FDA Accepts Replimune BLA Resubmission of RP1 for Advanced Melanoma
The FDA accepted Replimune’s BLA resubmission for RP1 plus nivolumab in advanced melanoma. The agency set an April 10, 2026 PDUFA date under a Class II resubmission timeline.
News & Analysis
Curated news and analysis on clinical trials, drug approvals, and medical research.
FDA draft biosimilar guidance removes animal toxicology and immunogenicity requirements
FDA draft biosimilar guidance released March 10, 2026 removes animal toxicology and immunogenicity requirements and accepts some non-U.S. comparator data. The changes are projected to cut development costs by up to 50%.
Image-Guided Therapy Systems Market Seen Reaching US$8.42 Billion by 2033
The image-guided therapy systems market is expected to grow from US$4.96 billion in 2024 to US$8.42 billion by 2033 at a 6.05% CAGR. Growth is tied to minimally invasive care, chronic disease demand, and advances in imaging, AI, and navigation systems.
Human study maps epoxy-oxylipin pathway that helps turn off inflammation
A human study found that epoxy-oxylipins help regulate inflammation and that GSK2256294 increased these molecules, reduced pain faster and lowered intermediate monocytes. The findings map epoxy-oxylipin activity in humans during inflammation.
Celltrion’s CT-P71 receives FDA Fast Track designation for urothelial cancer
Celltrion said CT-P71 received FDA Fast Track designation for previously treated locally advanced or metastatic urothelial cancer. The ADC candidate is in Phase 1 testing.
Paper urges Supreme Court to reject FDA labels as proof of patent infringement
A paper in the New England Journal of Medicine argues the Supreme Court should reject FDA-required drug labels as standalone evidence of patent infringement in Hikma Pharmaceuticals USA v. Amarin Pharma. The paper says lower-court guidance raises liability risk for generic-drug manufacturers complying with FDA rules and could hamper competition.
Novartis receives Buy ratings from Kepler Capital and Deutsche Bank
Novartis AG received Buy ratings from Kepler Capital and Deutsche Bank, with both setting price targets of CHF135.00. The company reported quarterly revenue of CHF13.44 billion and net profit of CHF2.43 billion for the quarter ended December 31.
10-Year Survival Similar With Chemoradiation or Surgery in Resectable Advanced NSCLC
Ten-year follow-up of the phase 3 ESPATUE trial found similar overall and progression-free survival with chemoradiotherapy boost or surgery in resectable advanced NSCLC after induction therapy.
Trump proposes new US science budget cuts as NIH overhead cap fight ends
Trump proposed significant cuts to major US science agencies for 2027, including a 13% reduction for the NIH and a nearly 55% cut for the NSF. The administration also let lapse its Supreme Court deadline in a separate fight to cap NIH research overhead payments at 15%.
Dr. Reddy's says FDA accepted abatacept biosimilar BLA for review
Dr. Reddy's said the FDA accepted for review its 351(k) BLA for DRL_AB, a proposed interchangeable biosimilar to ORENCIA. The application covers an IV formulation for RA, PsA and pJIA.
AbbVie updates Phase 2 elezanumab study in acute cervical spinal cord injury
AbbVie updated its completed Phase 2 elezanumab study in acute traumatic cervical spinal cord injury. The placebo-controlled trial began in March 2020 and its latest public update was posted on February 9, 2026.
FDA Approves First Oral IL-23 Therapy for Psoriasis as Studies Show Site-Specific Responses
The FDA has approved icotrokinra, the first oral IL-23 therapy for moderate-to-severe plaque psoriasis. Meanwhile, real-world research shows IL-23 inhibitors produce site-specific responses in high-impact areas like scalp and nails, and combination therapy with ixekizumab and tirzepatide shows superior results for psoriasis patients with obesity.
FDA Grants Fast Track to SIM0505 for Platinum-Resistant Ovarian Cancer
The FDA granted fast track designation to SIM0505, a CDH6-targeting antibody-drug conjugate, for platinum-resistant ovarian cancer based on preclinical and early clinical data. A phase 1 trial is currently evaluating the drug in advanced solid tumors, with initial data expected at the 2026 ASCO conference. The company plans to begin dose optimization studies in ovarian cancer patients in Q2 2026.
DMD Care Expands With Multidisciplinary Management, Earlier Pathology Focus
Duchenne muscular dystrophy care is shifting toward broader multidisciplinary management and closer attention to early pathology, biomarkers, and treatment timing. Clinicians described an expanding treatment landscape and identified neurology, cardiology, pulmonary, and endocrinology as core priorities.
Pediatric hypertriglyceridemia guidance sharpens risk-based screening and management
Updated pediatric hypertriglyceridemia guidance says triglyceride thresholds below 400 mg/dL mainly signal ASCVD risk, while levels above about 885 mg/dL raise pancreatitis risk. Lifestyle changes remain first-line treatment, and pediatric-specific evidence for drug therapy is still limited.
Post-Mastectomy Pain Syndrome Afflicts Thousands, Often Undiagnosed and Dismissed
Post-mastectomy pain syndrome affects 10-50% of women after breast removal surgery, causing chronic pain that can last years. The condition lacks consistent diagnosis, standardized screening, and FDA-approved treatments, leaving many patients struggling to find relief. Recent research calls for increased focus on this undertreated complication of breast cancer survival success.
ALX Oncology sets 2026 data milestones for Evorpacept and ALX2004
ALX Oncology has multiple 2026 catalysts for Evorpacept and ALX2004. Interim ASPEN-09 data are expected in Q3 2026, while an initial safety update from the phase 1 ALX2004 trial is expected in 1H 2026.
Machine Learning Model Links Insulin Resistance to 12 Cancer Types
Researchers have used a machine learning model called AI-IR to demonstrate that insulin resistance is a risk factor for 12 types of cancer. The tool analyzes nine clinical parameters from standard health checkups to predict insulin resistance at population scale. This provides the first large-scale evidence linking insulin resistance to multiple cancers.
Enanta Pharmaceuticals to Present Zelicapavir RSV Data at ESCMID Global 2026
Enanta Pharmaceuticals will present Phase 2b data showing zelicapavir improves RSV symptom resolution by about a week and reduces hospitalization rates. The oral N-protein inhibitor also demonstrates high resistance barrier in pediatric studies. Presentations will occur at the ESCMID Global 2026 conference in Munich.
Korean Biotechs to Present Next-Gen Cancer Therapies at AACR Meeting
Korean biotech firms will present next-generation cancer therapies at the AACR meeting, including CAR-T platforms for solid tumors, mRNA-based treatments, radiopharmaceuticals, and bispecific antibody ADCs. Companies like AbClon, Verismo Therapeutics, Hanmi Pharmaceutical, and SK Biopharmaceuticals will showcase their latest research.
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