Drug approvals, biotechnology, clinical evidence and healthcare innovation. We report on confirmed regulatory decisions and peer-reviewed research.
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The FDA approved Tregzi, a donor-derived cellular immunotherapy for adults with blood cancers undergoing allogeneic stem-cell transplantation.
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The FDA selected seven companies for a pilot intended to bring earlier regulatory engagement to new U.S. pharmaceutical manufacturing facilities.
The FDA updated its clinical decision support software FAQ, clarifying how software functions may fall outside device regulation, receive enforcement discretion or remain subject to oversight.
UCLA researchers linked long-term chlorpyrifos exposure to a sharply higher Parkinson's disease risk and described a mechanism involving dopamine neurons and impaired cellular cleanup.
City of Hope and UCLA researchers identified age-specific adipose progenitor cells that may help explain why abdominal fat increases in middle age.
A pilot translational study found that nitrosylcobalamin crossed the blood-brain barrier, accumulated in glioblastoma tissue and strengthened the effect of existing treatments in lab models.
Aidoc says the FDA granted Breakthrough Device Designation to First Read, an investigational AI system that analyzes chest X-rays and drafts preliminary radiology report text.
Two Nature studies on MIRA and Google's AMIE test whether medical AI agents can reason across history-taking, investigations, guidelines and treatment planning.
The 2026 AI Index medicine chapter highlights smaller biological models, virtual-cell systems, clinical-note automation and the data limits shaping medical AI.
Recent Nature-linked work on RNA splicing prediction shows how AI is being pulled into variant interpretation, cancer biology and tissue-specific transcript analysis.
The FDA listed June 24 approvals for sacituzumab govitecan in triple-negative breast cancer and palbociclib maintenance therapy in HR-positive, HER2-positive metastatic breast cancer.
Researchers reported an experimental compound that targets GRK2-linked cellular damage and showed protective effects in mouse models of Alzheimer disease.
OpenAI says GPT-5 Pro helped immunologist Derya Unutmaz revisit a stalled T-cell experiment and identify a plausible mechanism involving IL-2 and Th17 cell differentiation.
University of Calgary researchers are testing controlled-release niacin alongside standard glioblastoma treatment, with early Phase I/II results suggesting immune-cell effects and better-than-expected six-month disease control.
A University of New South Wales-led review concludes that nicotine vaping is likely to cause lung and oral cancers, drawing on human biomarkers, animal work and laboratory evidence.
The FDA added a final guidance telling sponsors how to submit clinical-study datasets that evaluate immunogenicity and its impact on drug pharmacokinetics.
The FDA approved the first generic version of Xofluza, baloxavir marboxil tablets, for acute uncomplicated influenza treatment and post-exposure prophylaxis in patients aged five and older.
ScienceDaily reported early-stage research on a biomaterial combining jackfruit latex, pomegranate peel and simvastatin that may help address infection, inflammation and tissue loss in severe gum disease models.
The FDA approved tebipenem pivoxil tablets for adults with complicated urinary tract infections who have limited or no alternative oral treatment options.
The 4 mg intranasal naloxone product can be sold directly to consumers without a prescription, adding another nonprescription option for emergency opioid-overdose reversal.
The SOLSTICE trial found that elecoglipron, an oral small-molecule GLP-1 receptor agonist, lowered glucose and weight in adults with type 2 diabetes, with results presented at ADA and published in The Lancet.
People who reversed prediabetes showed substantially lower long-term cardiovascular risk in analyses of two landmark diabetes-prevention cohorts.
ENDO 2026 research using All of Us and Fitbit data found daily steps and moderate-to-vigorous activity fell after adults with obesity began GLP-1 medications.
NHS England urged the public to keep using urgent and emergency services as resident doctors prepared for industrial action during hot weather and the opening week of the football World Cup.
The clearance expands Dexcom's Stelo Glucose Biosensor System to users aged two and older who do not use insulin, while FDA warns it is not designed for problematic hypoglycemia alerts.
The FDA approved belzutifan plus pembrolizumab as adjuvant treatment for certain clear cell renal cell carcinoma patients at elevated risk of recurrence after nephrectomy, with overall-survival data still immature.
The UK regulator has authorised a 1 mg EURneffy nasal spray for children aged four and over who weigh 15 kg to 30 kg, extending needle-free emergency anaphylaxis treatment to a younger group.
Researchers describe a graph neural network model trained on ICU time-series data that can predict clinical deterioration earlier than conventional scoring systems, with potential implications for resource allocation and early intervention.
A study describes an AI system for predicting readiness for ventilator weaning that provides feature-level explanations alongside its predictions, aiming to support rather than replace clinical judgement at a high-stakes decision point.
The UK medicines regulator released findings from public engagement that will feed into the AI Commission and future healthcare AI rules.
The MHRA approved an oral semaglutide tablet for weight loss and weight management, widening the GLP-1 market beyond weekly injections.
A new UK government funding package will extend AI-supported chest X-ray analysis to every NHS trust in England by 2029, while backing new digital trials across heart failure, stroke, lung cancer and other conditions.
Google DeepMind has extended AlphaFold 3 to predict the structure of complexes involving small molecules, DNA, RNA and modified residues, moving the tool closer to practical use in early-stage pharmaceutical research.
The World Health Organization has released guidance for governments and health authorities on establishing governance structures for AI in healthcare, covering procurement, evaluation, post-deployment monitoring and equity considerations.
The National Institute for Health and Care Excellence has published a framework for assessing AI-powered clinical decision support tools, setting out the evidence standards it expects before recommending such technologies for NHS use.
The ultraviolet filter has been used internationally for years and can now be included in qualifying US over-the-counter sunscreens at concentrations of up to 6%.
