Blog
RSS FeedPosted by Michael Wonder on 20 Apr 2016
FDA's breakthrough therapy designation and expedited review programs: Part I
20 April 2016 - A CDER Conversation with Richard Moscicki, M.D., Deputy Director for Science Operations, Center for Drug Evaluation and ...
Posted by Michael Wonder on 20 Apr 2016
FDA’s foray into big data still maturing
20 April 2016 - With access to claims data on about 200 million patients and 5.5 billion patient encounters across the ...
Posted by Michael Wonder on 19 Apr 2016
Shire submits NDA to FDA for new formulation of Vyvanse (lisdexamphetamine dimesylate) CII as chewable tablets
14 April 2016 - Shire recently submitted a NDA to the U.S. FDA for a new, alternate formulation of Vyvanse (lisdexamphetamine ...
Posted by Michael Wonder on 18 Apr 2016
Chiasma provides update regarding FDA’s complete response letter for Mycapssa new drug application
18 April 2016 - Chiasma today provided an update regarding the previously announced complete response letter that was received after the ...
Posted by Michael Wonder on 18 Apr 2016
Merck receives breakthrough therapy designation from U.S. FDA for Keytruda (pembrolizumab) in classical Hodgkin's lymphoma
18 April 2016 - Merck today announced that the U.S. FDA has granted breakthrough therapy designation to Keytruda (pembrolizumab), the company’s ...
Posted by Michael Wonder on 18 Apr 2016
FDA approves Gilotrif (afatinib dimaleate) as new oral treatment option for patients with squamous cell carcinoma of the lung
15 April 2016 - Boehringer Ingelheim today announced that the U.S. FDA has approved a supplemental New Drug Application (sNDA) for ...
Posted by Michael Wonder on 14 Apr 2016
U.S. FDA accepts for priority review Bristol-Myers Squibb’s supplemental biologics license application for Opdivo (nivolumab) for the treatment of classical Hodgkin's lymphoma patients
14 April 2016 - Bristol-Myers Squibb Company announced today that the U.S. FDA accepted a supplemental biologics license application which seeks ...
Posted by Michael Wonder on 13 Apr 2016
Seamless oncology drug development
13 April 2016 - For more than half a century, the clinical development of anti-cancer drugs has followed a predictable and ...
Posted by Michael Wonder on 13 Apr 2016
FDA advisors vote against Clovis' rociletinib
12 April 2016 - It looks likely that Clovis Oncology’s non-small cell lung cancer drug rociletinib will hit a major setback ...
Posted by Michael Wonder on 13 Apr 2016
US approval for IDT brain cancer drug
13 April 2016 - Australian pharmaceutical company IDT’s shares have jumped almost 30 per cent on news of US approval for ...
Posted by Michael Wonder on 13 Apr 2016
FDA accepts supplemental biologics license application for Keytruda (pembrolizumab) in recurrent or metastatic head and neck cancer, and grants priority review
13 April 2016 - Merck today announced that the U.S. FDA has accepted for review the supplemental Biologics License Application (sBLA) ...
Posted by Michael Wonder on 13 Apr 2016
Merck announces FDA acceptance of biologics license application for investigational house dust mite sublingual allergy immunotherapy tablet
12 April 2016 - Merck today announced that the U.S. FDA has accepted for review the Biologics License Application (BLA) for ...
Posted by Michael Wonder on 12 Apr 2016
Physicians’ knowledge about FDA approval standards and perceptions of the “breakthrough therapy” designation
12 April 2016 - This survey study examines how well physicians understand the US FDA’s statutory definition of a “breakthrough” therapy, ...
Posted by Michael Wonder on 12 Apr 2016
Making the most of clinical trial data
12 April 2016 - Data from past clinical trials can be used to draw new conclusions about diseases and treatments long ...
Posted by Michael Wonder on 11 Apr 2016
FDA approves new drug for chronic lymphocytic leukemia in patients with a specific chromosomal abnormality
11 April 2016 - The U.S. FDA today approved Venclexta (venetoclax) for the treatment of patients with chronic lymphocytic leukemia (CLL) ...