Blog
RSS FeedPosted by Michael Wonder on 23 Apr 2021
FDA grants accelerated approval to loncastuximab tesirine-lpyl for large B-cell lymphoma
23 April 2021 - Today the FDA granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta, ADC Therapeutics), a CD19-directed antibody and alkylating ...
Posted by Michael Wonder on 23 Apr 2021
Roche receives FDA approval for first companion diagnostic to identify endometrial cancer patients eligible for immunotherapy
23 April 2021 - VENTANA MMR RxDx Panel is the first immunohistochemistry predictive test in endometrial cancer for treatment with the ...
Posted by Michael Wonder on 22 Apr 2021
FDA approves immunotherapy for endometrial cancer with specific biomarker
22 April 2021 - Today, the U.S. FDA granted accelerated approval to Jemperli (dostarlimab) for treating patients with recurrent or advanced ...
Posted by Michael Wonder on 22 Apr 2021
Allogene Therapeutics announces FDA regenerative medicine advanced therapy designation granted to ALLO-715, an AlloCAR T cell therapy in development for relapsed/refractory multiple myeloma
21 April 2021 - Regenerative medicine advanced therapy designation follows proof of concept data from ALLO-715 UNIVERSAL trial in heavily pretreated, ...
Posted by Michael Wonder on 21 Apr 2021
“Dangling” accelerated approvals in oncology
21 April 2021 - The FDA recently reevaluated accelerated approvals for 35 oncology indications for anti–programmed death ligand 1 antibodies, revealing ...
Posted by Michael Wonder on 21 Apr 2021
FDA continues important steps to ensure quality, safety and effectiveness of authorised COVID-19 vaccines
21 April 2021 - The U.S. FDA takes its responsibility to ensure medical product quality, safety and effectiveness very seriously. ...
Posted by Michael Wonder on 21 Apr 2021
Medtronic receives U.S. FDA approval for pipeline flex embolisation device with shield technology
21 April 2021 - First patient receives new shield surface modification, an advance in flow diversion therapy, at NYU Langone Health. ...
Posted by Michael Wonder on 21 Apr 2021
FDA: make medical apps reliable, not risky
21 April 2021 - The fear of Covid-19 catapulted symptom checkers from the periphery of public attention to the center. ...
Posted by Michael Wonder on 20 Apr 2021
Amgen launches Biomarker Assist, a program to help more patients with non-small cell lung cancer gain access to biomarker testing
19 April 2021 - Half of all patients with non-small cell lung cancer have oncogene mutations, yet many patients are not ...
Posted by Michael Wonder on 20 Apr 2021
Biocartis announces US FDA 510(k) submission of its Idylla MSI test
20 April 2021 - First US FDA oncology assay submission for Biocartis. ...
Posted by Michael Wonder on 20 Apr 2021
LEXEO Therapeutics announces FDA fast track designation granted to LX1001 for the treatment of APOE4 associated Alzheimer’s disease
20 April 2021 - LX1001 is the first investigational gene therapy being evaluated to address the underlying genetics of Alzheimer’s disease. ...
Posted by Michael Wonder on 20 Apr 2021
Alnylam submits new drug application with U.S. FDA for vutrisiran for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults
19 April 2021 - Alnylam has submitted a new drug application to the U.S. FDA for the approval of vutrisiran for ...
Posted by Michael Wonder on 20 Apr 2021
Amgen's investigational targeted treatment bemarituzumab granted breakthrough therapy designation
19 April 2021 - Designation is supported by results from the Phase 2 FIGHT trial. ...
Posted by Michael Wonder on 19 Apr 2021
FDA issues final rule removing certain software from medical device regulations
19 April 2021 - The US FDA has issued a final rule making that eliminates certain software intended to transfer, ...
Posted by Michael Wonder on 19 Apr 2021
Fauci says he expects a decision Friday on whether the U.S. can resume using Johnson & Johnson’s vaccine
18 April 2021 - A decision about whether to resume administering the Johnson & Johnson COVID-19 vaccine should come this ...