Curated news and analysis on clinical trials, drug approvals, and medical research.
A study published in The Journal of Clinical Investigation found that CXCL11 may help drive endocrine resistance in some hormone receptor-positive breast cancers. Researchers said ED-resistant tumors had increased immune signaling and may be more responsive to immunotherapies.
PJM has proposed a two-phase Reliability Backstop Procurement and a framework for large new loads to bring their own generation or scale back usage. The plan could speed bilateral power deals for data centers while adding a backstop auction to address supply shortfalls.
Lenacapavir was launched in Zimbabwe in February 2026 as Kenya became the fourth African country to start administering the twice-yearly HIV prevention injection. The rollout follows launches in Eswatini and Zambia in December 2025, five months after US FDA approval.
Samsung Bioepis plans to start a global Phase 1 trial of SBE303, its first independently developed new drug candidate targeting Nectin-4. Preclinical data showed tolerability up to 40 mg/kg in monkeys.
Virginia lawmakers are again advancing a Prescription Drug Affordability Board bill, while Gov. Abigail Spanberger seeks amendments. The measure would create a board to analyze drug pricing and apply federal caps to state-regulated plans.
Breath Diagnostics said the FDA granted Breakthrough Device Designation to its OneBreath platform for pre-operative assessment of postoperative pneumonia risk in adults undergoing elective cardiac surgery. The single-breath test analyzes exhaled volatile organic compounds using LC-MS and is intended for use with clinical evaluation and standard risk assessment tools.
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.
