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RSS FeedPosted by Michael Wonder on 26 Sep 2016
Sanofi and Regeneron announce dupilumab biologics license application accepted for priority review by U.S. FDA
26 September 2016 - Sanofi and Regeneron Pharmaceuticals today announced that the U.S. FDA has accepted for priority review the biologics ...
Posted by Michael Wonder on 26 Sep 2016
AbbVie announces submission of a supplemental new drug application for Ibrutinib (imbruvica) for treatment of marginal zone lymphoma
26 September 2016 - If approved by the U.S. FDA, ibrutinib will be the first therapy specifically approved for patients with ...
Posted by Michael Wonder on 26 Sep 2016
US FDA approves labeling update of Rexulti (brexpiprazole) for maintenance treatment of schizophrenia
24 September 2016 - Labeling update includes clinical data on use of Rexulti in adult patients with schizophrenia in the maintenance ...
Posted by Michael Wonder on 26 Sep 2016
Janssen submits application seeking approval of sirukumab in United States for rheumatoid arthritis
23 September 2016 - Janssen announced today the submission of a biologics license application to the U.S. FDA seeking approval ...
Posted by Michael Wonder on 24 Sep 2016
FDA approves Amgen's Amjevita (adalimumab-atto) for treatment of seven inflammatory diseases
23 September 2016 - First biosimilar adalimumab approved by FDA. ...
Posted by Michael Wonder on 23 Sep 2016
FDA approves expanded indications for Ilaris for three rare diseases
23 September 2016 - The U.S. FDA today approved three new indications for Ilaris (canakinumab). ...
Posted by Michael Wonder on 22 Sep 2016
The FDA did the right thing by approving a novel drug for a disabling disease
22 September 2016 - The FDA’s leadership did the right thing, according to Elaine Schattner in Forbes magazine. ...
Posted by Michael Wonder on 22 Sep 2016
FDA commissioner calls for Sarepta clinical trial to be retracted
22 September 2016 - In an unusual development, the US FDA Commissioner Dr. Robert Califf has indicated that a clinical trial ...
Posted by Michael Wonder on 21 Sep 2016
FDA and access to medications
14 September 2016 - The FDA doesn’t regulate drug prices – prices are set by the drug makers or distributors. ...
Posted by Michael Wonder on 21 Sep 2016
Evaluating the FDA’s approach to cancer clinical trials
16 September 2016 - Since the announcement of the FDA Oncology Center of Excellence in June 2016 as part of the ...
Posted by Michael Wonder on 21 Sep 2016
U.S. FDA approves Invokamet XR (canagliflozin with metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes
21 September 2016 - Newest Invokana (canagliflozin) plus metformin treatment provides unique formulation option for first-line therapy. ...
Posted by Michael Wonder on 21 Sep 2016
DBV Technologies receives FDA fast track designation for Viaskin Milk for the treatment of cow’s milk protein allergy
21 September 2016 - DBV first to announce fast track designation for IgE-mediated CMPA; Viaskin Milk is currently being investigated ...
Posted by Michael Wonder on 20 Sep 2016
The boys who beat the FDA
19 September 2016 - The agency approves a new medicine after an ugly bureaucratic brawl. ...
Posted by Michael Wonder on 20 Sep 2016
Sarepta to charge $300K for Duchenne drug. ‘We tried to be reasonable,’ CEO says
19 September 2016 - The newly approved Sarepta Therapeutics drug for Duchenne muscular dystrophy will cost about $300,000 a year for ...
Posted by Michael Wonder on 20 Sep 2016
Did the FDA set ‘a dangerous precedent’ with its latest drug approval?
19 September 2016 - The experimental drug that the FDA approved Monday will only be used by a few thousand patients. ...