The antibody-drug conjugate targets CD123 in adults with blastic plasmacytoid dendritic cell neoplasm, a rare and aggressive hematologic malignancy.
The FDA approved datopotamab deruxtecan-dlnk for adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1 or PD-L1 inhibitor therapy.
The FDA approved fam-trastuzumab deruxtecan-nxki for two HER2-positive early-stage breast cancer settings, covering neoadjuvant use and adjuvant treatment after residual disease.
The FDA approved zenocutuzumab-zbco for adults with advanced, unresectable or metastatic cholangiocarcinoma harbouring an NRG1 gene fusion after prior systemic therapy.
The FDA approved vepdegestrant for certain adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after endocrine therapy.
FDA began a pilot aimed at using cloud and AI tools to support real-time clinical drug trials and reduce development timelines.
The FDA opened a pilot intended to connect selected digital health devices with chronic-care payment innovation while keeping safety and evidence questions visible.
WHO/Europe said its report offered a first cross-country view of how EU member states are approaching AI in health care.
Atlantic Health’s Humanistic Medicine Symposium examined bioethical questions around AI in clinical decision-making.
The UK medicines regulator said new funding would expand the AI Airlock programme, its controlled testing route for AI as a medical device.
FDA approved orforglipron as the first new molecular entity cleared under the Commissioner’s National Priority Voucher pilot.
The FDA approved relacorilant with nab-paclitaxel for certain adults with platinum-resistant ovarian, fallopian tube or primary peritoneal cancer after prior systemic treatment.
The FDA approved nivolumab with doxorubicin, vinblastine and dacarbazine for adults and pediatric patients 12 and older with previously untreated stage III or IV classical Hodgkin lymphoma.
A European trial reported that sulthiame reduced breathing interruptions in people with moderate to severe obstructive sleep apnea, including dose-dependent improvements.
The FDA approved teclistamab with daratumumab hyaluronidase for adults with relapsed or refractory multiple myeloma after at least one prior line of therapy.
The FDA granted accelerated approval to zongertinib for adults with unresectable or metastatic non-squamous NSCLC with HER2 tyrosine kinase domain activating mutations.
The FDA approved acalabrutinib tablets and capsules with venetoclax for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma.
The FDA approved pembrolizumab, including the Qlex formulation, with paclitaxel with or without bevacizumab for certain PD-L1-positive ovarian, fallopian tube or primary peritoneal cancers.
FDA said it intends to restrict GLP-1 active pharmaceutical ingredients used in mass-marketed compounded alternatives to approved obesity and diabetes drugs.
FDA approved daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide and dexamethasone for transplant-ineligible newly diagnosed multiple myeloma.
FDA’s Human Foods Program listed 2026 priority deliverables across food chemical safety, nutrition and microbiological safety.
FDA approved Zycubo as the first treatment for pediatric patients with Menkes disease.
HHS/CDC accepted recommendations changing childhood immunization practices, prompting scrutiny from health-policy observers.
Tradipitant gained FDA approval as a new medicine for prevention of vomiting associated with motion sickness.
FDA approved Accrufer capsules for pediatric patients ages 10 and older with iron deficiency.
FDA approved amivantamab and hyaluronidase-lpuj for subcutaneous injection across indications already approved for intravenous amivantamab.
FDA approved Akeega with prednisone for adults with BRCA2-mutated metastatic castration-sensitive prostate cancer.
FDA granted traditional approval to pirtobrutinib for adults with relapsed or refractory CLL/SLL after prior BTK inhibitor treatment.
FDA approved durvalumab with FLOT chemotherapy as neoadjuvant and adjuvant treatment for adults with resectable gastric or gastroesophageal junction adenocarcinoma.
FDA approved pembrolizumab or its subcutaneous formulation with enfortumab vedotin as perioperative treatment for cisplatin-ineligible muscle-invasive bladder cancer.
FDA approved ziftomenib for adults with relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation.
FDA approved daratumumab and hyaluronidase-fihj for adults with high-risk smoldering multiple myeloma.
The Universal AI for Health Summit brought health, technology and policy leaders together around practical AI implementation in care settings.
FDA approved belantamab mafodotin-blmf with bortezomib and dexamethasone for relapsed or refractory multiple myeloma.
A JAMA special communication summarised how health AI should be developed, evaluated, regulated, disseminated and monitored.
FDA approved cemiplimab-rwlc for adjuvant treatment of adults with cutaneous squamous cell carcinoma at high risk of recurrence.
FDA requested public comment on practical approaches for measuring and evaluating AI-enabled medical-device performance after deployment.
FDA approved imlunestrant for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after endocrine therapy.
FDA approved Keytruda Qlex for subcutaneous injection across adult and pediatric solid-tumor indications approved for intravenous pembrolizumab.
FDA approved Inlexzo for adults with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors.
FDA issued new principles intended to support rare-disease drug development where small populations and limited natural-history data complicate traditional evidence generation.
FDA granted accelerated approval to zongertinib for adults with previously treated unresectable or metastatic non-squamous NSCLC with HER2 tyrosine kinase domain activating mutations.
Dordaviprone received accelerated approval for adults and children with progressive H3 K27M-mutant diffuse midline glioma after prior therapy.
WHO published a technical brief on how artificial intelligence could be used in traditional medicine, from knowledge mapping to safety and governance.
FDA granted accelerated approval to sunvozertinib for adults with previously treated EGFR exon 20 insertion-mutated non-small cell lung cancer.
FDA granted accelerated approval to linvoseltamab for adults with relapsed or refractory multiple myeloma after at least four prior therapy lines.
The FDA approved pembrolizumab on 12 June 2025 for adults with resectable locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1.
On 12 June 2025, FDA approved mitomycin intravesical solution for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
On 11 June 2025, the FDA approved taletrectinib for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer.
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