Curated news and analysis on clinical trials, drug approvals, and medical research.
The FDA said one pivotal trial plus confirmatory evidence will become the default standard for approval of most new drugs. The shift could extend beyond rare diseases to common conditions affecting millions.
Krystal Biotech said IOLITE enrollment for KB803 is complete and it remains on track for KB803 and KB801 registrational data readouts in 2026. The company also reported FDA platform technology designations for KB407 and KB111 and continued VYJUVEK expansion.
European rare disease and healthcare policy conferences are scheduled for 2026 in Prague, Brussels and Cyprus. The meetings will address orphan products, European Reference Networks, cross-border healthcare, research collaboration and patient access to treatment.
A full-day conference on artificial intelligence in medicine will examine recent advances, clinical potential, and persistent challenges in translating innovation into meaningful health care impact.
Cynata raised $1.5 million through a placement at $0.25 a share ahead of Phase 3 osteoarthritis and Phase 2 aGvHD trial readouts due in May and June 2026. Its aGvHD study has completed the 100-day primary evaluation period for all 65 participants.
The radioligand therapeutics market in cancer treatment is estimated to grow from $2.6 billion in 2025 to $4.8 billion by 2030 at a 13.1% CAGR. Growth is supported by approved products Pluvicto and Lutathera and expanding use of PSMA and SSTR-targeted therapies.
Santana Minerals said the Bendigo-Ophir Gold Project has a 140 working-day fast-track approval timetable, with a decision due by 29 October 2026. The company also secured a NZ$115 million Komatsu fleet and said development consent is expected in H2 CY26.
Research in the United Kingdom found that preventing type 2 diabetes cut care-related greenhouse gas emissions by about 67%, while well-controlled disease was linked to 21% lower emissions than uncontrolled diabetes.
More cancer survivors are living long enough to face lasting cardiovascular effects of treatment. Cardio-oncology clinics are managing heart failure, valvular disease and radiation-related heart disease.
Ruxolitinib remains the standard frontline therapy for intermediate-2 and high-risk myelofibrosis, with phase 3 and real-world data showing spleen and symptom benefits. Cytopenias, transfusion needs and resistance after 2 to 3 years continue to drive interest in new combinations.
A review in Endocrine Reviews said explicit guidance on medication timing can improve hormonal therapy efficacy and quality of life. It outlined chronotherapy recommendations across endocrinology treatments.
Olema Pharmaceuticals appointed Prakash Raman, Ph.D., to its board of directors. The company said the oncology deal veteran joins as Olema advances palazestrant and OP-3136 while remaining loss-making.
Arcutis is in focus after new Phase 3 extension data for Zoryve cream 0.05% in young children with atopic dermatitis and ahead of its Feb. 25 Q4 results. Investors are also watching recent FDA actions and pipeline updates for additional pediatric and dermatology indications.
Volume 37 of SLAS Technology features an AI drug discovery framework, a pipelining Bayesian optimization method, and a field-deployable virus detection platform.
C-peptide is described as a key biomarker for beta cell function in type 1 diabetes and a potential surrogate endpoint for drug approval. Current trial endpoints remain difficult for disease-modifying therapies.
ByteDance is expanding its AI drug-discovery work through Anew Labs and US hiring for its Seed AI team. Anew Labs has presented AI-developed therapies and molecular modeling work at international conferences.
mRNA medicine and spatiotemporal drug delivery systems are expanding options for cardiovascular disease. The sources describe preclinical proof-of-concept, clinical trials and programmable cardiac repair platforms.
A Pennsylvania jury ordered Johnson & Johnson to pay $250,000 to the family of Gayle Emerson in a talc baby powder ovarian cancer case. The verdict comes amid more than 90,000 talc lawsuits and ongoing fights over expert testimony.
Vanguard increased its Moderna stake by 1.0% in the fourth quarter to 41.6 million shares worth $1.23 billion. Other institutional investors also adjusted positions, while 75.33% of the stock is held by institutions and hedge funds.
A federal judge froze appointments to the CDC’s ACIP, halted its votes, and paused recent HHS vaccine policy changes. The ruling leaves several FDA-approved vaccines pending review.
