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Federal Register notice: FDA updates its administrative records to reflect two Emergency Use Authorizations for biological product...[ Price : $8.95]
FDA says it is restricting the use of Intercepts Ocaliva in patients with primary biliary cholangitis and advanced cirrhosis of th...[ Price : $8.95]
In a sharply worded notice, FDA acting commissioner Janet Woodcock says the agency is reversing a Trump administration HHS notice ...[ Price : $8.95]
FDA puts a clinical hold on the Larimar Therapeutics clinical development program for CTI-1601 to treat Friedreichs ataxia.[ Price : $8.95]
FDA updates its guidance on Covid-19 EUAs to reflect that it may decline to review and process further EUA requests other than tho...[ Price : $8.95]
FDA tells Travere Therapeutics that data from the ongoing Phase 3 DUPLEX study of sparsentan for treating focal segmental glomerul...[ Price : $8.95]
FDA denies a Vifor Fresenius request for five-year NCE exclusivity for its Velphoro.[ Price : $8.95]
FDA and the FTC warn five companies they are marketing unapproved new drugs as dietary supplements to treat infertility.