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Marqibo Accelerated Approval Withdrawn
[111 Words]
[ Price : $8.95]
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| 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. |
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05/02/2022
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FDA Seeks ‘Quality Process Change’ in Toripalimab BLA
[245 Words]
[ Price : $8.95]
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| 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.” |
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05/02/2022
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IND Safety Reports eSubmission Guide
[149 Words]
[ Price : $8.95]
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| FDA posts a final guidance entitled Electronic Submission of IND Safety Reports Technical Conformance Guide. |
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05/02/2022
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FDA Hold on Vertex Cell Therapy for Diabetes
[318 Words]
[ Price : $8.95]
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| 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. |
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05/02/2022
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Bakul Patel Leaving CDRH After 13 Years
[243 Words]
[ Price : $8.95]
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| 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. |
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05/02/2022
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FDA Puts Hold on Praxis Epilepsy Therapy
[198 Words]
[ Price : $8.95]
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| 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. |
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04/29/2022
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FDA Warns on Medtronic Heartware Ventricular Assist Device
[277 Words]
[ Price : $8.95]
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| 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. |
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04/29/2022
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