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TXT FDA Clears Auris Health Robotic Surgery Device [158 Words] [ Price : $8.95]
FDA clears an Auris Health (Ethicon subsidiary) 510(k) for its Monarch surgery platform’s expansion to endourological procedures.
05/02/2022
 
 
TXT Marqibo Accelerated Approval Withdrawn [111 Words] [ Price : $8.95]
Federal Register notice: FDA withdraws the accelerated approval of Acrotech Biopharma’s NDA for Marqibo (vincristine sulfate liposome injection), indicated for treating certain adult patients with Philadelphia chromosome-negative acute lymphoblastic leukemia.
05/02/2022
 
 
TXT FDA Seeks ‘Quality Process Change’ in Toripalimab BLA [245 Words] [ Price : $8.95]
FDA issues a complete response letter to Shanghai Junshi Biosciences and Coherus BioSciences on their BLA for toripalimab in combination with gemcitabine and cisplatin in patients with advanced recurrent or metastatic nasopharyngeal carcinoma, requesting a “quality process change.”
05/02/2022
 
 
TXT IND Safety Reports eSubmission Guide [149 Words] [ Price : $8.95]
FDA posts a final guidance entitled Electronic Submission of IND Safety Reports Technical Conformance Guide.
05/02/2022
 
 
TXT CDRH Unveils Organizational Changes, New Offices [204 Words] [ Price : $8.95]
CDRH announces organizational changes that include new offices established within the Office of Product Evaluation and Quality.
05/02/2022
 
 
TXT FDA Hold on Vertex Cell Therapy for Diabetes [318 Words] [ Price : $8.95]
FDA places a clinical hold on a Vertex Pharmaceuticals Phase 1/2 clinical trial of VX-880, an investigational stem cell-derived, fully differentiated pancreatic islet cell replacement therapy for certain people with Type 1 diabetes.
05/02/2022
 
 
TXT Bakul Patel Leaving CDRH After 13 Years [243 Words] [ Price : $8.95]
After 13 years at the agency, CDRH Digital Health Center of Excellence director Bakul Patel announces he will be leaving the agency early this month to explore an undisclosed new chapter in his professional life.
05/02/2022
 
 
TXT Latest Federal Register Notices [3016 Words] [ Price : $8.95]
FDA Review posts the Federal Register notices for the week ending 4/29/2022.
05/01/2022
 
 
TXT FDA Puts Hold on Praxis Epilepsy Therapy [198 Words] [ Price : $8.95]
FDA sends an email to Praxis Precision Medicines that placed a clinical hold on PRAX-222, an antisense oligonucleotide for treating patients with SCN2A gain-of-function epilepsy.
04/29/2022
 
 
TXT FDA Warns on Medtronic Heartware Ventricular Assist Device [277 Words] [ Price : $8.95]
FDA warns healthcare providers about the possibility that patients who have Medtronic’s Heartware Ventricular Assist Device System and appear to present with pump thrombosis may instead have a welding defect in the device.
04/29/2022
 
 
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