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Mar 20, 2026
Aquestive Therapeutics received a Complete Response Letter from the FDA for Anaphylm (dibutepinephrine) sublingual film, citing deficiencies in human factors validation and packaging. The company plans to resubmit as early as Q3 2026.
Mar 20, 2026
A class action lawsuit was filed against REGENXBIO covering the period from February 9, 2022 to January 27, 2026, following FDA clinical holds on gene therapies RGX-111 and RGX-121 after a CNS tumor was discovered in a trial participant.
Mar 19, 2026
Insilico Medicine announced a partnership with China Medical System Holdings for AI-powered drug discovery and nominated ISM5059, an NLRP3-targeted drug candidate, for preclinical development following recent FDA IND approval for another AI-created drug.
Mar 19, 2026
The FDA has released draft guidance to help drug developers validate new approach methodologies as alternatives to animal testing, marking a milestone in the agency's roadmap to reduce reliance on animal studies in drug development.
Mar 19, 2026
Global pharmaceutical R&D deal values surged 49% to $86.7 billion in 2025 as companies concentrate investments in AI-powered drug discovery platforms, with average deal sizes reaching a record $1.16 billion despite fewer total partnerships.
Mar 19, 2026
The U.S. FDA has granted Fast Track designation to FluoGuide's FG001 as an intraoperative imaging agent for high-grade glioma surgical resection. The designation follows IND clearance in January and enables accelerated development and regulatory review.
Mar 19, 2026
Analysis shows around a third of 54 drugs on TrumpRx.gov are cheaper in the UK, while the platform offers significant savings primarily for obesity and fertility drugs not typically covered by insurance.
Mar 19, 2026
Syndax Pharmaceuticals announced a collaboration to expand global access to Revuforj while reporting strong commercial performance for its two marketed products, with Revuforj generating $125 million and Niktimvo $152 million in the first 11 months of sales.
Mar 18, 2026
The FDA is set to make decisions on four drug applications in April 2026, including Orca-T for hematological malignancies, orforglipron for obesity, sparsentan for kidney disease, and a doravirine/islatravir combination for HIV-1.
Mar 18, 2026
Diakonos Oncology's Phase 2 glioblastoma trial of DOC1021 continues after independent safety review found no concerns. The company will present clinical data on the dendritic cell therapy at AACR and AAN conferences in April 2026.
Mar 18, 2026
Agentic AI models are streamlining oncology clinical trial design and reducing phase II to III failure risk. Separately, Aethlon Medical progresses its Hemopurifier device trial in Australia with strong safety data and accelerated patient recruitment.
Mar 18, 2026
The FDA issued a complete response letter rejecting Aldeyra Therapeutics' reproxalap for dry eye disease, marking the third rejection in three years due to inconsistent trial results and lack of substantial evidence of efficacy.
Mar 17, 2026
Over 25 companies are developing 30+ therapies for celiac disease, with recent positive trial results and FDA Fast Track designation. A new blood test using T-cell receptor sequencing may enable noninvasive diagnosis and monitoring.
Mar 17, 2026
The FDA has expanded approval of GSK's Arexvy RSV vaccine to include adults aged 18 to 49 years at increased risk for lower respiratory tract disease, based on phase 3b trial data showing noninferior immune response.
Mar 17, 2026
CAR T-cell therapy demonstrates near-98% response rates in multiple myeloma trials, but only 2.6% of eligible patients receive treatment. Black patients face substantially lower access, with structural and institutional barriers limiting availability of the specialized therapy.
Mar 17, 2026
Mayo Clinic researchers found that Brigatinib, an FDA-approved lung cancer drug, can block survival pathways in ovarian cancer cells when combined with PARP inhibitors, potentially overcoming treatment resistance.
Mar 17, 2026
Global orphan drug sales are forecast to reach $409 billion by 2032, representing one-fifth of prescription drug sales, with Johnson & Johnson and Argenx leading the market amid regulatory uncertainty.
Mar 17, 2026
Diagnosing rare diseases can take 3 to 15 years, while about 95% lack approved treatments. Families are advocating for regulatory changes to speed access to therapies as new digital tools aim to improve clinical trials.
Mar 17, 2026
At least seven people in California, Florida, and Texas have been sickened by E. coli linked to cheddar cheese made from raw milk by California-based Raw Farm. The company has declined to voluntarily recall its products.
Mar 17, 2026
Recent studies demonstrate high response rates for antibody-drug conjugate in rare blood cancer, improved outcomes with metastasis-directed radiation in prostate cancer, and a novel drug combination strategy for ovarian cancer resistance.
