Curated news and analysis on clinical trials, drug approvals, and medical research.
FDA issued guidance on the Food Traceability Rule, finalized an exemption for IMS-listed Grade A cottage cheese, and announced a June 15, 2026 public meeting on lot-level traceability, as Congress bars enforcement funding until July 20, 2028.
EMA has initiated a rolling review of OS Therapies' OST-HER2 for preventing recurrence in fully resected pulmonary metastatic osteosarcoma. A potential conditional marketing authorization decision is expected in Q4 2026, with a confirmatory Phase 3 trial planned for Q3 2026 in Australia.
FDA clears Cloudbreak Pharma's IND for CBT-199, a novel presbyopia eye drop, allowing Phase 2 trials to proceed. The company also advances CBT-001 (Phase 3 for pterygium) and CBT-004 (Phase 3 for pinguecula).
Two studies show liquid biopsy can predict immunotherapy response in HER2-negative breast cancer and identify which patients with relapsed germ cell tumors may benefit from high-dose chemotherapy, advancing precision oncology.
Experts discuss balancing efficacy and safety in BTK inhibitor plus venetoclax combination therapy for CLL, including BTK lead-in strategies to reduce tumor lysis syndrome risk and the benefits of all-oral fixed-duration regimens.
A phase 3 trial of an mRNA H5N1 bird flu vaccine is recruiting 4,000 volunteers in the UK and US. The Moderna-sponsored study aims to assess immune responses against emerging strains as the virus continues to evolve in mammals.
GeoVax is advancing Gedeptin toward a Phase 2 trial in head and neck cancer and has secured an exclusive license from Emory University for Gedeptin-ICI combination technology. The therapy has Orphan Drug Designation for oral and pharyngeal cancers.
Immunome submitted an NDA to the FDA for varegacestat in desmoid tumors after the Phase 3 RINGSIDE trial showed an 84% reduction in progression risk (HR=0.16) and a 56% objective response rate. The company plans to file in Q2 2026.
Three FcRn inhibitors are approved for generalized myasthenia gravis, with a head-to-head trial of efgartigimod and nipocalimab underway. Emerging therapies including telitacicept, gefurulimab, and CAR-T cell therapy (KYV-101) show promise, while Immunovant's batoclimab failed TED trials.
Recent biosimilar and biologic developments included Health Canada approval of denosumab biosimilars, FDA review actions, and new licensing and commercialisation agreements. Other updates covered court, trial and reimbursement agenda decisions.
Q4 earnings were mixed across 17 tracked pharmaceutical companies. Elanco and ANI Pharmaceuticals beat revenue estimates, while Corcept and Amphastar missed. The XPH pharma ETF posted a 29% one-year return but significantly lagged the S&P 500 over five and ten years.
Single-cell RNA sequencing of nearly 92,000 cells from the DESTINY-Gastric06 trial reveals distinct primary and acquired resistance mechanisms to trastuzumab deruxtecan in HER2-positive gastric cancer, including MUC3A and CST3 as key drivers.
FDA approves AstraZeneca's Breztri Aerosphere as the first single-inhaler triple therapy for asthma in patients aged 12+, based on Phase III KALOS and LOGOS trials showing improved lung function and reduced exacerbations versus dual therapy.
Compass Therapeutics reported mixed Phase 2/3 data for tovecimig in biliary tract cancer and plans to meet with the FDA for a BLA discussion. The study met its primary ORR endpoint (17% vs 5%), while PFS and OS data are due late this quarter.
Aclaris Therapeutics outlined its TSLP antibody and ITK kinase pipeline at the Guggenheim Biotech Summit, with Phase II AD results for bosakitug due in late 2026 and Phase 1b studies for bispecific ATI-052 underway. The company will also announce Phase 1a results for ATI-052 and lead indication selection for ATI-2138 on April 28, 2026.
Novartis received EU approval for Rhapsido (remibrutinib) as the first oral targeted treatment for chronic spontaneous urticaria. Phase 3 data also showed significant efficacy in chronic inducible urticaria, with filings underway for additional indications.
Eli Lilly has launched two Phase 2 trials for brenipatide (LY3537031): RENEW-Op-1 for opioid use disorder and RENEW-Scz-1 for schizophrenia. Both are randomized, double-blind, placebo-controlled studies that are not yet recruiting as of February 2026.
A Johns Hopkins study found GLP-1 users face increased dementia risk after a decade, possibly due to longer lifespan. A separate JCI review found GLP-1 drugs show neuroprotective signals in preclinical studies but consistent cognitive benefits in humans remain unproven.
AbbVie filed an sBLA for SKYRIZI as a subcutaneous induction therapy for Crohn's disease, supported by Phase 3 AFFIRM data. SKYRIZI and Rinvoq combined for $25.9B in 2025 revenue, exceeding 2027 guidance. The FDA also approved Venclexta plus acalabrutinib in CLL.
GENFIT will receive a $20 million milestone from Ipsen after Iqirvo posted $208 million in 2025 net sales in primary biliary cholangitis. The sales also triggered a €30 million instalment under GENFIT’s royalty-financing deal.
