Blog
RSS FeedPosted by Michael Wonder on 13 Dec 2017
When can FDA 'Refuse to File' NDAs and BLAs? New draft guidance explains
12 December 2017 - When a new drug application or biologics license application is deemed incomplete by the US FDA, ...
Posted by Michael Wonder on 13 Dec 2017
Omeros Corporation announces FDA approval of Omidria for use in paediatric patients
12 December 2017 - FDA also grants additional market exclusivity. ...
Posted by Michael Wonder on 12 Dec 2017
FDA approves first drug for eosinophilic granulomatosis with polyangiitis, a rare disease formerly known as the Churg-Strauss Syndrome
12 December 2017 - The U.S. FDA today expanded the approved use of Nucala (mepolizumab) to treat adult patients with eosinophilic ...
Posted by Michael Wonder on 11 Dec 2017
FDA approves Admelog, the first short-acting "follow-on" insulin product to treat diabetes
11 December 2017 - The U.S. FDA today approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control ...
Posted by Michael Wonder on 11 Dec 2017
Drug makers continue to owe FDA numerous clinical trials
7 December 2017 - Under various circumstances, the FDA may require a drug maker to run a post-marketing study, but ...
Posted by Michael Wonder on 07 Dec 2017
Sunovion receives FDA approval for Lonhala Magnair inhalation solution to treat COPD
5 December 2017 - Lonhala Magnair is the first nebulised long-acting muscarinic antagonist approved for the treatment of COPD in the ...
Posted by Michael Wonder on 06 Dec 2017
FDA grants Genentech’s Avastin full approval for most aggressive form of brain cancer
5 December 2017 - Genentech announced today that the U.S. FDA has granted full approval for Avastin (bevacizumab) for the ...
Posted by Michael Wonder on 06 Dec 2017
Ozempic (semaglutide) approved in the US
5 December 2017 - Novo Nordisk today announced that the US FDA has approved Ozempic (semaglutide injection). ...
Posted by Michael Wonder on 05 Dec 2017
The FDA’s expedited programs and clinical development times for novel therapeutics, 2012-2016
5 December 2017 - The US FDA has 4 expedited programs to speed the development and review of drugs treating serious ...
Posted by Michael Wonder on 02 Dec 2017
FDA approves Amgen's Repatha (evolocumab) to prevent heart attack and stroke
1 December 2017 - Following FDA priority review, Repatha is the only PCSK9 inhibitor approved to reduce risk of heart attack, ...
Posted by Michael Wonder on 02 Dec 2017
FDA approves first biosimilar for the treatment of certain breast and stomach cancers
1 December 2017 - The U.S. FDA today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment ...
Posted by Michael Wonder on 02 Dec 2017
Lilly's Taltz (ixekizumab) receives U.S. FDA approval for the treatment of active psoriatic arthritis
1 December 2017 - Psoriatic arthritis is the second approved indication for Taltz in the United States. ...
Posted by Michael Wonder on 01 Dec 2017
FDA announces approval, CMS proposes coverage of first breakthrough-designated test to detect extensive number of cancer biomarkers
30 November 2017 - Agencies’ parallel review process makes test for efficient identification of multiple targeted therapy options available to health ...
Posted by Michael Wonder on 01 Dec 2017
FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder
30 November 2017 - Agency encourages safe adoption and more widespread use of FDA-approved treatments to help combat opioid addiction. ...
Posted by Michael Wonder on 30 Nov 2017
FDA approves Ferring’s Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution for colonoscopy prep
29 November 2017 - New ready-to-drink low-volume colonoscopy prep in a pre-mixed liquid solution. ...