Blog
RSS FeedPosted by Michael Wonder on 30 Mar 2016
Newron receives complete response letter from US FDA for Xadago (safinamide mesylate)
29 March 2016 - Newron Pharmaceuticals and US WorldMeds announced today that a complete response letter from the FDA has been ...
Posted by Michael Wonder on 30 Mar 2016
OPKO Health receives complete response letter from FDA for Rayaldee new drug application
30 March 2016 - OPKO Health announces that the U.S. FDA has issued a complete response letter (CRL) to the company's ...
Posted by Michael Wonder on 30 Mar 2016
FDA approves first treatment for rare disease in patients who receive stem cell transplant from blood or bone marrow
30 March 2016 - The U.S. FDA today approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive ...
Posted by Michael Wonder on 30 Mar 2016
Additional dosage strengths of Otrexup (methotrexate) injection approved by FDA
29 March 2016 - Antares Pharma today announced the approval by the U.S. Food and Drug Administration (FDA) of three ...
Posted by Michael Wonder on 29 Mar 2016
Lundbeck and Takeda receive complete response letter by the FDA for Brintellix (vortioxetine hydrobromide) sNDA
29 March 2016 - Takeda and Lundbeck today announced that the U.S. FDA has issued a complete response letter (CRL) for ...
Posted by Michael Wonder on 25 Mar 2016
FDA takes important step to increase the development of, and access to, abuse-deterrent opioids
24 March 2016 - The U.S. Food and Drug Administration today issued a draft guidance intended to support industry in their ...
Posted by Michael Wonder on 23 Mar 2016
FDA approves Cinqair to treat severe asthma
23 March 2016 - The U.S. Food and Drug Administration today approved Cinqair (reslizumab) for use with other asthma medicines for ...
Posted by Michael Wonder on 22 Mar 2016
FDA approves new psoriasis drug Taltz (ixekizumab)
22 March 2016 - The U.S. Food and Drug Administration today approved Taltz (ixekizumab) to treat adults with moderate-to-severe plaque psoriasis. ...
Posted by Michael Wonder on 22 Mar 2016
US Food and Drug Administration and representation of older adults in clinical trials
21 March 2016 - In the November 10, 2015 issue of Journal of Clinical Oncology, the American Society of Clinical Oncology ...
Posted by Michael Wonder on 21 Mar 2016
FDA approves new treatment for inhalation anthrax
21 March 2016 - The U.S. FDA has approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate ...
Posted by Michael Wonder on 19 Mar 2016
Eagle Pharmaceuticals receives complete response letter from FDA on Kangio (bivalirudin) application
18 March 2016 - Eagle Pharmaceuticals, today announced that it has received a Complete Response Letter from the U.S. FDA for ...
Posted by Michael Wonder on 19 Mar 2016
Allergan confirms generic Abraxane patent challenge
17 March 2016 - Allergan today confirmed that it has filed an abbreviated new drug application with the U.S. FDA seeking ...
Posted by Michael Wonder on 17 Mar 2016
Bayer receives FDA approval for Kovaltry for the treatment of children and adults with haemophilia A
17 March 2016 - The U.S. FDA today approved Bayer’s Kovaltry antihemophilic factor VIII (recombinant) for the treatment of hemophilia A ...
Posted by Michael Wonder on 17 Mar 2016
Novimmune’s NI-0501 granted breakthrough therapy designation by US FDA for treatment of patients with primary haemophagocytic lymphohistiocytosis
16 March 2016 - Novimmune today announced that the US FDA has granted breakthrough therapy designation to NI-0501 for the treatment ...
Posted by Michael Wonder on 16 Mar 2016
Biomarkers and surrogate endpoints
16 March 2016 - This Viewpoint describes the rationale behind an FDA and NIH effort to develop a glossary of common ...