Latest FDA News

FDA drug approval affects healthcare around the world, but political shortcuts could hurt the agency’s international reputation
AstraZeneca enters exclusive global license agreement for novel oral EGFR inhibitor Zegfrovy for lung cancer with Dizal Pharmaceutical
There’s one reason why so many cold and flu tablets don’t actually work
Stroke test tech receives ‘breakthrough’ status from FDA
First new US sunscreen ingredient since 1999 approved by FDA – a skin scientist explains how bemotrizinol works
Ultomiris granted Priority Review in the US as treatment for adults with immunoglobulin A nephropathy
Truqap combination approved in the US as first and only targeted treatment for PTEN-deficient metastatic hormone-sensitive prostate cancer
CARES Phase III clinical programme did not meet primary endpoint in overall light chain amyloidosis population, however, demonstrated anselamimab as potential first…
US FDA decision date extended for SERENA-6 filing of camizestrant to enable review of additional data
AstraZeneca to showcase Phase III data in liver, breast and bladder cancers and potential first-in-class rare disease therapy at ASCO 2026
Enhertu approved in the US for two new indications for patients with HER2-positive early breast cancer
Supreme Court preserves access to mifepristone via telehealth – at least for now
Sweet: the quest for a sugar alternative
Truqap recommended by FDA Advisory Committee for PTEN-deficient metastatic hormone-sensitive prostate cancer
Update on FDA Advisory Committee vote on camizestrant in combination with a CDK4/6 inhibitor for advanced HR-positive breast cancer
Breztri approved in the US for asthma as first and only triple therapy for patients 12 years of age and older
Saphnelo approved in the US for subcutaneous self-administration as a new autoinjector for the treatment of systemic lupus erythematosus
Massive eye drop recall reflects ongoing issues with manufacturing and FDA inspection
Perth MedTech BlinkLab (ASX:BB1) Commences Pivotal FDA Study for Smartphone AI Autism Diagnostic
Fast, Affordable Autism Diagnosis Could be on The Way With The Help of an Australian AI Start Up BlinkLab and The Moroccan Government
Magic mushroom-infused products appear in Colorado gas stations – what public health officials want consumers to know
BlinkLab Limited (ASX:BB1) Completes Clinical Trial Network for Pivotal FDA Study with Tenth U.S. Site Onboarded
Enhertu granted Priority Review in the US as post-neoadjuvant treatment for patients with HER2-positive early breast cancer
Are mental health apps like doctors, yogis, drugs or supplements?
Drug company ads are easy to blame for misleading patients and raising costs, but research shows they do help patients get needed treatment
UNSW Sydney takes lion’s share of cardiovascular research awards
Anthony Rodgers takes out top NSW state award for cardiovascular research award
Menstrual pads and tampons can contain toxic substances – here’s what to know about this emerging health issue
FDA’s abrupt flip-flop on Moderna’s mRNA flu shot highlights growing risks to drug-makers of investing in vaccines
Federal Budget 2026-27: AFSA calls for $5m pilot to validate animal-free methods and improve health research translation
Update on US regulatory review of Saphnelo subcutaneous administration in systemic lupus erythematosus
Datroway granted Priority Review in the US as 1st-line treatment for patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy
Kyowa Kirin to Regain Control of Rocatinlimab Development and Commercialization Program, Demonstrating Strong Commitment to Address High Unmet Medical Need in Atopic Dermatitis
Should medical marijuana be less stringently regulated? A drug policy expert explains what’s at stake
BlinkLab Receives $822,205 R&D Tax Incentive Refund Relating to Autism Diagnostic Tool Pilot Study and Clinical Research Initiatives
Nexsen advances U.S. market entry with FDA engagement for GBS rapid sensor whilst strengthening leadership team
FDA claims on COVID-19 vaccine safety are unsupported by reliable data – and could severely hinder vaccine access
US-approved drug to improve quality of life for people with rare conditionn
Off-label use of COVID-19 vaccines was once discouraged but has become common amid new guidelines
FDA recall of blood pressure pills due to cancer-causing contaminant may point to higher safety risks in older generic drugs
Brewery waste can be repurposed to make nanoparticles that can fight bacteria
Atorvastatin recall may affect hundreds of thousands of patients – and reflects FDA’s troubles inspecting medicines manufactured overseas
16th Annual Meeting of the WHO International Regulatory Cooperation for Herbal Medicines (IRCH)
Digital health is changing – here’s what it means for Australians
Bird Flu Persists In Raw Milk Cheese
Conflict At Counter: When Pharmacists’ And Patients’ Values Collide
Science Costs Money – Research Is Guided By Who Funds It And Why
Deadly Pathogens Found In Commercial Raw Cat Foods