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RSS FeedPosted by Michael Wonder on 02 May 2016
FDA approves Bayer's Gadavist (gadobutrol) injection as first contrast agent for use with magnetic resonance angiography of supra-aortic arteries
29 April 2016 - Bayer announced today that the U.S. FDA has approved Gadavist (gadobutrol) injection for use with magnetic resonance ...
Posted by Michael Wonder on 01 May 2016
Teva announces FDA approval of ProAir RespiClick (salbutamol sulphate) inhalation powder for paediatric asthma patients ages 4 to 11
29 April 2016 - Teva Pharmaceuticals announced today that the U.S. FDA has approved ProAir RespiClick (salbutamol sulphate) inhalation powder for ...
Posted by Michael Wonder on 01 May 2016
FDA approves first drug to treat hallucinations and delusions associated with Parkinson’s disease
29 April 2016 - The U.S. FDA today approved Nuplazid (pimavanserin tartrate), the first drug approved to treat hallucinations and delusions ...
Posted by Michael Wonder on 01 May 2016
FDA approves first generic Crestor
29 April 2016 - The U.S. FDA today approved the first generic version of Crestor (rosuvastatin calcium). ...
Posted 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 27 Apr 2016
FDA issues complete response letter for digital medicine new drug application
26 April 2016 - Otsuka and Proteus Digital Health today announced that the US FDA has issued a complete response letter ...
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
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 ...