Blog
RSS FeedPosted by Michael Wonder on 01 Jul 2017
FDA grants priority review to HIV monoclonal antibody and long-acting investigational anti-retroviral ibalizumab
30 June 2017 - Biologics license application accepted for review with a target action date of 3 January 2018. ...
Posted 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 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 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 22 Jun 2017
Novartis combination targeted therapy Tafinlar and Mekinist receives FDA approval for BRAF V600E mutant metastatic non-small-cell lung cancer
22 June 2017 - Approval provides first targeted treatment in the US specifically for BRAF V600E mutation-positive metastatic non-small-cell lung cancer. ...
Posted by Michael Wonder on 22 Jun 2017
Will Trump’s FDA relax standards for drug approval? We’ll get a clue soon with decision on Portola’s anticoagulant
21 June 2017 - Is the FDA under new Commissioner Scott Gottlieb willing to be flexible with the rules, and ...
Posted by Michael Wonder on 22 Jun 2017
Seattle Genetics submits supplemental biologics license application to FDA for Adcetris (brentuximab vedotin) in cutaneous T cell lymphoma
20 June 2017 - Application based on clinical trial results from the Phase 3 ALCANZA and Phase 2 investigator sponsored ...