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RSS FeedPosted by Michael Wonder on 02 Feb 2018
FDA approves Avycaz (ceftazidime and avibactam) for the treatment of patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia
1 February 2018 - First gram-negative antibiotic approved in the U.S. to treat HABP/VABP in over 15 years. ...
Posted by Michael Wonder on 01 Feb 2018
A revolution in health care is coming
1 February 2018 - Welcome to Doctor you. ...
Posted by Michael Wonder on 31 Jan 2018
Trump urges U.S. Congress to back 'right to try' for terminally ill
31 January 2018 - President Donald Trump said in his State of the Union address to the U.S. Congress on Tuesday ...
Posted by Michael Wonder on 31 Jan 2018
Alkermes submits new drug application to U.S. FDA for ALKS 5461 for the adjunctive treatment of major depressive disorder
31 January 2018 - New medicine for treating major depressive disorder supported by comprehensive efficacy and safety data package from ...
Posted by Michael Wonder on 31 Jan 2018
New drugs, but slow access — here's how to speed breakthroughs to patients
30 January 2018 - The U.S. FDA approved 46 novel drugs in 2017, a 21-year high. However, it could take ...
Posted 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. ...