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RSS FeedPosted by Michael Wonder on 30 Jan 2018
Theravance Biopharma and Mylan announce FDA acceptance of new drug application for revefenacin (TD-4208) in adults with chronic obstructive pulmonary disease
29 January 2018 - FDA assigns PDUFA target action date of 13 November 2018. ...
Posted by Michael Wonder on 30 Jan 2018
Takeda's Zika vaccine gets U.S. FDA's 'fast track' status
30 January 2018 - Japan’s Takeda Pharmaceutical Co Ltd said on Monday the U.S. FDA had granted ‘fast track’ status to ...
Posted by Michael Wonder on 30 Jan 2018
FDA has to explain why Amgen was denied a key marketing incentive
30 January 2018 - Did the FDA treat Amgen differently than Johnson & Johnson when reviewing applications for their drugs? ...
Posted by Michael Wonder on 30 Jan 2018
Aradigm receives complete response letter from the FDA for Linhaliq NDA
29 January 2018 - Aradigm today announces that it received a complete response letter from the US FDA regarding its new ...
Posted by Michael Wonder on 30 Jan 2018
Abeona receives FDA regenerative medicine advanced therapy designation for EB-101 gene therapy in epidermolysis bullosa
29 January 2018 - First gene therapy RMAT designation for epidermolysis bullosa. ...
Posted by Michael Wonder on 29 Jan 2018
FDA approved record number of generic drugs last year
26 January 2018 - The FDA approved 1,027 generic drugs last year, a record number, the Trump administration said Friday. ...
Posted by Michael Wonder on 29 Jan 2018
Roche wins FDA's breakthrough therapy designation for autism drug
29 January 2018 - Swiss drugmaker Roche said on Monday the U.S. FDA granted its breakthrough therapy designation for Balovaptan to ...
Posted by Michael Wonder on 28 Jan 2018
Synthon’s [vic-]trastuzumab duocarmazine (SYD985) granted FDA fast track designation for pre-treated HER2-positive metastatic breast cancer
25 January 2018 - Synthon Biopharmaceuticals today announced that the U.S. FDA has granted fast track designation for its investigational ...
Posted by Michael Wonder on 28 Jan 2018
Transparency and dermatologic device approval by the US Food and Drug Administration
24 January 2018 - What post-approval changes occur to Class III dermatologic devices approved by the US FDA via the ...
Posted by Michael Wonder on 28 Jan 2018
Medical miracles from FDA inefficiency
26 January 2018 - The economist behind the ‘priority review voucher,’ which advances treatments for neglected diseases. ...
Posted by Michael Wonder on 27 Jan 2018
Daliresp receives US FDA approval for 250 mcg starting dose for patients with severe COPD
24 January 2018 - Study shows Daliresp 250 mcg as a starting dose for the first four weeks followed by 500 ...
Posted by Michael Wonder on 26 Jan 2018
FDA approves new treatment for certain digestive tract cancers
26 January 2018 - The U.S. FDA today approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of ...
Posted by Michael Wonder on 26 Jan 2018
Synergy Pharmaceuticals announces FDA approval of Trulance (plecanatide) for the treatment of irritable bowel syndrome with constipation in adults
25 January 2017 - Synergy Pharmaceuticals announced today that the U.S. FDA has approved Trulance (plecanatide) 3 mg tablet for the ...
Posted by Michael Wonder on 23 Jan 2018
FDA accepts investigational new drug application and grants fast track status for SOBI003 for the treatment of MPS IIIA
23 January 2018 - Swedish Orphan Biovitrum announces that the FDA has issued a study may proceed letter for the ...
Posted by Michael Wonder on 23 Jan 2018
The one year anniversary of the Oncology Center of Excellence
19 January 2018 - One year ago, 19 January 2017, FDA officially launched the Oncology Center of Excellence to leverage the ...