Latest FDA News

Ketamine’s role in alleged Cornell rape highlights flood of psychoactive drugs on campus
That brightly packaged sexual enhancement pill at the gas station might be laced with dangerous drugs
Nicotine pouches, vaping or cigarettes: Which nicotine product is actually the least harmful?
NeuroScientific secures FDA support for Crohn’s trial design ahead of US submission
How bionic eyes are becoming a reality
Efzimfotase alfa showed numerical improvement in Six-Minute Walk Test achieving mean difference of 17.05 metres vs placebo in treatment-naïve adolescents and adults…
Flu season is near – here’s a guide to available vaccines
ComplianceQuest and Zolon PCS Selected to Modernize U.S. Food and Drug Administration (FDA) Enterprise Quality Management System
Currus Biologics announces FDA IND clearance for Phase 1 trial of CUR-001 in mesothelin-positive advanced refractory solid tumours
Perioperative Imfinzi plus neoadjuvant enfortumab vedotin granted Priority Review in the US for patients with muscle-invasive bladder cancer
At-home drug disposal products can play an important role in keeping rural Coloradans safe
Efzimfotase alfa granted Priority Review in the US as treatment for patients with hypophosphatasia aged 2 years and older
Dr Tass Warns Peptide Enthusiasm Has Outpaced Evidence
Lenire launches in Australia to address a growing tinnitus crisis affecting one in four workers
Tozorakimab demonstrated statistically significant and highly clinically meaningful reduction in COPD exacerbations in OBERON and TITANIA Phase III trials
Etcamah in combination with a CDK4/6 inhibitor approved in the US for 1st-line advanced HR-positive breast cancer
Experimental brain implants are on the rise. What happens after the trials are over?
AstraZeneca completes global license agreement for oral EGFR inhibitor Zegfrovy for lung cancer
FDA approves breakthrough pancreatic cancer drug – an oncologist explains how daraxonrasib nearly doubles survival
US teens are smoking and vaping less than their peers abroad
DIY peptide injections are risky, and people may make serious mistakes when administering them
First mRNA flu shot approved by FDA bodes well for improving drugs of the future – though a few hurdles remain before…
BlinkLab (ASX:BB1) Commences Pivotal FDA Study for Smartphone AI Autism Diagnostic
Aravax Awarded FDA Fast Track Designation for PVX108, a Next-Generation Immunotherapy for the Treatment of Peanut Allergy
Flawed studies linking hormone therapy to breast cancer made doctors reluctant to prescribe it for menopause relief – especially for breast cancer survivors
AI in healthcare is an evolving landscape of new technologies, productivity benefits and legal uncertainties
Update on Phase III trial of Ultomiris in adults and adolescents with thrombotic microangiopathy after haematopoietic stem cell transplant
Trixeo recommended for approval in the EU by CHMP for the maintenance treatment of asthma
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