By the end of March, the agency could approve multiple “national priority” voucher winners, as well as a gene therapy it ...
In this part 3 of our three-part interview, Stenberg explores the evolving manufacturing paradigm in the pharmaceutical ...
The Food and Drug Administration has approved Novo Nordisk’s once-daily Wegovy pill, the first oral GLP-1 medicine for ...
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FDA issues CRL to SNY's regulatory filing for multiple sclerosis drug
Sanofi SNY announced that the FDA has issued a complete response letter (CRL) to its new drug application (NDA), seeking approval for its investigational Bruton's tyrosine kinase (BTK) inhibitor, ...
CEO Sean Nolan stated, “The recent regulatory clarity and progress we've achieved, which was enabled by the strength of our REVEAL Part A data set, rigorous data evaluation methodology, and our ...
Larimar Therapeutics, Inc. has announced a refined timeline for submitting a Biologics License Application (BLA) for its treatment nomlabofusp, aimed at addressing Friedreich's Ataxia (FA). Based on ...
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