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RSS FeedPosted by Michael Wonder on 27 Aug 2015
FDA approves Repatha to treat certain patients with high cholesterol
27 August 2015 - The U.S. Food and Drug Administration today approved Repatha (evolocumab) injection for some patients who are unable ...
Posted by Michael Wonder on 27 Aug 2015
Nonproprietary naming of biological products
27 August 2015 - The FDA has issued draft guidance on the non-proprietary naming of biological products. ...
Posted by Michael Wonder on 26 Aug 2015
FDA issues draft guidance on common issues in drug development for rare diseases
17 August 2015 - The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled “Rare ...
Posted by Michael Wonder on 26 Aug 2015
FDA grants priority review to Sarepta drug candidate
25 August 2015 - U.S. health regulators granted priority review status for Sarepta Therapeutics Inc.’s treatment of a rare genetic disorder. ...
Posted by Michael Wonder on 25 Aug 2015
Amgen submits new drug application for novel intravenous calcimimetic etelcalcetide (AMG 416)
25 August 2015 - Amgen today announced the submission of a New Drug Application (NDA) with the United States Food and ...
Posted by Michael Wonder on 25 Aug 2015
FDA grants breakthrough therapy designation to Exelixis’ cabozantinib maleate for the treatment of renal cell carcinoma in patients who received one prior therapy
25 August 2015 - Exelixis, Inc. today announced the U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy Designation to ...
Posted by Michael Wonder on 25 Aug 2015
The FDA is basically approving everything. Here's the data to prove it
20 August 2015 - We just got treated to a whole lot of drama this week as to whether Addyi, a ...
Posted by Michael Wonder on 05 Aug 2015
Don’t weaken the F.D.A.’s drug approval process
During the early days of the AIDS epidemic in the 1980s, there were no effective treatments against H.I.V., the virus that ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Boehringer Ingelheim’s Stiolto Respimat as once-daily maintenance treatment for COPD
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved once-daily Stiolto Respimat (tiotropium bromide and olodaterol) Inhalation Spray. ...
Posted by Michael Wonder on 05 Aug 2015
FDA launches openFDA to provide easy access to valuable FDA public data
2 Jun 2014 - Today, the U.S. Food and Drug Administration launched openFDA, a new initiative designed to make it easier ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves new treatment for rare form of hemophilia
The U.S. Food and Drug Administration yesterday approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes ...
Posted by Michael Wonder on 05 Aug 2015
First FDA breakthrough therapy designation for KLH-conjugate immunotherapy signals key step for novel carrier molecule
Stellar Biotechnologies, Inc., the leader in sustainable manufacture of Keyhole Limpet Hemocyanin ("KLH") is encouraged that the U.S. Food and ...
Posted by Michael Wonder on 05 Aug 2015
Eylea (aflibercept) injection receives FDA breakthrough therapy designation for diabetic retinopathy in patients with diabetic macular oedema
Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Eylea (aflibercept) Injection Breakthrough Therapy designation for ...
Posted by Michael Wonder on 05 Aug 2015
Shire announces FDA acceptance for filing with priority review of supplemental new drug application (sNDA) for Vyvanse (lisdexamfetamine dimesylate) capsules for adults with binge eating disorder
Shire plc, the global specialty biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) has accepted for ...
Posted by Michael Wonder on 05 Aug 2015
Pfizer announces FDA acceptance for review of new drug application for a once-daily formulation of Xeljanz (tofacitinib citrate) modified release rablets
Pfizer Inc. announced today that the United States Food and Drug Administration (FDA) accepted for review Pfizer’s new drug application ...