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RSS FeedPosted by Michael Wonder on 29 Apr 2016
Therabron Therapeutics receives FDA fast track designation for rhCC10 for the prevention of chronic lung disease related to premature birth
28 April 2016 - Therabron Therapeutics announced today that it has received Fast Track Designation from the U.S. FDA for ...
Posted by Michael Wonder on 29 Apr 2016
FDA grants Advaxis fast track designation for ADXS-HER2 for patients with newly-diagnosed, non-metastatic osteosarcoma
28 April 2016 - Advaxis today announced that the FDA has granted Fast Track Designation for the company’s immunotherapy product candidate ...
Posted by Michael Wonder on 27 Apr 2016
Lilly's Taltz cleared in the EU for plaque psoriasis
27 April 2016 - The European Commission has approved Eli Lilly’s biologic Taltz as a new treatment for moderate to severe ...
Posted 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
Aralez Pharmaceuticals receives Health Canada approval for Blexten
25 April 2016 - Aralez Pharmaceuticals today announced the Health Canada approval of Blexten (bilastine 20 mg tablets) for the treatment ...
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 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 22 Apr 2016
Integrating patients’ views in clinical studies of anti-cancer medicines
22 April 2016 - The EMA has published new guidance on the use of patient-reported outcome (PRO) measures in oncology ...
Posted by Michael Wonder on 21 Apr 2016
Applications for new human medicines under evaluation by the CHMP - April 2016 update
20 April 2016 - The EMA has published information on applications for centralised marketing authorisation for human medicines that the agency ...
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 ...