Curated news and analysis on clinical trials, drug approvals, and medical research.
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.
The global pancreatic cancer precision medicine market is projected to grow from US$ 610 million in 2024 to US$ 2,467.83 million by 2033 at a 16.8% CAGR, driven by advances in targeted therapies, genomic diagnostics, and liquid biopsies.
Nuclera and leadXpro announced a scientific partnership combining rapid multiplex membrane protein screening with AI/ML-driven construct design to accelerate structure-based drug discovery for challenging membrane protein targets.
BioNxt Solutions Inc. receives European Patent No. 4539857 for its proprietary sublingual cladribine oral thin film drug delivery technology, providing protection across up to 39 European Patent Convention states through at least June 14, 2043.
The European Commission has approved GSK's Exdensur (depemokimab) as the first ultra-long-acting biologic for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps, offering twice-yearly dosing based on positive phase 3 trial results.
The CBSE Class 12 Biotechnology Board Examination was conducted on February 17, 2026, as part of the annual board examinations. The exam was held for 70 marks with a moderate difficulty level reported by students.
The Consolidated Appropriations Act of 2026 extends the FDA's authority to award rare pediatric disease priority review vouchers through September 30, 2029, restoring a key incentive for developing therapies for rare pediatric diseases.
New clinical trial data show trastuzumab deruxtecan plus pertuzumab extends progression-free survival as first-line therapy, while MRI-guided treatment shortening reduces toxicity in neoadjuvant settings for HER2-positive breast cancer.
Scientists are developing blood tests that can detect cancer years before symptoms appear, including CRISPR-powered sensors and multi-cancer early detection tests that identify molecular warning signs in the bloodstream.
