Blog
RSS FeedPosted by Michael Wonder on 12 Jul 2016
FDA approves new medication for dry eye disease
12 July 2016 - The U.S. FDA approved Xiidra (lifitegrast ophthalmic solution) for the treatment of signs and symptoms of dry ...
Posted by Michael Wonder on 11 Jul 2016
FDA approves first and only single monthly injection for a PCSK9 inhibitor
10 July 2016 - Repatha (evolocumab) Pushtronex system available to U.S. patients in early August. ...
Posted by Michael Wonder on 08 Jul 2016
FDA approves Differin Gel 0.1% for over-the-counter use to treat acne
8 July 2016 - First retinoid approved for over-the-counter use. ...
Posted by Michael Wonder on 08 Jul 2016
Idalopirdine granted fast track designation by U.S. FDA
7 July 2016 - Designation provides the opportunity for more frequent interactions with FDA during clinical development and potential eligibility for ...
Posted by Michael Wonder on 08 Jul 2016
Novartis announces FDA approval of Xolair (omalizumab) for paediatric allergic asthma
7 July 2016 - Extension of indication makes Xolair the first and only approved biologic for pediatric patients six years and ...
Posted by Michael Wonder on 05 Jul 2016
FDA approves treatment for AIDS symptoms
5 July 2016 - Insys says agency OKs Dronabinol oral solution after earlier application was rejected in 2014. ...
Posted by Michael Wonder on 05 Jul 2016
Accelerated drug approval and health inequality
5 July 2016 - This Viewpoint argues that the acceleration of the drug approval process could unequally distribute the costs and ...
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
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
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 ...