Drug Development
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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.
FDA Approves First ctDNA-Guided Adjuvant Immunotherapy for Bladder Cancer, Rewriting the Post-Surgery Treatment Playbook
Atezolizumab becomes the first therapy cleared for use only in patients whose blood tests reveal molecular residual disease after bladder removal surgery.
FDA Approves Baxfendy, the First Aldosterone Synthase Inhibitor for Uncontrolled Hypertension
AstraZeneca's baxdrostat (Baxfendy) became the first aldosterone synthase inhibitor approved in the US on May 18, 2026, giving the estimated 23 million Americans whose blood pressure remains uncontrolled on two or more drugs a new mechanistic option.
Cytisinicline Heads Toward FDA Decision as Long-Term Safety Data Backs First New Smoking Cessation Drug in Two Decades
Fresh 52-week safety data presented at ATS 2026 reinforce cytisinicline's profile ahead of a June 20 FDA decision that could bring the first new smoking cessation drug to US patients since 2006.
Nine Weeks of Immunotherapy Before Surgery Leaves Every Bowel Cancer Patient Relapse-Free After 33 Months in NEOPRISM-CRC Trial
A UK trial of preoperative pembrolizumab for MMR-deficient colorectal cancer shows zero relapses across all 32 patients after nearly three years of follow-up.
FDA Approves Enhertu for Two HER2-Positive Early Breast Cancer Indications, Moving the AstraZeneca-Daiichi ADC Into Curative-Intent Treatment
AstraZeneca and Daiichi Sankyo's trastuzumab deruxtecan won simultaneous neoadjuvant and adjuvant approvals on May 15, backed by 927-patient DESTINY-Breast11 and 1,635-patient DESTINY-Breast05 Phase III trials.
NEJM Publishes Phase 1/2 Data for Daraxonrasib as FDA Authorizes Expanded Access for Metastatic Pancreatic Cancer
NEJM publishes Phase 1/2 data for oral RAS(ON) inhibitor daraxonrasib (~30% ORR, 90% disease control in pretreated patients); FDA issues 'safe to proceed' for EAP on May 1, now available for eligible metastatic PDAC patients.
AstraZeneca's Eneboparatide Frees 31% of Hypoparathyroidism Patients From Calcium and Vitamin D at Week 24 in CALYPSO Phase III
AstraZeneca's CALYPSO Phase III hit its composite primary endpoint with 31.1% of eneboparatide patients normalizing serum calcium and dropping supplements at week 24 versus 5.9% on placebo, with benefits sustained through a 52-week extension.