FDA Grants Priority Review to Bayer's Finerenone for Type 1 Diabetes Kidney Disease
The U.S. FDA accepted Bayer's supplemental NDA and granted priority review to finerenone (Kerendia) for chronic kidney disease in adults with type 1 diabetes. The decision follows a phase‑3 trial that cut urine albumin‑to‑creatinine ratio by about 25% in 242 patients, offering the first nonsteroidal mineralocorticoid receptor antagonist for this high‑need group.
NeuroScientific Hails 80% Clinical Response in Crohn’s Stem Cell Program
NeuroScientific Biopharmaceuticals reported that four of five patients with fistulising Crohn’s disease showed a clinical response to its StemSmart mesenchymal stem cell therapy, an 80% response rate. All participants experienced symptom improvement and no serious adverse events were recorded. The...
Vividthree Warns of FY26 Revenue Decline and Net Loss
Vividthree Holdings Ltd. announced that its unaudited FY26 results will show a net loss driven by reduced revenue, goodwill impairments from recent acquisitions, and fair‑value losses on investments. The board urged shareholders to exercise caution while the company finalises its...
Caliway Secures FDA IND Clearance, Launches Global Phase 3 Trial for CBL‑514
Caliway Biopharmaceuticals received U.S. FDA clearance of its IND for CBL‑514, enabling a global Phase 3 study that will enroll about 320 participants across the United States, Canada and Australia. The trial’s rigorous MRI‑based endpoints aim to set a new efficacy...
SPARK Microgravity to Launch Live Cancer Cells in Microgravity Test Flight
SPARK Microgravity is set to launch a micro‑payload containing live triple‑negative breast cancer cells aboard an SSC Space rocket from Esrange, Sweden, in May 2026. The mission, the company’s first oncology‑focused flight, seeks to prove that cancer cells can be...
Eli Lilly's VERVE-102 Gene Therapy Cuts PCSK9 and LDL‑C in Phase 1b Heart‑2 Trial
Eli Lilly announced that a single infusion of its investigational base‑editing therapy VERVE-102 produced dose‑dependent reductions in circulating PCSK9 protein and LDL‑C in the Phase 1b Heart‑2 trial of adults with heterozygous familial hypercholesterolemia or premature coronary disease. The FDA...
New Maternal RSV Vaccine Lowers Infant Hospitalization Rates, but Accessibility May Be Limited, Study Finds
A new maternal RSV vaccine introduced in fall 2023 reduces infant hospitalizations, with the Dallas study showing zero hospitalizations among vaccinated infants versus 3% among unvaccinated. Vaccination rates varied sharply by insurance type and race, with private‑insured mothers at 37%...
Peptides / Bioregulators
Therapeutic peptide development has accelerated over the past decade thanks to new synthesis, modification, and analytical platforms, positioning peptides as a fast‑growing drug class. While FDA‑approved peptides remain limited to GLP‑1 analogues and a handful of niche indications, a flood...
Response to Comments on "Aluminium Adjuvants in Vaccines and Potential Health Effects: Systematic Review"
The authors of a BMJ systematic review on aluminium adjuvants in vaccines rebut criticisms by highlighting methodological flaws in cited studies and reaffirming that no causal association has been identified. They note that the Joura 2015 HPV vaccine trial cannot...
Nanotech Drug‑Delivery Market Set to Hit $179 B by 2033, DataM Reports
DataM Intelligence announced that the global nanotechnology‑enabled drug delivery devices market, valued at $54.22 billion in 2024, is projected to climb to $179.12 billion by 2033, expanding at a 12.6% compound annual growth rate. The forecast underscores accelerating commercial interest in precision‑medicine...
Roswell Park Scientists Present Five Key Cancer Studies at Clinical Meeting
Roswell Park Comprehensive Cancer Center will showcase five of its own studies at the ASCO 2026 Annual Meeting in Chicago, alongside additional research presented by its faculty and fellows. Highlights include a real‑world analysis of GLP‑1 receptor agonists on hormone‑receptor‑positive breast cancer,...
World Blood Cancer Day 2026: New FDA Approvals and Phase III Readouts
World Blood Cancer Day 2026 highlights a projected 180,000 new U.S. blood‑cancer cases, underscoring the disease’s growing burden. The FDA granted several approvals, including an all‑oral decitabine/cedazuridine‑venetoclax regimen for older AML patients and Beqalzi for relapsed mantle‑cell lymphoma. Janssen’s Tecvayli...
