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TXT FDA Priority Review for Merck Keytruda sBLA [226 Words] [ Price : $8.95]
FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), its anti-PD-1 therapy as monotherapy or in combination with platinum and 5-fluorouracil chemotherapy for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma.
02/11/2019
 
 
TXT Regulatory Review Period for Sarepta’s Duchenne Drug [67 Words] [ Price : $8.95]
Federal Register notice: FDA has determined that the regulatory review period for Sarepta’s Duchenne drug Exondys 51 (eteplirsen).
02/11/2019
 
 
TXT New Efforts Mulled to Modernize Dietary Supplement Regulation [503 Words] [ Price : $8.95]
FDA says it is working on a new plan to modernize dietary supplement regulation and oversight.
02/11/2019
 
 
TXT OCI Lends Support in Drug Compounding Kickback Scheme [172 Words] [ Price : $8.95]
FDA’s Office of Criminal Investigations helps investigate a case where a Texas marketer agreed to pay the government $339,413 for allegedly accepting illegal kickback payments from OK Compounding.
02/11/2019
 
 
TXT Workshop on Boosting Patient Perspectives on Clinical Trials [99 Words] [ Price : $8.95]
Federal Register notice: FDA announces a 3/18 workshop entitled “Enhancing the Incorporation of Patient Perspectives on Clinical Trials,” which is being convened by the ongoing Clinical Trials Transformation Initiative.
02/11/2019
 
 
TXT ANDA Summary Tables Updated [154 Words] [ Price : $8.95]
FDA updates summary table forms for ANDA submissions containing clinical endpoint studies.
02/11/2019
 
 
TXT BioDirection Gains Breakthrough Designation for Tbit System [142 Words] [ Price : $8.95]
FDA grants BioDirection a breakthrough device designation for its Tbit System for the prediction of positive computerized tomography scans following a traumatic brain injury.
02/11/2019
 
 
TXT FDA Targets 17 Online Unapproved Product Marketers [111 Words] [ Price : $8.95]
FDA issues 12 Warning Letters and 5 online advisory letters to companies that are “illegally” selling more than 58 products that are unapproved or misbranded drugs.
02/11/2019
 
 
TXT Orphan Designation for APX001 Treating Cryptococcosis [256 Words] [ Price : $8.95]
FDA grants Amplyx Pharmaceuticals an orphan drug designation for APX001 and its use for treating cryptococcosis.
02/11/2019
 
 
TXT Latest Federal Register Notices [1379 Words] [ Price : $8.95]
FDA Review posts the Federal Register notice for the week ending 2/8/2019.
02/10/2019
 
 
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