Curated news and analysis on clinical trials, drug approvals, and medical research.
The Middle East and Africa biosimilars market is estimated to grow from USD 1.15 billion to USD 5.73 billion by 2035 at a 19% CAGR. Monoclonal antibodies hold almost 55% of market share, while oncological disorders dominate demand.
The FDA extended by three months the review period for Savara's MOLBREEVI biologics license application in autoimmune pulmonary alveolar proteinosis, moving the PDUFA date to Nov. 22, 2026. Savara had previously said the FDA filed the application after a resubmission tied to manufacturing data and a transfer to Fujifilm.
Spyre Therapeutics announced ECCO 2026 presentations featuring 20-week follow-up from the Phase 1 SPY003 study and details of the SKYLINE-UC platform study. The company is also seeking to raise $403 million in a follow-on stock offering.
Europe's infusion pump market is projected to reach USD 7.09 billion by 2031 at a 6.8% CAGR. Growth is driven by connected systems, tighter safety standards, homecare use, and diabetes demand.
Early results from stage I of the phase 3 PRESERVE-003 trial showed gotistobart improved overall survival versus docetaxel in previously treated metastatic squamous NSCLC. Objective response rate and duration of response also favored gotistobart, while progression-free survival did not differ significantly.
The U.S. Department of Energy revised its reactor authorization process to speed advanced reactor review and construction. The pathway cuts 17 steps to 11 and removes more than 900 pages from prior guidance.
Needle-free allergy therapy is forecast to expand through 2035 as self-administered options gain share. House dust mite allergy treatment is projected to grow from $3.18 billion in 2025 to $8.75 billion by 2033.
Algorithmiq, Cleveland Clinic and IBM earned the $2 million Q4Bio prize after using quantum computing to simulate key processes in photodynamic therapy. The Wellcome Leap program launched with $40 million in funding, and five of six Phase III finalists used IBM quantum hardware.
Mesoblast received FDA clearance for a registrational DMD trial of remestemcel-L-rknd, while Satellos began dosing boys in the Phase 2 BASECAMP study of SAT-3247. The studies are enrolling children ages 5-9 and 7-9, respectively.
The FDA approved once-monthly subcutaneous amivantamab with lazertinib for first-line EGFR-mutated advanced NSCLC. PALOMA-2 showed high response rates and no new safety signals.
A major evidence review of 17 clinical trials involving more than 20,000 participants found anti-amyloid Alzheimer’s drugs had absent or trivial effects on cognitive decline and dementia. The review also said the drugs likely increase the risk of brain swelling and bleeding.
A study in The Lancet Child & Adolescent Health linked academic pressure at age 15 to higher depressive symptoms through age 22 and self-harm risk through age 24.
A new Cochrane review said anti-amyloid Alzheimer’s drugs show no clinically meaningful benefit, but many researchers said the analysis has major limitations. Newer evidence on lecanemab and donanemab and broader drug development efforts continue to shape the field.
A review of 17 studies involving 20,342 patients found anti-amyloid Alzheimer’s drugs had “trivial” effects after 18 months and increased the risk of brain swelling and bleeding. A separate PET study suggested ARIA-E may mark brain regions with greater amyloid plaque reduction.
Novartis chief executive Vas Narasimhan has joined Anthropic’s board. The appointment adds a pharma executive as Anthropic expands into drug discovery and launches Claude for Life Sciences.
Lunai Bioworks said it received U.S. Patent No. 12,369,861 for debiasing data in drug discovery predictions. The patent covers multimodal data standardization and structural bias removal before predictive modeling.
Louisiana regulators voted to fast-track Entergy’s $21 billion proposal tied to Meta’s planned Richland Parish data center. Analyses cited in the debate say the policy could shift more than half of related power costs to ratepayers and add $14 billion to $26 billion in wholesale electricity system costs over 15 years.
The University of Cincinnati Cancer Center’s Blood Cancer Healing Center added research laboratories and the UC Osher Wellness Suite and Learning Kitchen. The expansion joins clinical services launched in July 2024 and adds new research, wellness and community programming space.
A perspective article says global regulatory frameworks for generative AI medical devices are an urgent priority. It highlights risks, limits of current rules, and the need for multidisciplinary collaboration.
Studies in muscle-invasive bladder cancer found ctDNA predicted metastatic risk after bladder-sparing treatment, while urine tumor DNA was more sensitive for residual bladder disease. Data from RETAIN-2 and a PNAS study support molecular testing to help select patients for bladder preservation.