AstraZeneca, Daiichi Drug Approved as New First-Line Therapy for Tough Type of Breast Cancer
The FDA granted accelerated approval to Datroway (DS‑1062), an antibody‑drug conjugate co‑developed by Daiichi Sankyo and AstraZeneca, as a first‑line therapy for metastatic triple‑negative breast cancer (TNBC). Phase 3 data showed Datroway reduced the risk of disease progression or death by 43%...
ATP2B4 Boosts Chromatin Compaction, Worsens Pancreatic Cancer Radiotherapy Resistance
Researchers have identified the calcium pump ATP2B4 as a driver of chromatin compaction that shields pancreatic tumor DNA from radiation damage. Elevated ATP2B4 levels were detected in roughly two‑thirds of pancreatic ductal adenocarcinoma samples, correlating with poorer radiotherapy outcomes. Genetic...
Shanghai Center Reports First‑in‑China CAR‑T Success for Pakistani Lymphoma Patient
Jiahui International Cancer Center in Shanghai treated a 36‑year‑old Pakistani lymphoma patient with a customized CAR‑T therapy, leading to rapid pain relief and tumor shrinkage. The case underscores the growing role of Chinese CAR‑T programs in serving international patients with...
FDA Grants Accelerated Approval to Gilead’s Hepcludex, First U.S. HDV Therapy
The U.S. FDA has granted accelerated approval to Gilead Sciences' Hepcludex (bulevirtide‑gmod) 8.5 mg, creating the first FDA‑cleared therapy for chronic hepatitis delta virus (HDV) in the United States. The decision rests on Phase 3 MYR301 data showing virologic and biochemical improvements,...
Discovery of Novel 11 Beta-Hydroxysteroid Dehydrogenase Type 1 Inhibitor by Machine Learning Enabled Large-Scale Virtual Screening
Researchers applied a machine‑learning‑driven virtual screening workflow to the Mcule catalog of roughly 139.6 million compounds, ultimately identifying a single top candidate, MCULE‑6869845113, as a potent 11beta‑HSD1 inhibitor. The Gradient Boosting Classifier achieved an AUC of 0.88 and Matthews Correlation Coefficient...
Thioflavin-T Derivatives: Novel One- & Two-Photon Amyloid Markers
Researchers have unveiled a new class of thioflavin‑T derivatives that function as both one‑photon and two‑photon fluorescent markers for amyloid aggregates. The compounds exhibit markedly higher quantum yields, expanded two‑photon cross‑sections, and superior photostability compared with the classic Thioflavin‑T dye....
Four Decades of Glioblastoma Targeted Therapy: A Bibliometric and Pharmacological Perspective on Translational Failure and Future Directions
Over the past four decades, more than 5,000 studies have examined targeted therapies for glioblastoma (GBM), yet clinical success remains elusive. The United States and China dominate the research output, with the field progressing through four phases: molecular discovery, first‑generation...
Hyperbranched Biorefinery Molecule‐Regulated Switchable Adhesion and Noninvasive Healing
Researchers have created a reversible biomedical adhesive using a hyperbranched polysaccharide produced via microbial fermentation. The nanoconfined structure supplies abundant dynamic disulfide bonds, delivering both high adhesive strength and a broad, controllable adhesion range (296 N/m down to 17 N/m). In animal...
Fragments in the Clinic: VVD-214
Vividion’s covalent WRN inhibitor VVD‑214 evolved from a vinyl‑sulfone fragment hit (compound 1a) to a clinically viable candidate through a series of empirical SAR steps. Introducing a methyl group (2a) boosted stability and sub‑micromolar cellular potency, while a tert‑butyl cyclopentyl...
REGENXBIO's RGX-202 Gene Therapy Hits Pivotal Efficacy Endpoint in Duchenne Trial
REGENXBIO announced that its one‑time AAV microdystrophin therapy RGX-202 met the primary endpoint in the pivotal phase III AFFINITY DUCHENNE trial, with 93% of evaluable patients showing at least 10% protein expression at week 12. The result positions the company...
Tri‑complex RAS Inhibitors: 40k Compounds,
Came across this great talk from $RVMD's Adrian Gill on @drughunter_com about the development of probably one of the most important oncology drug classes in history : Tri-complex RAS inhibitors. It's not too technical so non-chemists can follow as well. Synthesized...
One-and-Done Heart Disease Prevention? Scientists Show It May Be Possible.
Scientists reported that a single infusion of an experimental gene‑editing drug lowered LDL cholesterol by up to 62 percent in an interim analysis of 35 patients. The reduction remained durable in a subgroup treated 18 months earlier, suggesting a potentially...
