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RSS FeedPosted by Michael Wonder on 27 Apr 2016
Novartis receives three FDA breakthrough therapy designations for Ilaris to treat rare types of periodic fever syndromes
27 April 2016 - Novartis announced today that the US FDA has granted three breakthrough therapy designations for Ilaris (canakinumab) to ...
Posted by Michael Wonder on 26 Apr 2016
Bristol-Myers Squibb’s Opdivo (nivolumab) receives breakthrough therapy designation from U.S. FDA for previously treated recurrent or metastatic squamous cell carcinoma of the head and neck
25 April 2016 - Bristol-Myers Squibb Company announced today that the FDA has granted breakthrough therapy designation to Opdivo for the ...
Posted by Michael Wonder on 26 Apr 2016
AbbVie receives FDA approval of supplemental new drug application for Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin in genotype 1b chronic hepatitis C patients with compensated cirrhosis
25 April 2016 - AbbVie today announced that the FDA has approved a supplemental new drug application for the use of ...
Posted by Michael Wonder on 26 Apr 2016
Exelixis announces FDA approval of Cabometyx (cabozantinib maleate) tablets for patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy
26 April 2016 - Exelixis today announced that the U.S. FDA has approved Cabometyx (cabozantinib maleate) tablets for the treatment of ...
Posted by Michael Wonder on 26 Apr 2016
Bevespi Aerosphere approved by the US FDA for patients with COPD
22 April 2016 - AstraZeneca announced that the US FDA has approved Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol for ...
Posted by Michael Wonder on 25 Apr 2016
FDA accepts Lundbeck resubmission of new drug application for Carnexiv (carbamazepine)
22 April 2016 - Lundbeck today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the ...
Posted by Michael Wonder on 25 Apr 2016
The FDA vs. Austin Leclaire
25 April 2016 - The agency sits on a new treatment for a deadly muscular disease. ...
Posted 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 ...