The FDA granted priority review to a new drug application for sunvozertinib as an oral treatment for certain patients with ...
Agios Pharmaceuticals, Inc. (AGIO), on Wednesday, announced that its supplemental New Drug Application seeking approval for the ...
Solid Biosciences received clearance from the Food and Drug Administration for an investigational new drug application, the company said Tuesday.
Denali Therapeutics Inc. (NASDAQ: DNLI), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tividenofusp alfa (DNL310) for the treatment ...
Shares of Solid Biosciences (NASDAQ:SLDB) jumped 11% post-market after the company said the FDA had cleared an ...
On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for ...
Sentynl took over the therapy’s development and commercialisation from Fortress Biotech's subsidiary Cyprium Therapeutics.
Dr. Anil Diwan, President of NanoViricides, Inc. (NYSE American: NNVC) (the “Company”), comments on the many viruses that could cause pandemics that are going around already.
Artificial intelligence (AI) is transforming the health care landscape, from diagnostics to drug development and clinical trials. As AI ...
Clinical Trial Application for global Phase 3 trials with nizubaglustat in GM1/GM2 gangliosidoses and Niemann-Pick Disease ...
Yet the long-term growth potential of healthcare can’t be ignored — the sector accounts for 10.2% of global GDP and with the global GDP projected to reach $137 trillion by 2030, there will be some $14 ...
According to the FDA, 1 each of the unapproved products were sold on the firm’s websites, Amazon shops, and social media ...