Curated news and analysis on clinical trials, drug approvals, and medical research.
Novartis introduced new long-term social impact and sustainability targets covering access, global health, emissions, waste and water. The plan includes a 2030 access goal and net-zero across the value chain by 2040.
Operation Stork Speed aims to update U.S. infant formula standards. An FDA report due this spring is expected to review contaminants, ingredients and new safety protocols.
Healthcare AI companies are making bold claims, but many have not brought treatments to market. One article said human testing remains the key measure, citing trial timelines, costs, and current programs.
FDA approval of daratumumab for high-risk smoldering multiple myeloma marks a shift from observation to early intervention. In a Phase II trial in earlier-stage disease, the overall response rate was 54% and the primary endpoint was not met.
Novartis finalized a seventh new US facility as part of a $23 billion expansion. The new API site in Morrisville, North Carolina, supports end-to-end US manufacturing across multiple therapy platforms.
The United Arab Emirates has unveiled two gene therapy projects targeting autism, epilepsy, and rare brain disorders in children. The initiatives focus on underlying genetic causes and earlier diagnosis.
Amylyx is approaching key catalysts ahead of its May 7 earnings report, led by Phase 3 LUCIDITY data for avexitide in post-bariatric hypoglycemia due in the third quarter. The company is also expected to provide updates on AMX0035 in Wolfram syndrome and AMX0114 biomarker data in ALS.
CVRx announced first-patient enrollment in the BENEFIT-HF trial, a 2,500-patient heart failure study across about 150 U.S. and German centers. The trial will evaluate all-cause mortality and heart failure decompensation events through 2032.
Risankizumab data in Crohn’s disease showed 55% clinical remission at week 12 in AFFIRM, durable efficacy through 148 weeks in SEQUENCE, and the lowest 24-month switch rate in a U.S. claims analysis.
Topline phase 3 VIKTORIA-1 results showed gedatolisib combinations improved progression-free survival versus alpelisib plus fulvestrant in PIK3CA-mutant HR-positive/HER2-negative advanced breast cancer. Celcuity plans a supplemental FDA filing based on the data.
Alnylam reported full-year 2025 profitability and $2.987 billion in global net product revenues, driven by U.S. approval and growth of AMVUTTRA. The company also outlined 2026 pipeline goals and additional HELIOS-B analyses for vutrisiran.
The global antibody drug conjugate market is calculated at USD 14.76 billion in 2026 and is expected to reach USD 32.66 billion by 2035. North America held a 53% share in 2025, while Asia Pacific is projected to grow fastest.
ORIC selected rinzimetostat 400 mg plus darolutamide for the Himalayas-1 Phase 3 trial in post-abiraterone mCRPC, expected to start in 1H 2026. The company reported early efficacy and safety data and said cash runway extends into 2H 2028.
BioMarin reported first-quarter 2026 revenue of $766 million and raised full-year guidance to $3.825 billion-$3.925 billion. The company highlighted FDA approval of PALYNZIQ for adolescents and upcoming Phase 3 readouts for BMN 401 and VOXZOGO.
Vertex completed the rolling BLA submission for povetacicept in IgA nephropathy after positive Phase 3 RAINIER interim data. The company plans to use a Priority Review Voucher to accelerate FDA review.
Bassett Healthcare Network appointed Tiffany Otto as Division Chief of Dental Services, Anthony Ferrara as Associate Chief of Surgery, and Timothy Chapman as Chief of Pathology. The roles are tied to the network’s 2026-2028 strategic plan.
Two studies of older adults with type 2 diabetes linked diabetic retinal disease with higher dementia risk. DME and more severe diabetic retinopathy were associated with higher all-cause and vascular dementia risk, but not consistently with Alzheimer’s disease.
AbbVie raised 2026 revenue and EPS guidance after first-quarter results beat estimates, with Skyrizi and Rinvoq driving growth. Humira erosion continued as neuroscience, oncology and pipeline assets supported the outlook.
A non-propagating VSV vector encoding H1/N1 antigens prevented detectable shedding of a drifted influenza challenge virus in pigs. The vaccine also induced cross-reactive immunity and inhibited avian N1 activity.
A retrospective real-world study of 108 Chinese patients with anti-TNF-refractory Crohn’s disease found upadacitinib clinical remission rates of 55.1% at week 12 and 52.5% at week 24.