Agios Reports the EC Approval of Pyrukynd for Anemia in Alpha or Beta Thalassemia
The European Commission has granted approval for Agios' oral pyruvate kinase activator Pyrukynd (mitapivat) to treat anemia in adults with both non‑transfusion‑dependent and transfusion‑dependent alpha‑ or beta‑thalassemia. The decision follows positive results from the global Phase III ENERGIZE and ENERGIZE‑T trials,...
Eli Lilly’s Retatrutide Delivers up to 30% Weight Loss in Phase 3 Trial
Eli Lilly announced that its experimental triple‑agonist retatrutide produced an average 28.3% weight loss (about 70 lb) in the highest dose group of its Phase 3 TRIUMPH‑1 trial, with nearly half of those participants shedding at least 30% of body weight. The result...
Eisai Sets FY2028 Revenue Goal of ¥1 Trillion ($6.7B) on Oncology, Dementia Growth
Japanese drugmaker Eisai announced a FY2028 revenue target of ¥1 trillion (about $6.7 bn), underpinned by projected sales of its Alzheimer’s antibody Leqembi, insomnia drug Dayvigo and cancer therapy Lenvima. The guidance marks a steep climb from FY2025 and signals confidence in...
Pharming Reports the EC Approval of Joenja (Leniolisib) for Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS)
The European Commission has granted marketing authorization for Pharming’s oral PI3Kδ inhibitor Joenja (leniolisib) to treat patients aged 12 and older with activated phosphoinositide 3‑kinase delta syndrome (APDS) across all 30 EEA states. Approval is based on a Phase II/III...
Alcidian Secures $23 Million Deal with University Hospitals Sussex for Miya Precision EPR Platform
Alcidian Group announced a 7‑year contract worth about A$35 million ($23 million) with University Hospitals Sussex to implement its Miya Precision electronic patient record (EPR) platform. The agreement will generate roughly A$8.5 million ($5.6 million) in revenue for Alcidian in fiscal 2026, expanding the...
Clinical Trial Endpoint by Counting Hairs - Story of Clinical Trials in Androgenetic Alopecia (Hair Loss)
Veradermics announced that its extended‑release oral minoxidil (VDPHL01) met primary endpoints in a pivotal Phase 2/3 trial of 519 men with androgenetic alopecia. The study showed a mean increase of 30.3 hairs/cm² (once‑daily) and 33.0 hairs/cm² (twice‑daily) in non‑vellus target‑area hair...
Caliway Secures FDA Clearance for CBL-514 Clinical Trial
Caliway Biopharmaceuticals received FDA clearance for its CBL‑0302 IND application, clearing the path for a pivotal global Phase III trial of CBL‑514 aimed at reducing abdominal subcutaneous fat. The double‑blind, placebo‑controlled study will enroll roughly 320 participants in the United States, Canada...
Late-Breakers to Look Out for at ASCO 2026
ASCO 2026’s late‑breaker session will unveil a slate of pivotal trials that could reshape treatment algorithms across liver, bladder, pancreatic, prostate, multiple myeloma and several rare cancers. AstraZeneca will present EMERALD‑3 and POTOMAC data, pushing its Imfinzi‑based combos into first‑line...
Money, Patience, Intent—And Animal Models Drive Drug Discovery
After we showed that we can discover a drug in the UAE from scratch, many countries and their R&D organizations started reaching out with the offers "set up a site in our country and gain access to our wonderful population...
Single VERVE-102 Dose Slashes PCSK9 and LDL
we live in the future - the next step is designing large gene insertions and fine scale editing with AI 👀 @ProfluentBio “One dose of VERVE-102 (in vivo base editor) led to dose-dependent, substantial, and sustained reductions in PCSK9 and...
Oral Wegovy Backed by CHMP at May Meeting
The European Medicines Agency’s CHMP gave a positive opinion on Novo Nordisk’s oral formulation of Wegovy, marking the first EU approval for an oral GLP‑1 weight‑loss drug. The endorsement paves the way for a launch in select non‑US markets in...
Lilly's Verve Gene Editor Cuts Cholesterol, but Delays Loom
Eli Lilly $LLY says Verve’s gene editor lowers cholesterol levels in early, but development timelines have slipped. https://t.co/fuJOPyDwQb via @Jasonmmast
EU Opens Public Consultation on Biotech Act II, Targeting Industrial Fermentation and Biomanufacturing
The European Commission opened a public consultation on a proposed Biotech Act II, extending the EU’s biotech framework to cover industrial fermentation, cultivated biomass, and precision‑fermentation products. Stakeholders from alternative‑protein and industrial‑biotech firms submitted feedback urging clearer labeling, safety assessments, and...
