Curated news and analysis on clinical trials, drug approvals, and medical research.
The FDA has approved Agilent's PD-L1 IHC 22C3 pharmDx as a companion diagnostic for identifying esophageal cancer patients eligible for Merck's KEYTRUDA immunotherapy. This marks the eighth FDA-approved indication for this diagnostic test with KEYTRUDA. The test helps identify patients whose tumors express PD-L1 for potential treatment with the anti-PD-1 therapy.
A vaccine and two novel tuberculosis treatments are advancing through Phase III trials, marking renewed momentum in TB research. Tuberculosis claims over 1.25 million lives annually with 10.6 million new cases in 2023, while current treatments face challenges of high pill burden, toxicity, and rising resistance.
NIH funding uncertainty persists despite Congress rejecting budget cuts, with delays in grant dispersal and review processes creating challenges for biomedical researchers. The number of R01 grants dropped significantly from 2024 to 2025, and funding rates for both early-career and established researchers declined. Researchers face compressed timelines and administrative burdens that threaten scientific progress.
Orphan drug sales are projected to reach $400 billion by 2032, accounting for over 21% of prescription drug sales. Recent policy changes expanded IRA exemptions for multi-indication orphan drugs and reauthorized pediatric review vouchers. Johnson & Johnson's Darzalex leads orphan drug sales with $31 billion projected revenue.
Salem city councilors are considering spending $250,000 in opioid settlement funds for a new drug treatment and recovery program at Redwood Crossings supportive housing. The proposal comes as the city launches a broader "Prevent, Treat, and Enforce" initiative to address substance abuse through treatment, prevention, and law enforcement coordination.
Merck will acquire Terns Pharmaceuticals for $6.7 billion to bolster its cancer pipeline ahead of Keytruda's 2028 patent expiration. The deal gives Merck access to TERN-701, an oral tyrosine kinase inhibitor for chronic myeloid leukemia. Merck projects over $70 billion in commercial opportunities from its pipeline by the mid-2030s.
Amneal Pharmaceuticals recalls magnesium sulfate after a pouch intended for pregnant women was found containing tranexamic acid instead. The medication mix-up could cause serious adverse events including seizures and blood clotting if administered incorrectly.
The FDA has approved Lifyorli (relacorilant) plus nab-paclitaxel for platinum-resistant ovarian cancer based on trial data showing improved survival. Separately, the agency granted Breakthrough Therapy designation to Lilly's sofetabart mipitecan for the same condition, expediting development of the antibody-drug conjugate.
The FDA approved milsaperidone for bipolar I disorder and schizophrenia, while COMP360 psilocybin met its primary endpoint in a second phase 3 trial for treatment-resistant depression. Phase 2a data showed intravenous DMT (SPL026) significantly reduced depressive symptoms in major depressive disorder patients.
Precigen reported $3.4 million in first commercial sales of PAPZIMEOS in Q4 2025 following FDA approval for recurrent respiratory papillomatosis. The drug has received standard of care endorsement from physician experts and now covers approximately 90% of insured U.S. lives. The company has $100.4 million in cash and is pursuing European regulatory approval.
Researchers have identified KHDC1L as a circulating biomarker for DUX4 activity in facioscapulohumeral muscular dystrophy (FSHD). The discovery could enable non-invasive blood-based monitoring of disease progression instead of muscle biopsies. The finding emerged from collaboration between academic researchers and Avidity Biosciences scientists.
AIxCrypto Holdings reported its first full-year results after transforming from a biotech firm to an AI and blockchain infrastructure company. The company completed a $41.0 million PIPE financing, rebranded, and began Nasdaq trading in November 2025. Financial results show approximately $31 million in total assets, $19 million in cash, and platform metrics of over 5.8 million registered wallets.
Oral semaglutide demonstrated significant improvements in multiple cardiometabolic risk factors in adults with type 2 diabetes at high cardiovascular risk. The SOUL trial analysis showed reductions in systolic blood pressure, cholesterol, triglycerides, HbA1c, and body weight compared to placebo. These benefits were observed as early as 13 weeks and contributed to a 14% reduction in major adverse cardiovascular events.
Research shows chloramine disinfection successfully stopped a Legionnaires' disease outbreak in Minnesota, while clinical data reveals Legionella pneumonia has 11.9% 30-day mortality and disproportionately affects immunocompromised patients. The studies highlight both prevention strategies and diagnostic challenges.
Iterion Therapeutics has dosed the first patient in a phase 1/2 trial of its Wnt/β-catenin inhibitor tegavivint for metastatic colorectal cancer. The expansion builds on promising monotherapy activity observed in advanced hepatocellular carcinoma, targeting a pathway activated in over 90% of colorectal cancer patients.
NIH has obligated only 15% of its $38 billion budget halfway through the fiscal year, causing universities to cut PhD admissions and implement hiring freezes. Early-career scientists face declining grant success rates despite increased applications. Congress recently reversed proposed 40% NIH budget cuts that had threatened research facility construction.
A phase 1 trial shows denileukin diftitox administered before CAR-T therapy has a favorable safety profile and encouraging efficacy in high-risk DLBCL patients, with an 86% overall response rate and 77% one-year progression-free survival. The treatment demonstrated consistent regulatory T-cell depletion, supporting its immunomodulatory mechanism. Larger controlled studies are needed to confirm these preliminary findings.
PDS Biotechnology will report 2025 financial results and provide clinical updates on March 30, 2026. The company faces critical regulatory decisions for its Phase 3 VERSATILE-003 trial in HPV16-positive head and neck cancer and is expanding its immunotherapy platform to prostate cancer and other solid tumors.
China's newly revised Implementation Regulations of the Drug Administration Law will take effect on May 15, 2026, representing the first comprehensive revision in over two decades. The regulations strengthen the marketing authorization holder system, improve drug development processes, and introduce new provisions for clinical trials, data protection, and market exclusivity for pediatric and rare disease drugs.
Clinical trials show psychedelic substances like psilocybin, LSD and MDMA combined with therapy can effectively treat depression, anxiety and addiction. Several substances are in Phase III trials, with esketamine already approved for treatment-resistant depression. Research suggests these treatments may work with fewer doses than traditional medications.
