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  • Latest FDA news stories and updates. What is happening today? All recent FDA news and developments. Live coverage and timeline of FDA. All you need to know about FDA.
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
Radiopharm Theranostics announces new agreements with Lantheus and NanoMab
ATAGI recommendations on Covid vaccine use in children aged 6 months
What allegations of Alzheimer’s research fraud mean for patients
Critical oncology trial data remains hidden
Researchers design new hydrogel for more targeted cancer treatments
Genetic Signatures completes recruitment in pivotal clinical trial
Immuron provides update on FDA review of IND application
Adherium wins US clearance for GSK inhaler users to connect to new platform
Tezspire recommended for approval in EU by CHMP for treatment of severe asthma
Enhertu granted Priority Review in US for patients with HER2-low metastatic breast cancer
Virgin Atlantic, Corendon Dutch Airlines and Albawings Adopt Boeing’s Digital Sustainability Solutions
Botanix Pharmaceuticals accelerates filing of NDA
Home use fetal dopplers
Lumos Diagnostics secures authorisation for test in Canada
AGA issues clinical guidelines outlining drug treatment plans for patients with irritable bowel syndrome
New orphan drug designation for Kazia Therapeutics’ paxalisib
ATAGI recommendations on first booster dose in adolescents aged 12
Clarity secures US IND approval for phase 2 prostate cancer trial
BioCina: Developing technologies to support next generation of mRNA-based therapies
Adherium provides update on senior management
AstraZeneca aims to transform cancer care with practice-changing data at ASCO 2022
FDA confirms diagnostic method for Medibio’s final depression validation trial
Insight – US to temporarily reduce regulatory barriers for infant formula imports
Immuron partner submits IND application to US FDA for new therapeutic
Product information update for Covid treatment, XEVUDY
Enhertu approved in US for patients with HER2-positive metastatic breast cancer treated with prior anti-HER2-based regimen
New senior appointments for Tessara Therapeutics
Botanix acquires rights to new dermatology product

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