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RSS FeedPosted by Michael Wonder on 05 Jul 2016
FDA approves first absorbable stent for coronary artery disease
5 July 2016 - The U.S. FDA today approved the first fully absorbable stent to treat coronary artery disease. The Absorb ...
Posted by Michael Wonder on 05 Jul 2016
Top officials aim to reshape the FDA to prepare for 'avalanche' of cancer products
30 June 2016 - For 20 years, Richard Pazdur has run the office of the FDA charged with evaluating new cancer ...
Posted by Michael Wonder on 01 Jul 2016
AbbVie's Humira (adalimumab) receives U.S. FDA approval to treat adults with non-infectious intermediate, posterior and panuveitis
30 June 2016 - Approval marks the 10th approved indication for Humira in the United States and follows recent European Commission ...
Posted by Michael Wonder on 29 Jun 2016
FDA clears first test to detect specific genetic markers for certain antibiotic-resistant bacteria directly from clinical specimens
29 June 2016 - The U.S. FDA today cleared for marketing the Xpert Carba-R Assay, an infection control aid that tests ...
Posted by Michael Wonder on 29 Jun 2016
Statement from FDA Commissioner announcing the acting director of the FDA Oncology Center of Excellence
29 June 2016 - The FDA is honored to be an integral part of the Vice President’s National Cancer Moonshot Initiative ...
Posted by Michael Wonder on 29 Jun 2016
FDA approves implantable device that changes the shape of the cornea to correct near vision
29 June 2016 - The U.S. FDA today approved the Raindrop Near Vision Inlay, a device implanted in the cornea (the ...
Posted by Michael Wonder on 29 Jun 2016
Ibrutinib (Imbruvica) granted breakthrough therapy designation by U.S. FDA for the development of a treatment for chronic graft-versus-host disease
29 June 2016 - In current clinical practice, there are no FDA-approved treatments for this life-threatening condition. ...
Posted by Michael Wonder on 28 Jun 2016
FDA approves Epclusa for treatment of chronic Hepatitis C virus infection
28 June 2016 - The U.S. FDA approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with ...
Posted by Michael Wonder on 28 Jun 2016
Roche’s marketing applications for review of Ocrevus (ocrelizumab) in two forms of multiple sclerosis accepted by EMA and FDA
28 June 2016 - Ocrevus is the first investigational medicine seeking marketing authorisation for both relapsing and primary progressive multiple sclerosis. ...
Posted by Michael Wonder on 27 Jun 2016
Bristol-Myers Squibb’s Opdivo (nivolumab) receives breakthrough therapy designation from U.S. FDA for advanced form of bladder cancer
27 June 2016 - This milestone marks the sixth breakthrough therapy designation for Opdivo. ...
Posted by Michael Wonder on 24 Jun 2016
Allergan announces FDA approval of supplemental new drug application for Avycaz (ceftazidime and avibactam)
23 June 2016 - Label now includes Phase 3 clinical data evaluating the safety and efficacy of Avycaz (in combination with ...
Posted by Michael Wonder on 21 Jun 2016
FDA approves new drug application for Rayaldee to treat secondary hyperparathyroidism associated with vitamin D insufficiency in stage 3-4 chronic kidney disease
21 June 2016 - U.S. launch planned for 2H 2016. ...
Posted by Michael Wonder on 21 Jun 2016
Mitsubishi Tanabe Pharma submits new drug application for edaravone to treat ALS in the United States
20 June 2016 - Mitsubishi Tanabe Pharma Corporation today announced that a new drug application has been submitted to the ...
Posted by Michael Wonder on 20 Jun 2016
Ariad initiates submission of new drug application for brigatinib to the U.S. FDA ahead of plan
17 June 2016 - Ariad Pharmaceuticals today announced the initiation of a new drug application submission for its investigational anaplastic lymphoma ...
Posted by Michael Wonder on 16 Jun 2016
Charleston Laboratories and Daiichi Sankyo announce FDA acceptance of new drug application for CL-108
13 June 2016 – Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. today announced that the U.S. FDA has accepted for ...