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TXT FDA Approves Amgen sBLA for Blincyto [1133 Words] [ Price : $8.95]
FDA approves an Amgen supplemental BLA for Blincyto (blinatumomab) to include overall survival data from the Phase 3 TOWER study, which also converts Blincyto’s accelerated approval to a full approval.
07/14/2017
 
 
TXT FDA Fast Track for Sangamo Therapies [1159 Words] [ Price : $8.95]
FDA grants Sangamo Therapeutics a fast track designation for SB-318 and SB-913, two clinical stage in vivo genome editing product candidates for treating Mucopolysaccharidosis Type I (MPS I) and MPS II, respectively.
07/14/2017
 
 
TXT FDA Clears Tyber Medical TyFix System [105 Words] [ Price : $8.95]
FDA clears a Tyber Medical 510(k) for TyFix, an all-in-one extremity joint fixation system.
07/14/2017
 
 
TXT FDA Clears Royal Philips Wearable Light Therapy [112 Words] [ Price : $8.95]
FDA clears a Royal Philips 510(k) for the Philips BlueControl wearable light therapy device to treat mild psoriasis.
07/13/2017
 
 
TXT FDA Panel Backs Novartis CAR-T Cell Therapy [388 Words] [ Price : $8.95]
FDA’s Oncologic Drugs Advisory Committee unanimously votes to support approval of a Novartis BLA for CTL019 (tisagenlecleucel-T), a chimeric antigen receptor T-cell for treating pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.
07/13/2017
 
 
TXT FDA Issues May Hinder Anti-abuse Opioids: Tufts [2986 Words] [ Price : $8.95]
A Tufts Center for the Study of Drug Development panel of experts says that a lack of consistent FDA regulatory policy can hinder development of abuse-deterrent opioids.
07/13/2017
 
 
TXT Pfizer Xeljanz sNDA Accepted for Ulcerative Colitis [1155 Words] [ Price : $8.95]
FDA accepts for review a Pfizer supplemental NDA for Xeljanz (tofacitinib citrate) for treating adult patients with moderately to severely active ulcerative colitis.
07/13/2017
 
 
TXT Trump Renews Call to Double Industry User Fees [1269 Words] [ Price : $8.95]
The Trump Administration renews its call for Congress to double user fees paid by industry to help with the government’s budget.
07/13/2017
 
 
TXT FDA Clears TechLab Tri-Combo Parasite Screen [1114 Words] [ Price : $8.95]
FDA clears a TechLab 510(k) for the Tri-Combo Parasite Screen test for detecting Giardia, Cryptosporidium, and Entamoeba histolytica, the three most common intestinal protozoan parasites.
07/13/2017
 
 
TXT FDA Orphan Status for Allena Pharma Drug [1146 Words] [ Price : $8.95]
FDA grants Allena Pharmaceuticals an orphan drug designation for ALLN-177, an oral formulation of oxalate decarboxylase for treating primary hyperoxaluria.
07/13/2017
 
 
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