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Latest FDA News

Exploring bacopa: the science behind the latest brain health trend
Stricter abortion laws may cause increased infant deaths − 2 maternal and child health researchers explain the data
Health and Human Services secretary influences every aspect of America’s health
FDA bans Red 3 dye from food and drugs – a scientist explains the artificial color’s health risks and long history
GLP-1 drugs may reduce surgery complications in patients with diabetes
Will AI revolutionize drug development? Researchers explain why it depends on how it’s used
Vaccine misinformation distorts science – a biochemist explains how RFK Jr. and his lawyer’s claims threaten public health
HistoSonics Edison® Histotripsy System Treats First Pancreatic Tumor Patients in GANNON Trial
Galderma Receives U.S. FDA Approval for Nemluvio® (Nemolizumab) for Patients with Moderate-to-Severe Atopic Dermatitis
CHMP Recommends Approval of Galderma’s Nemolizumab for Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis in the European Union
FivepHusion secures ethics approval of a Phase 1b deflexifol clinical trial
NEXSEN Biotech Announces Pre-IPO Fundraising to Revolutionise Point-of-Care Diagnostics
Avian flu virus has been found in raw milk − a reminder of how pasteurization protects health
Orthocell says it has achieved all endpoints in pivotal of nerve repair product
Tirzepatide shows strong diabetes-prevention effect in trial
GE HealthCare to Acquire Remaining 50% Stake in Nihon Medi-Physics (NMP), a Leading Radiopharmaceutical Company in Japan, from Sumitomo Chemical
Cinnamon, spice and ‘everything nice’ – why lead-tainted cinnamon products have turned up on shelves, and what questions consumers should ask
A common nasal decongestant lacks evidence but is still sold in the UK
Transplanting insulin-making cells to treat Type 1 diabetes is challenging − but stem cells offer a potential improvement
QIMR Berghofer research leads to new treatment for potentially deadly Graft-versus-Host Disease
HistoSonics® Enrolls First Patients in Company’s Novel BOOMBOX Master Study
Data Sharing Is Patient Caring
What a Trump presidency means for global health
Imugene says bile tract cancer patient maintains complete response in MAST study
Grant to help develop portable PET scanner for Alzheimer’s
Medidata Launches Bundled Solutions to Support Oncology and Vaccine Trials, Accelerating Study Design and Execution
First Site Initiated in Australia for MannKind’s Phase 3 Clinical Trial Evaluating Clofazimine Inhalation Suspension for the Treatment of Nontuberculous Mycobacterial (NTM) Lung Disease
US FDA Accepts Biologics License Application (BLA) for HLX14, Biosimilar Candidate of PROLIA/XGEVA (denosumab)
PolyActiva Showcases Promising Clinical Data Highlighting its Polymer Technology’s Potential to Transform Glaucoma Care
Snow probes adapted to improve pharmaceutical manufacturing
Seaport Therapeutics secures US$225 Series B funding to develop neuropsychiatric medicines using Monash University prodrug technology
FDA commissioner in talk urges Cornell community to focus on US health
DEA could reclassify marijuana to a less restrictive category – a drug policy expert weighs the pros and cons
Buyer beware: Off-brand Ozempic, Zepbound and other weight loss products carry undisclosed risks for consumers
Chimeric says cancer patient achieves complete response in CHM CORE-NK trial
FDA approves OTC hearing aid software; know the potential limitations
Distinguished Oncologist, Professor Daniel Von Hoff joins the Scientific/Clinical Advisory Board of EnGeneIC Cancer Therapeutics
Mesoblast option to issue up to US$50 million convertible notes for product launch
Percheron Therapeutics updates on Avicursen primate toxicology study
Nanoscope Therapeutics Licenses Optogenetic Technology
Argenica reports positive results in IND-enabling trials
Fujirebio Submits FDA Regulatory Filing for Lumipulse® G pTau 217/ß-Amyloid 1-42 Plasma Ratio In-Vitro Diagnostic Test as an Aid to Identify Patients…
TRUTH in Labeling Act would heighten the warning for shoppers looking to cut sugar, salt and saturated fat intake
Organon to Acquire Dermavant including its Innovative Dermatologic Therapy, VTAMA® (tapinarof) Cream, 1%
PharmAust says EMA pre-submission meeting paves the way for orphan designation request
MRM Health Appoints Grégoire Franoux as Chief Business Officer and Adds Ron Robison to its Board of Directors
New COVID vaccines may be coming to Australia. Here’s what to know about the JN.1 shots
Apple Watch Ultra 2 Now Available In Black Titanium