Blog
RSS FeedPosted by Michael Wonder on 02 Jan 2017
New drug approvals fall to six-year low in 2016
2 January 2017 - Last year turned out to be a disappointing one for new drug approvals with the U.S. ...
Posted by Michael Wonder on 31 Dec 2016
Costly drug for fatal muscular disease wins FDA approval
30 December 2016 - The FDA has approved the first drug to treat patients with spinal muscular atrophy, a savage ...
Posted by Michael Wonder on 31 Dec 2016
The FDA’s rigged drug committees
30 December 2016 - A case study in how the agency gets the advice it wants to hear. ...
Posted by Michael Wonder on 30 Dec 2016
The head of the FDA defends the importance of drug effectiveness
29 December 2016 - First things first: FDA Robert Califf says that he has not had any contact with the ...
Posted by Michael Wonder on 30 Dec 2016
Coverage denial for therapy unconscionable
29 December 2016 - In regard to your 23 December Editorial “The FDA Empire Strikes Back”. ...
Posted by Michael Wonder on 30 Dec 2016
Cempra receives complete response letter from FDA for solithromycin NDAs
29 December 2016 - Cempra Pharmaceuticals today announced that the company has received a complete response letter from the U.S. ...
Posted by Michael Wonder on 28 Dec 2016
Shire announces FDA approval of Adynovate [anti-haemophilic factor (recombinant), PEGylated] for use in children and surgical settings
27 December 2016 - New FDA-approved indications for Adynovate provides more haemophilia A patients access to proven prophylaxis with a ...
Posted by Michael Wonder on 25 Dec 2016
The FDA's Christmas breakthrough
23 December 2016 - The FDA has always had a tendency to announce big news late on Fridays. ...
Posted by Michael Wonder on 23 Dec 2016
Portola Pharmaceuticals announces FDA accepts new drug application for priority review and EMA validates marketing authorisation application for oral, factor Xa inhibitor anticoagulant betrixaban
23 December 2016 - Portola Pharmaceuticals today announced that the U.S. FDA accepted Portola's new drug application granting priority review ...
Posted by Michael Wonder on 23 Dec 2016
Donald Trump’s pick for Health Secretary traded medical stocks while in house
22 December 2016 - Rep. Tom Price has sponsored and advocated legislation that could affect the companies’ share prices. ...
Posted by Michael Wonder on 23 Dec 2016
FDA approves first drug for spinal muscular atrophy
23 December 2016 - The U.S. FDA today approved Spinraza (nusinersen), the first drug approved to treat children and adults with ...
Posted by Michael Wonder on 21 Dec 2016
FDA accepts supplemental new drug application for Pfizer’s Ibrance (palbociclib) in HR+, HER2- metastatic breast cancer
21 December 2016 - sNDA includes data from Phase 3 PALOMA-2 trial to support conversion from accelerated approval to regular ...
Posted by Michael Wonder on 21 Dec 2016
Janssen submits two applications to FDA seeking approval of Simponi Aria (golimumab) for the treatment of active psoriatic arthritis and active ankylosing spondylitis
20 December 2016 - Janssen Biotech announced today the submission of two supplemental biologics license applications to the U.S. FDA seeking ...
Posted by Michael Wonder on 21 Dec 2016
Tesaro announces priority review designation for niraparib NDA
20 December 2016 - Niraparib new drug application accepted for review by FDA with a PDUFA goal date of 30 ...
Posted by Michael Wonder on 21 Dec 2016
FDA extends review of application for Ocrevus (ocrelizumab)
20 December 2016 - Roche announced today that the U.S. FDA has extended the Prescription Drug User Fee Act date for ...