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Sanofi says it will not seek FDA approval for tolebrutinib in primary progressive multiple sclerosis after the drug failed to meet...[ Price : $8.95]
FDA says it is removing a long-standing barrier to the use of real-world evidence in regulatory reviews by accepting such data wit...[ Price : $8.95]
FDA posts two final guidances that provide recommendations to help clinical investigators comply with the safety reporting require...[ Price : $8.95]
The Government Accountability Office urges HHS to shore up staffing and reassess legal authorities at FDA after finding significan...[ Price : $8.95]
FDA approves Daiichi Sankyos Enhertu (fam-trastuzumab deruxtecan-nxki) in combination with Genentechs pertuzumab as a first-line t...[ Price : $8.95]
FDA posts updated guidance calling on drug and biologics developers to broaden eligibility criteria, modernize enrollment practice...[ Price : $8.95]
FDA considers adding a Boxed Warning to Covid-19 vaccines, the latest action as part of an ongoing campaign to scrutinize and rest...[ Price : $8.95]
FDA approves Amgens Uplizna (inebilizumab-cdon) for adults with generalized myasthenia gravis who test positive for anti-acetylcho...