Latest FDA News | Page 3

American Gastroenterological Association invests in unsedated transnasal endoscopy medical device company, EvoEndo®
TGA review strengthens case for much tighter vape restrictions at the border
We’ve been connecting brains to computers longer than you’d expect. These 3 companies are leading the way
Chimeric Therapeutics reports ‘positive feedback’ on plan for CHM 2101
$7.5 million in grants for medical research
Interim analysis shows accuracy of Optiscan Imaging platform
FDA grants ‘orphan’ designation to PTX-100 for broader TCL indications
Update on US regulatory review of Lynparza in combination with abiraterone for metastatic castration-resistant prostate cancer
Update on effectiveness of monoclonal antibodies against COVID variants
Is there a vaccine for RSV or respiratory syncytial virus? After almost 60 years, several come at once
Weill Cornell Medicine grants to advance lymphoma research
Inhalable ‘SHIELD’ Protects Lungs Against Covid, Flu Viruses
Where did all diabetes drugs go?
AusBiotech advocates for sustainable funding model for TGA
Export success icing on cake for Dollar Sweets
FDA approves IND for Prader-Willi syndrome study of Neuren’s NNZ-2591
Dimerix confirms the outcomes of a meeting with the FDA on paediatric plan for DMX-200
New drug slowing Alzheimer’s disease progression approved in U.S
Artificial Intelligence in Veterinary Medicine Raises Ethical Challenges
CSL’s Novel Gene Therapy HEMGENIX Demonstrates Durable Protection and Sustained Factor IX Activity Levels for People Living
Comment from AGA: FDA actions on fecal microbiota therapy
CSL secures US approval for breakthrough one-time haemophilia gene therapy
U.S. Food and Drug Administration approves CSL’s HEMGENIX , first gene therapy for hemophilia B
IND approval from US FDA for theranostic SARBombesin trial in prostate cancer
PT027 recommended by FDA advisory committee as new rescue treatment for asthma
Telix announces positive topline results of late-stage imaging study
Veterans find relief from nightmares with NightWare and Apple Watch
Life sciences industry’s highest achievers celebrated at prestigious Awards ceremony
Linked databases aid long-term device surveillance
FDA submission triggers milestone payment for Neuren Pharmaceuticals
White House Holds Historic Conference on Hunger, Nutrition, and Health
Second fast-track designation for Australian immunotherapy company
Tezspire approved in Japan for treatment of severe asthma
Botanix Pharmaceuticals submits new drug application to FDA
Tezspire approved in EU for treatment of severe asthma
Monkeypox vaccine trial recruiting volunteers
Mosaic Brands pays penalties for alleged misleading representations about government approval of products
Imfinzi plus chemotherapy further improved overall survival benefit in advanced biliary tract cancer
Enhertu continues to demonstrate clinically meaningful tumour response
Imugene doses first patient in nextHERIZON Phase 2 clinical trial
Metabolomics Core Facility continues to expand while pushing scientific bounds
Optiscan Imaging submits 510 application to US FDA
Clinics win battle over meaning of 2016 FOIA amendments
AstraZeneca aims to transform cancer outcomes with new data across industry-leading portfolio at ESMO 2022
Lynparza in combination with abiraterone granted Priority Review in US for patients with metastatic castration-resistant prostate
Enhertu approved in US as first HER2-directed therapy for patients with previously treated HER2-mutant metastatic non-small cell
Mystery gene which helps mice survive virus infections
Enhertu approved in US as first HER2-directed therapy for patients with HER2-low metastatic breast cancer