Curated news and analysis on clinical trials, drug approvals, and medical research.
The FDA has approved a monthly dosing schedule for Rybrevant Faspro in EGFR-mutated NSCLC and granted breakthrough therapy designation for the drug as monotherapy in HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma after prior therapy.
The FDA has agreed to review Moderna's mRNA influenza vaccine application after initially rejecting it, following modifications by the company. A decision is expected by August 5, 2026.
Teva and Sanofi reported positive 44-week data from the RELIEVE UCCD long-term extension study of duvakitug, showing durable efficacy in ulcerative colitis and Crohn's disease patients.
Compass Pathways reported positive phase 3 results for COMP360 psilocybin in treatment-resistant depression, showing statistically significant symptom reduction. The company plans to discuss FDA filing with a New Drug Application expected in Q4 2026.
The European Commission approved MYQORZO (aficamten) for treating symptomatic obstructive hypertrophic cardiomyopathy in adults, completing global regulatory approvals following FDA and China NMPA clearances. First European launch planned in Germany in Q2 2026.
Novo Nordisk sues telehealth companies over compounded weight-loss drugs as employers explore AI-based alternatives to costly GLP-1 medications. About 1 in 8 Americans now take GLP-1 drugs for weight loss or diabetes.
Janux Therapeutics has dosed the first participant in a Phase 1 clinical trial of JANX011, a CD19-targeted bispecific candidate designed using its ARM platform for autoimmune disease treatment.
Cyclerion Therapeutics received positive FDA feedback on its Phase 2 study design for CYC-126, an anesthetic-based therapy with real-time EEG monitoring for treatment-resistant depression, with study initiation planned for second half of 2026.
Portal Diabetes, Inc. announced FDA Breakthrough Device Designation for its implantable insulin pump system and initiated a Phase 1 study of its proprietary temperature-stable insulin for type 1 diabetes treatment.
The FDA has accepted Bristol Myers Squibb's new drug application for iberdomide combined with daratumumab and dexamethasone for relapsed or refractory multiple myeloma, with a target action date of August 17, 2026.
Ocular Therapeutix's Axpaxli met its primary endpoint in the SOL-1 Phase 3 trial, showing superior vision maintenance compared to aflibercept in wet AMD patients. The company plans to pursue FDA approval based on the results.
The FDA has recalled over 20,000 single-serve peanut butter products made by Ventura Foods after blue plastic fragments were found in a production filter. The Class II recall affects 40 states and multiple private-label brands.
NRx Pharmaceuticals completed a Type C meeting with the FDA, receiving guidance to file a New Drug Application for NRX-100 based on existing trial data and real-world evidence from over 65,000 patients, with submission planned for Q2 2026.
NRx Pharmaceuticals completed a Type C meeting with FDA leadership and received oral guidance supporting a New Drug Application for NRX-100 (preservative-free ketamine) based on existing trial data and Real World Evidence from over 65,000 patients.
The U.S. FDA has accepted Bristol Myers Squibb's New Drug Application for iberdomide combined with daratumumab and dexamethasone in patients with relapsed or refractory multiple myeloma, with a PDUFA date of August 17, 2026.
Recent studies reveal significant barriers in accessing mental health care for children and maternal health services, with nearly 25% of children's mental health needs going unmet and abortion restrictions linked to increased maternal deaths.
Pfizer announced positive results from Cohort 3 of the Phase 3 BREAKWATER trial, showing BRAFTOVI combined with cetuximab and FOLFIRI significantly improved progression-free survival in previously untreated BRAF V600E-mutant metastatic colorectal cancer patients.
Sygnature Discovery, a drug discovery contract research organisation, has announced a strategic brand relaunch including a new website to cement its position as a global drug discovery partner across Europe and North America.
Compass Pathways announced positive results from its second Phase 3 trial of synthetic psilocybin COMP360 for treatment-resistant depression, showing a 3.8-point reduction in depression scores. The company plans to meet with the FDA to discuss a rolling approval application.
ImmunityBio received European Commission authorization for ANKTIVA in bladder cancer, expanding to 33 countries. The company held productive discussions with Saudi regulators on recombinant BCG and checkpoint inhibitor combinations.
