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RSS FeedPosted by Michael Wonder on 30 Jun 2017
Celltrion and Teva announce U.S. FDA acceptance of biologics license application for proposed biosimilar to Rituxan (rituximab)
29 June 2017 - Celltrion and Teva Pharmaceutical Industries today announced that the U.S. FDA has accepted for review the biologics ...
Posted by Michael Wonder on 30 Jun 2017
FDA approves Vectibix (panitumumab) for use in wild type RAS metastatic colorectal cancer
29 June 2017 - Approved companion diagnostic tool strengthens precision medicine approach. ...
Posted by Michael Wonder on 29 Jun 2017
FDA is reviewing generic applications faster, but what about those carryover fees?
28 June 2017 - Now that the FDA plans to fast-track generic drug applications in hopes of spurring competition and ...
Posted by Michael Wonder on 29 Jun 2017
FDA allows marketing of test to aid in the detection of certain leukemias and lymphomas
29 June 2017 - The U.S. FDA today allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first ...
Posted by Michael Wonder on 29 Jun 2017
FDA unveils plan to eliminate orphan designation backlog
29 June 2017 - Today, the U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency’s existing ...
Posted by Michael Wonder on 29 Jun 2017
U.S. FDA grants priority review of Xarelto (rivaroxaban) sNDA for a 10 mg dose to reduce the risk of recurrent venous thromboembolism
28 June 2017 - Approval of 10 mg dose would provide physicians another option to customise patient treatment plans. ...
Posted by Michael Wonder on 28 Jun 2017
FDA commissioner takes on Martin Shkreli-wannabes over huge drug price hikes
28 June 2017 - "We don't play a role in drug pricing, but we do affect drug competition," Dr. Scott Gottlieb ...
Posted by Michael Wonder on 27 Jun 2017
FDA tackles drug competition to improve patient access
27 June 2017 - Agency takes important steps under new Drug Competition Action Plan. ...
Posted by Michael Wonder on 27 Jun 2017
Synlogic receives fast track designation in U.S. for lead candidate, SYNB1020
26 June 2017 - Novel synthetic biotic medicine, SYNB1020, under development for the treatment of hyperammonemia due to urea cycle disorders. ...
Posted by Michael Wonder on 26 Jun 2017
The FDA has never approved a drug like this in its 111 year history
25 June 2017 - This cancer drug produced data so incredible that the FDA approved it immediately for a specific genetic ...
Posted by Michael Wonder on 24 Jun 2017
U.S. FDA approves Bevyxxa (betrixaban) first and only anticoagulant for hospital and extended duration prevention of venous thromboembolism in acutely ill medical patients
23 June 2017 - Portola Pharmaceuticals today announced the U.S. FDA has approved Bevyxxa (betrixaban), the first and only anticoagulant ...
Posted by Michael Wonder on 23 Jun 2017
Cara receives breakthrough therapy designation from FDA for I.V. CR845 for the treatment of chronic kidney disease associated pruritus in hemodialysis patients
23 June 2017 - Phase 3 safety extension trial underway. ...
Posted by Michael Wonder on 23 Jun 2017
Pfizer provides update on proposed epoetin alfa biosimilar
22 June 2017 - Pfizer today announced that it has received a complete response letter from the U.S. FDA regarding the ...
Posted by Michael Wonder on 23 Jun 2017
Haegarda (C1 esterase inhibitor subcutaneous [human]) FDA approval
23 June 2017 - CSL Limited today announced that the U.S. FDA has approved CSL Behring’s Haegarda (C1 esterase inhibitor ...
Posted by Michael Wonder on 23 Jun 2017
FDA approves first subcutaneous C1 esterase Inhibitor to treat rare genetic disease
22 June 2017 - The U.S. FDA today approved Haegarda, the first C1 esterase inhibitor (human) for subcutaneous administration to ...