Operation Stork Speed Prepares to Overhaul U.S. Baby Formula Guidelines
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.
News & Analysis
Curated news and analysis on clinical trials, drug approvals, and medical research.
Healthcare AI Faces a Human-Test Reality Check
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.
Daratumumab marks shift toward early intervention in smoldering multiple myeloma
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 finalizes seventh new US facility in $23 billion expansion
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.
UAE launches gene therapy projects for autism and rare brain disorders in children
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 Awaits Phase 3 Avexitide Data and Pipeline Updates
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 enrolls first patient in BENEFIT-HF heart failure trial
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 Show Remission, Durable Response and Low Switch Rates
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.
Gedatolisib combinations beat alpelisib regimen in PIK3CA-mutant HR-positive breast cancer
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 reports 2025 profitability as AMVUTTRA drives revenue growth
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.
Global antibody drug conjugate market seen reaching $32.66 billion by 2035
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 selects rinzimetostat Phase 3 dose and expects Himalayas-1 start in 1H 2026
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 raises 2026 revenue guidance after Amicus acquisition and FDA PALYNZIQ expansion
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 completes rolling BLA submission for povetacicept after positive Phase 3 IgAN data
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 Names Three New Clinical Leaders
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.
Diabetic retinal disease studies link DME and retinopathy severity to higher dementia risk
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 raises 2026 guidance as Skyrizi and Rinvoq drive growth
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.
VSV-vectored H1/N1 vaccine prevented shedding of drifted influenza virus in pigs
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.
Real-world study reports upadacitinib outcomes in anti-TNF-refractory Crohn’s disease
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.
Gut procedure may help patients keep weight off after stopping tirzepatide
An experimental gut procedure helped a small group of patients maintain up to 80% of weight loss after stopping tirzepatide. A larger trial involving more than 300 people is underway.
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