Blog
RSS FeedPosted by Michael Wonder on 28 Aug 2019
FDA urges inclusion of men in breast cancer clinical trials
28 August 2019 - Men with breast cancer make up less than one percent of all breast cancer cases, but ...
Posted by Michael Wonder on 28 Aug 2019
Placebos and blinding in randomised controlled cancer clinical trials for drug and biological products: guidance for industry
28 August 2019 - This guidance provides recommendations to industry about the use of placebos and blinding in randomised controlled clinical ...
Posted by Michael Wonder on 28 Aug 2019
Academics and researchers raise concerns with FDA’s plan for ‘integrated reviews’
28 August 2019 - More than 50 academics and researchers from Harvard, Yale, Johns Hopkins and other universities around the ...
Posted by Michael Wonder on 28 Aug 2019
FDA warns testing companies: don’t tell patients how their DNA influences response to specific drugs
28 August 2019 - Amid a boom in genetic testing that aims to predict a person’s response to medication, the ...
Posted by Michael Wonder on 27 Aug 2019
DiscGenics receives FDA fast track designation for disc degeneration cell therapy
26 August 2019 - DiscGenics today announced that the U.S. FDA has granted Fast Track designation for its investigational cell ...
Posted by Michael Wonder on 27 Aug 2019
Congress should be promoting, not discouraging, the development of biosimilars
27 August 2019 - Drug prices continue to dominate the headlines, yet many of the policy ideas being considered in ...
Posted by Michael Wonder on 27 Aug 2019
We need a more rational biosimilars policy
27 August 2019 - Throwing in the towel on a whole new category of medicines, just shy of a decade in, ...
Posted by Michael Wonder on 27 Aug 2019
FDA approves new add-on drug to treat off episodes in adults with Parkinson's disease
27 August 2019 - The U.S. FDA today approved Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients ...
Posted by Michael Wonder on 27 Aug 2019
Delivering promising new medicines without sacrificing safety and efficacy
27 August 2019 - All drugs approved under the agency’s expedited programs are held to the same approval standards as other ...
Posted by Michael Wonder on 27 Aug 2019
Akorn receives FDA approval for azelastine hydrochloride 0.15% nasal spray
26 August 2019 - Akorn today announced that it received a new Abbreviated new drug application approval from the U.S. FDA ...
Posted by Michael Wonder on 27 Aug 2019
Viela Bio announces U.S. FDA accepts for review inebilizumab biologics license application for neuromyelitis optica spectrum disorder
27 August 2019 - U.S. FDA accepts for review Viela Bio's first BLA filing. ...
Posted by Michael Wonder on 27 Aug 2019
An FDA report reveals the agency believed Novartis data problems were resolved months ago
27 August 2019 - Shortly before serious data problems surfaced in mid-March at a troubled Novartis unit, a Food and ...
Posted by Michael Wonder on 27 Aug 2019
FDA grants fast track designation for Farxiga in chronic kidney disease
27 August 2019 - AstraZeneca today announced that the US FDA has granted fast track designation for the development of ...
Posted by Michael Wonder on 26 Aug 2019
FDA approves US WorldMeds' Myobloc (rimabotulinumtoxinB) injection for chronic sialorrhea
26 August 2019 - Myobloc is the only approved botulinum toxin for chronic sialorrhoea that provides significant results in as early ...
Posted by Michael Wonder on 26 Aug 2019
Developing real-world data and evidence to support regulatory decision-making
26 August 2019 - On 3 October, the FDA and the Duke-Margolis Center for Health Policy will hold a conference, ...