Curated news and analysis on clinical trials, drug approvals, and medical research.
The US Food and Drug Administration sent messages on 30 March to more than 2,200 companies and researchers tied to over 3,000 clinical trials over missing ClinicalTrials.gov results. The agency said 29.6% of studies highly likely to be subject to mandatory reporting had no results information submitted.
The FDA accepted Praxis Precision Medicines' NDA for ulixacaltamide in essential tremor and set a Jan. 29, 2027 PDUFA date. The filing is backed by positive Phase 3 Essential3 data.
The FDA has accepted Savara’s BLA for MOLBREEVI in autoimmune PAP and granted Priority Review with an action date of August 22, 2026. The application includes data showing improved pulmonary gas transfer, quality of life, and clinical symptoms.
The FDA granted full approval to Filspari to reduce proteinuria in patients aged eight and older with FSGS without nephrotic syndrome. The decision was based on Phase III DUPLEX data versus irbesartan.
A study in the Journal of Experimental Medicine found that DOCK8 deficiency drives severe food allergies by expanding Tfh13 cells and reducing regulatory T-cells. The findings help explain why DOCK8 mutations, but not STAT3 mutations alone, consistently lead to elevated food-specific IgE and clinically significant reactions.
Vir Biotechnology has dosed the first patient in a Phase I VIR-5500 expansion cohort for metastatic prostate cancer. The trial is evaluating VIR-5500 as monotherapy and in combination settings across mCRPC and mHSPC.
South Korean pharmaceutical companies are expanding digital healthcare businesses as they seek new revenue sources. The domestic market recorded 7.7409 trillion won in sales in 2024, while companies including Daewoong Pharmaceutical, Dong-A ST, Handok and Yuhan are advancing products and investments.
The Environmental Defence Society is seeking funding to scrutinise the proposed Bendigo-Ophir Gold Mine in the fast-track approvals process. It said its review found potentially significant and permanent environmental risks.
Corcept Therapeutics executives and directors were sued over alleged misstatements about a drug candidate’s approval prospects. The suit says insider stock sales totaled $97 million while the stock price was artificially inflated.
The Consolidated Appropriations Act, 2026 extends the FDA’s rare pediatric disease priority review voucher authority through Sept. 30, 2029. The law also requires a GAO report on the program’s effectiveness.
Daraxonrasib showed median overall survival of 13.2 months versus 6.7 months for chemotherapy in a Phase III trial in previously treated metastatic pancreatic adenocarcinoma. The once-daily pan-RAS(ON) inhibitor was generally well tolerated, and the company plans to seek FDA approval.
Sana Biotechnology named Brian Piper executive vice president and CFO as it advanced SC451 and SG293. The company reported a fourth-quarter loss of $59 million and cash of $138 million.
The FDA approved an updated Vabysmo label for macular edema following retinal vein occlusion beyond six months. The decision extends treatment based on data showing visual acuity gains and central subfield thickness reductions maintained through week 72.
Markets in 2026 are shifting from AI-driven valuation gains to earnings validation and quality. Higher rates, broader stock leadership and stronger non-U.S. returns are reshaping investor positioning.
The phase 3 AMPLIFY trial in frontline chronic lymphocytic leukemia showed improved efficacy with acalabrutinib plus venetoclax versus standard of care. The source text identified the study as NCT03836261.
The FDA cleared MiniMed Flex, a screen-free insulin pump controlled by smartphone, and granted breakthrough device designation to Portal Diabetes’ implantable Portal Pump system. Portal Diabetes also began a Phase I study of Portal Insulin, while MiniMed said Flex supports its latest algorithm, sensors and infusion sets.
University of Missouri researchers released PSBench, a database of 1.4 million annotated protein structure models verified by independent experts. The resource aims to improve AI assessment of protein models as biologic drug discovery moves toward data-driven design.
ARVO named Sangeetha Kandoi and Ellen Konadu Antwi-Adjei as the 2026 recipients of its annual Advocacy Awards. The honors recognize advocacy in eye and vision research and efforts to expand equitable access to care.
The FDA reminded more than 2,200 sponsors and researchers to submit required clinical trial results and said 29.6% of likely reportable studies lacked posted results. It also issued warning letters over CGMP violations at a contract manufacturer and protocol failures that led to excessive dosing in a clinical study.
PharmaMar and Globant deployed a multi-agent AI framework to accelerate oncology drug discovery. The system delivers over 90% accuracy in data retrieval and generates insights up to 15 times faster.
