Biotech & Medicine
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AI-Designed 'Universal' Coronavirus Vaccine Passes First Human Trial, Showing Safety but Modest Immune Response
Cambridge spin-out DIOSynVax's pEVAC-PS, the first vaccine whose active ingredient was designed entirely by computer, proved safe in 39 volunteers but produced only modest immunity.
Obexelimab Cuts IgG4-Related Disease Flares by 56% in Phase 3 INDIGO Trial, Published in NEJM
Zenas BioPharma's obexelimab met its primary endpoint and all four key secondary endpoints in the Phase 3 INDIGO trial, with results published in NEJM and presented at EULAR 2026.
OPTIMA Trial Finds a Gene-Expression Test Can Spare Two-Thirds of High-Risk Breast Cancer Patients From Chemotherapy
The 4,429-patient Phase III OPTIMA trial found that a Prosigna ROR-guided strategy was non-inferior to standard chemotherapy in ER-positive, HER2-negative early breast cancer, letting 68% of clinically high-risk patients skip chemo.
FDA Issues Draft Guidance Letting Gene-Editing Developers Reuse Platform Data Across Products to Speed Submissions
The FDA's June 2 draft guidance lets genome-editing sponsors leverage prior CMC, nonclinical, and clinical knowledge across products, with a 90-day comment window.
FDA Approves Xocova as First Oral COVID-19 Post-Exposure Prevention Drug, Based on Phase 3 Trial Showing 67% Risk Reduction
The FDA has approved Shionogi's ensitrelvir (Xocova) for post-exposure prophylaxis of COVID-19, the first oral antiviral cleared for that indication in the US.
Replimune's Oncolytic Virus Achieves 47.8% Three-Year Survival in Checkpoint-Resistant Melanoma as Company Lines Up Third FDA Submission
IGNYTE trial data show 83.5% of responders alive at three years; Replimune plans third BLA resubmission after two FDA rejections.
FDA Approves Decnupaz, the First CD123-Targeting ADC for a Blood Cancer With Historically Dismal Prognosis
AbbVie's pivekimab sunirine-pvzy wins FDA approval for BPDCN on May 27, with a 69.7% complete remission rate in newly diagnosed patients and the first-ever outpatient initiation for this ultra-rare malignancy.
FDA Approves First All-Oral AML Regimen as Inqovi Plus Venetoclax Clears for Patients Ineligible for Intensive Chemotherapy
The FDA on May 13 cleared Taiho Oncology's Inqovi combined with venetoclax as the first fully oral treatment for older or unfit AML patients, replacing injection-based clinic visits.
Lilly's VERVE-102 Base Editor Cuts LDL Cholesterol by 62% in Phase 1b Trial, Results Published in NEJM
A single infusion of VERVE-102 reduced LDL-C by up to 62% and PCSK9 by up to 88% in a 35-patient trial, with effects sustained up to 18 months.
Scribe Therapeutics Wins TGA Clearance to Begin First Human Trial of STX-1150, a CRISPR Epigenetic Therapy Targeting PCSK9
Scribe's ELXR platform silences PCSK9 in the liver without cutting DNA; a single low dose sustained LDL reductions for roughly 18 months in primates.
US Measles Cases Hit 1,952 as Country Edges Toward Losing Elimination Status It Has Held Since 2000
The CDC logged 1,952 measles cases through May 21, 2026 — on pace to surpass last year's high not seen since 1992 — as a Lancet study concludes four of seven elimination indicators have already been missed.
Lilly Acquires Engage Bio for Up to $202 Million to Build Non-Viral DNA Delivery Platform
Eli Lilly acquired Engage Bio and its Tethosome non-viral DNA delivery platform for up to $202 million, aiming to overcome the immune and redosing limits of viral gene therapies.