Feb 26, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) approved Amondys 45 (casimersen) injection from Sarepta Therapeutics for the treatment of Duchenne muscular dystrophy (DMD) in patients that have a mutation amenable to skipping exon 45. DMD is a genetic disorder that causes... 
Feb 25, 2021 | News, Regulatory
The Center for Biologics Evaluation and Research (CBER), part of the U.S. Food and Drug Administration (FDA), partially rescinded two approvals of supplemental biologics license applications (sBLAs) for recombinant factor IX products. The sBLAs were approved by the... 
Feb 24, 2021 | News, Regulatory
Sinopharm, a unit of the China National Pharmaceutical Group, and CanSinoBiologics Inc both have applied in China for the public use of their COVID-19 vaccines. Currently, China has two approved vaccines that were developed within the country, and has yet to approve... 
Feb 23, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) has revealed recommendations for drug developers and diagnostic test makers to address the efficacy and overall performance of their products in consideration of the COVID-19 variants. The updates in recommendations are... 
Feb 18, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) has granted Novartis’ Entresto expanded indication for chronic heart failure, making it the only drug therapy approved in the US to treat patients afflicted with guideline-defined heart failure. Approximately 83% of...