FEATURE: From Lab Idea to $2.25 Billion: Ultrasound Destroys Cancer without Scalpels
Biomedical engineer Zhen Xu’s 25‑year effort produced histotripsy, an ultrasound‑based method that liquefies tumor cells without incisions. Her start‑up HistoSonics, founded in 2009, was valued at $2.25 billion after a majority‑stake investment. The technique earned FDA approval for liver cancer in...
Regeneron’s Melanoma Immunotherapy Misses Primary Endpoint, Shares Plunge
Regeneron Pharmaceuticals announced that its late‑stage melanoma trial combining the antibody fianlimab with PD‑1 inhibitor cemiplimab failed to meet its primary endpoint, prompting a double‑digit intraday share decline and prompting law‑firm investigations into prior disclosures. The setback raises questions about...
DNA Methylation Variability May Improve Precision Cancer Treatment Strategies
A new review in Genes & Diseases highlights DNA methylation heterogeneity as a driver of tumor microenvironment complexity. It distinguishes intra‑tumor and inter‑patient methylation variability and links these patterns to tumor evolution, immune escape, and metabolic reprogramming. Advances in quantitative...
Junshi Biosciences Wins China NMPA Approval for Loqtorzi HER2‑Urothelial Cancer Combo
Junshi Biosciences announced that China’s National Medical Products Administration has approved Loqtorzi, a toripalimab‑disitamab vedotin combo, for first‑line treatment of HER2‑expressing advanced urothelial carcinoma. The Phase III trial showed median progression‑free survival of 13.1 months and overall survival of 31.5 months, far outpacing...
Low-Dose Ketamine Shows Promise for Easing Chronic Fatigue
NIH researchers ran a randomized, double‑blind crossover trial with ten adults experiencing chronic fatigue from cancer, fibromyalgia, lupus and ME/CFS. A single low‑dose ketamine infusion lowered fatigue scores by 21% on day three, meeting the study’s 20% benchmark, while the...
Stem‑Cell Transplants Restore Insulin Production in Type 1 Diabetes, Early Trial Shows
Researchers reported that stem‑cell‑derived beta cell transplants restored measurable insulin production in a small cohort of Type 1 diabetes patients. The early results demonstrate that lab‑grown cells can survive, mature and function after implantation, offering a potential regenerative route for a...
Asundexian Cuts Recurrent Stroke Risk 26% Without Raising Bleeding in Global Phase 3 Trial
In the OCEANIC-STROKE Phase 3 trial, asundexian lowered recurrent stroke risk by 26% without elevating major bleeding rates, a result that could reshape secondary stroke prevention. The study enrolled 12,327 patients across 37 countries, comparing daily 50 mg asundexian to placebo...
NYU Langone mRNA Vaccine Cuts Melanoma Recurrence Risk by 49% in 5‑Year Study
NYU Langone Health’s Perlmutter Cancer Center reported that the personalized mRNA vaccine intismeran, when combined with pembrolizumab, lowered the five‑year risk of melanoma recurrence or death by 49% compared with pembrolizumab alone. The data, presented at ASCO and published in...
Cancer Immunotherapy Surge: Emerging Treatments and Future Outlook
I wrote about the remarkable proliferation of cancer immunotherapies, and what's in store https://t.co/od4MeFMGik https://t.co/5jI10LLbLq
UBS Lifts Jazz Pharma Price Target to $307, Upgrades to Buy
UBS analyst Ashwani Verma upgraded Jazz Pharmaceuticals (JAZZ) to Buy on May 19, raising the price target from $188 to $307 – a 63% jump that eclipses the prior consensus of $242. The move comes ahead of the August 25...
FDA Approves Datroway, First TROP2‑ADC for First‑Line Metastatic Triple‑Negative Breast Cancer
The U.S. FDA has approved Datroway (datopotamab deruxtecan‑dlnk), the first TROP2‑directed antibody‑drug conjugate for first‑line treatment of metastatic triple‑negative breast cancer in patients ineligible for PD‑1/PD‑L1 inhibitors. The approval follows a Phase 3 trial that demonstrated a median overall‑survival improvement of...
Kura Oncology’s SWOT Analysis: Biotech Stock Faces Launch Test
Kura Oncology secured FDA approval in November 2025 for Komzifti (ziftomenib) to treat relapsed or refractory NPM1‑mutated acute myeloid leukemia, propelling its stock nearly 100% higher over the past year. However, Q4 2025 sales fell short of analyst expectations, highlighting early‑launch...
Bispecifics in the Community: Infrastructure, Education, the Future
Bispecific antibodies are becoming a pivotal oncology therapy, delivering durable responses in relapsed or refractory hematologic cancers and moving into earlier treatment lines. Their step‑up dosing schedules and intensive toxicity monitoring demand new workflows, remote therapy monitoring, and robust coordination...