Blog
RSS FeedPosted by Michael Wonder on 24 Feb 2020
Real world evidence - from safety to a potential tool for advancing innovative ways to develop new medical therapies
24 February 2020 - Real world evidence has the potential to enhance the efficiency of drug development and provide new evidence ...
Posted by Michael Wonder on 24 Feb 2020
Novartis announces FDA and EMA filing acceptance of ofatumumab, a novel B-cell therapy for patients with relapsing forms of multiple sclerosis
24 February 2020 - Filings are supported by Phase III ASCLEPIOS I and II studies, where ofatumumab showed highly significant and ...
Posted by Michael Wonder on 23 Feb 2020
FDA approves Lundbeck’s Vyepti (eptinezumab-jjmr) – the first and only intravenous preventive treatment for migraine
22 February 2020 - In two clinical studies (PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine), Vyepti met its ...
Posted by Michael Wonder on 23 Feb 2020
Rare Disease Day 2020: FDA continues important work on treatments for rare diseases
21 February 2020 - As leaders of the FDA, every day we see the unwavering commitment of our agency in working ...
Posted by Michael Wonder on 23 Feb 2020
Esperion announces FDA approval of Nexletol (bempedoic acid) tablet, an oral, once-daily, non-statin LDL-cholesterol lowering medicine
21 February 2020 - Nexletol will be commercially available in the U.S. 30 March 2020. ...
Posted by Michael Wonder on 22 Feb 2020
Trulicity (dulaglutide) is the first and only type 2 diabetes medicine approved to reduce cardiovascular events in adults with and without established cardiovascular disease
21 February 2020 - New indication reflects distinct patient population in the REWIND study, including primarily people with multiple cardiovascular risk ...
Posted by Michael Wonder on 22 Feb 2020
FDA authorises marketing of the first genetic test to aid in the diagnosis of Fragile X syndrome
21 February 2020 - The U.S. Food and Drug Administration today authorised marketing of the first test to detect a genetic ...
Posted by Michael Wonder on 22 Feb 2020
FDA launches new resource to provide easily accessible, more accurate historical drug approval data
21 February 2020 - FDA is launching a new resource to assist external and agency researchers collecting historical information about ...
Posted by Michael Wonder on 21 Feb 2020
BioMarin's biologics license application for valoctocogene roxaparvovec accepted for priority review by FDA with review action date of 21 August 2020
20 February 2020 - No advisory committee meeting currently planned to review the application. ...
Posted by Michael Wonder on 21 Feb 2020
Baudax Bio announces FDA approval of Anjeso for the management of moderate to severe pain
20 February 2020 - U.S. commercial launch planned to commence in late April or early May 2020. ...
Posted by Michael Wonder on 20 Feb 2020
FORMA Therapeutics announces FT-4202 granted fast track designation and rare paediatric disease designation for treatment of sickle cell disease
20 February 2020 - FORMA Therapeutics today announced the U.S. FDA has granted fast track designation and rare paediatric disease ...
Posted by Michael Wonder on 20 Feb 2020
FDA names genes that may interact with specific drugs, offering clarity to genetic testing industry
20 February 2020 - The burgeoning industry built around telling patients how their genes may interact with specific drugs has ...
Posted by Michael Wonder on 20 Feb 2020
FDA announces collaborative review of scientific evidence to support associations between genetic information and specific medications
20 February 2020 - Pharmacogenetic testing is a type of genetic test that in some instances can predict how a person ...
Posted by Michael Wonder on 20 Feb 2020
FDA works to ensure smooth regulatory transition of insulin and other biological products
20 February 2020 - Transition is expected to increase patient access and potentially lower prices on insulin. ...
Posted by Michael Wonder on 20 Feb 2020
Serving public health paramount in a successful 2019 for FDA’s generic drug program
19 February 2020 - Safe, effective, high-quality generic drugs play a vital role in the U.S. health care system. ...