Curated news and analysis on clinical trials, drug approvals, and medical research.
The global CRISPR and prime editing market is forecast to grow at 24.1% CAGR through 2031, driven by therapeutic advances and regulatory progress. Scribe Therapeutics achieved a second milestone with Eli Lilly, while new RNA production and gene editing technologies accelerate research.
The FDA has expanded approval of Wakix (pitolisant) to treat cataplexy in pediatric patients aged 6 years and older with narcolepsy, making it the first non-controlled substance approved for both pediatric and adult narcolepsy patients with or without cataplexy.
A 24-year-old woman with refractory lupus achieved two successful pregnancies following dual-target CAR-T cell therapy, while bispecific T cell engagers showed efficacy in treatment-refractory antisynthetase syndrome and systemic sclerosis patients.
Researchers at Stony Brook University developed an oral vaccine using modified Listeria monocytogenes that generates anti-tumor immune responses in the gut and significantly improves colorectal cancer control when combined with checkpoint inhibitors.
Eli Lilly reported Q4 2025 EPS of $7.54 versus $6.67 expected and projected 2026 revenue of $80-83 billion. Mounjaro revenue surged 110% to $7.4B while Zepbound jumped 123% to $4.2B in Q4.
BioNTech filed a patent infringement lawsuit against Moderna in Delaware federal court, alleging the company's newly approved mNEXSPIKE vaccine uses proprietary mRNA technology without authorization.
Gossamer Bio's seralutinib narrowly missed its primary endpoint in the Phase 3 PROSERA study for pulmonary arterial hypertension, achieving a p-value of 0.0320 versus the prespecified threshold of 0.025, though showing stronger results in intermediate- and high-risk patients.
The FDA has accepted Ultragenyx's BLA for DTX401, an AAV gene therapy for Glycogen Storage Disease Type Ia, granting Priority Review with a PDUFA action date of August 23, 2026.
A new Cochrane review of 22 randomized trials finds intermittent fasting produces little to no meaningful weight loss compared to traditional dietary advice or no intervention in overweight or obese adults.
Another participant with metastatic castration-resistant prostate cancer achieved undetectable PSA and negative PSMA PET after treatment with 67Cu-SAR-bisPSMA in the SECuRE trial. This marks the fifth patient to achieve undetectable disease by radiographic assessment in Clarity Pharmaceuticals' program.
CagriSema demonstrated 23% weight loss in the REDEFINE 4 trial but failed to meet its primary endpoint of non-inferiority compared to tirzepatide's 25.5% weight loss. The company submitted an FDA application in December 2025 based on earlier pivotal trials.
Study of 3600 older adults with type 1 diabetes across US and European registries reveals significant gaps in guideline-recommended cardiovascular therapies and diabetes technology use despite high disease burden.
Trader Joe's recalled chicken fried rice nationwide due to possible glass contamination after four customer reports. Separately, the FDA expanded a recall of McCain Foods tater tots to 648,000 pounds over plastic fragment concerns.
Microdosing GLP-1 medications like Ozempic and Wegovy has emerged as a weight-loss trend, but health experts warn there is no scientific data supporting the practice and caution about potential safety risks.
The FDA has accepted for review Beren Therapeutics' NDA for adrabetadex in infantile-onset Niemann-Pick disease type C with a PDUFA date of August 17, 2026, and Dr. Reddy's BLA for a biosimilar to Orencia (abatacept).
Novartis announced positive topline results from its Phase III RemIND trial of remibrutinib in chronic inducible urticaria, meeting the primary endpoint for the three most prevalent types of the condition with significantly higher complete response rates versus placebo.
Two clinical trials demonstrate efficacy of talimogene laherparepvec (T-VEC) oncolytic virus therapy in HER2-negative breast cancer and nonmelanoma skin cancers, with favorable safety profiles and durable responses in subset of patients.
A phase 2 trial found that a single intravenous dose of dimethyltryptamine (DMT) alongside psychotherapy significantly reduced major depressive disorder symptoms, with effects lasting up to 6 months.
A multicenter study of over 500 children found no differences in neurodevelopmental outcomes between offspring of mothers who received mRNA COVID-19 vaccines during pregnancy and those who did not.
A 6-3 Supreme Court decision rejected unlimited presidential tariff authority under IEEPA, constraining mega-tariffs while Section 232 pharmaceutical investigations and potential duties on branded medicines remain in effect.
