA and EMA designations for both Becker and Duchenne muscular dystrophy.
Jun 03, 2026
Quantitative and functional MRI techniques are gaining traction as biomarkers in neurodegenerative diseases. A consensus statement provides MRI endpoint recommendations for clinical trials in hereditary ataxias like SCA and Friedreich ataxia. Separately, research shows resting-state fMRI can distinguish subtypes of multiple system atrophy and may improve early diagnosis.
Jun 01, 2026
The FDA has approved Shionogi's XOCOVA (ensitrelvir) as the first oral antiviral for post-exposure prophylaxis of COVID-19. Approval was based on the Phase 3 SCORPIO-PEP trial, which showed a 67% reduction in risk of symptomatic disease after exposure.
May 22, 2026
A comparative study found Canadian patients waited more than 90 weeks longer than Americans and 65 weeks longer than Europeans for new drugs approved between 2019 and 2025. The report said late submissions to Health Canada, along with price controls and other market factors, were the main drivers.
May 20, 2026
Research and Markets added two cell and gene therapy publications, including a tools and reagents market report forecasting growth from $12 billion in 2025 to $19.8 billion by 2030. The reports track approvals, financing, deals, and manufacturing developments.
May 20, 2026
Cinclus Pharma said its first Phase III study is nearing full enrollment, with topline results expected in the fourth quarter of 2026. The company also reported regulatory progress for linaprazan glurate and a EUR 28 million financing agreement.
May 17, 2026
4D Molecular Therapeutics said 4D-150 is in Phase 3 for wet AMD and nearing Phase 3 in diabetic macular edema. The company reported rapid enrollment, 18-month treatment burden reductions and favorable safety data.
May 17, 2026
ImmunityBio said the Saudi FDA encouraged submission of a regulatory package for recombinant BCG and opened talks on expanding ANKTIVA with checkpoint inhibitors to additional tumor types. The company expects to file the rBCG package within weeks.
May 15, 2026
Only 17.7% of pediatric anticancer drugs advance to phase 3 trials, and just 12% earn FDA approval within 10 years, compared to 38.7% for adult drugs. The pace of pediatric approvals has accelerated recently, but funding and market size constraints remain.
May 14, 2026
U.S. insulin glargine and biosimilar developments in 2026 included CivicaScript's low-cost launch and California's CalRx rollout. The global insulin biosimilars market reached US$2.5 billion in 2025 and is projected to reach US$6.0 billion by 2033.
May 13, 2026
Tumour-infiltrating lymphocyte therapy has shown durable responses in refractory melanoma, including a 31.4% objective response rate in phase II data. The 2024 FDA approval of Lifileucel marked a milestone as regulators in other markets continue reviews.
