Blog
RSS FeedPosted by Michael Wonder on 14 Aug 2018
Motif Bio announces FDA acceptance of new drug application with priority review for iclaprim for treatment of acute bacterial skin and skin structure infections
14 August 2018 - PDUFA action date set for 13 February 2019. ...
Posted by Michael Wonder on 14 Aug 2018
Tech giants pledge to ease patient, provider access to health data
13 August 2018 - Promise seen as opportunity to bring on data-driven revolution in health care. ...
Posted by Michael Wonder on 14 Aug 2018
Cellectar’s CLR 131 receives FDA rare paediatric disease designation for the treatment of Ewing’s sarcoma
13 August 2018 - Cellectar Biosciences announces today that the U.S. FDA has granted rare paediatric disease designation to CLR 131, ...
Posted by Michael Wonder on 14 Aug 2018
FDA grants breakthrough therapy designation for Xolair (omalizumab) for food allergies
12 August 2018 - There are currently no FDA approved treatments that help prevent severe reactions due to food allergies. ...
Posted by Michael Wonder on 13 Aug 2018
FDA accepts new drug application to review midazolam nasal spray, an investigational product for the acute treatment of seizure clusters
13 August 2018 - Midazolam nasal spray has also been granted fast track designation by the US FDA due to the ...
Posted by Michael Wonder on 13 Aug 2018
New class of drugs fulfils promise of RNA-based medicine
13 August 2018 - The approval of a new drug to treat polyneuropathy caused by a rare and frequently fatal ...
Posted by Michael Wonder on 13 Aug 2018
Amicus sets $315,000 price for new Fabry disease treatment
13 August 2018 - Amicus Therapeutics on Monday set an average price of $315,000 per year for its newly approved Fabry ...
Posted by Michael Wonder on 13 Aug 2018
Stemline Therapeutics announces that FDA accepts Elzonris biologics license application and grants priority review
13 August 2018 - Stemline Therapeutics announced today that the U.S. FDA has accepted for filing the company’s biologics license ...
Posted by Michael Wonder on 13 Aug 2018
Gottlieb: FDA will streamline drug safety evaluations
10 August 2018 - The FDA will soon standardise the way it handles data on the safety and effectiveness of ...
Posted by Michael Wonder on 13 Aug 2018
Regeneron provides regulatory update on Eylea (aflibercept) injection sBLA in wet age-related macular degeneration
13 August 2018 - Regeneron Pharmaceuticals today announced that due to ongoing labelling discussions the U.S. FDA has issued a ...
Posted by Michael Wonder on 13 Aug 2018
Promoting patient interests in implementing the Federal Right to Try Act
13 August 2018 - On May 30, 2018, President Trump signed into law the federal Right to Try Act of 2017,1 ...
Posted by Michael Wonder on 13 Aug 2018
Real world evidence and real world data for evaluating drug safety and effectiveness
13 August 2018 - For hundreds of years, the development of new medical treatments relied on “real-world” experience. ...
Posted by Michael Wonder on 12 Aug 2018
FDA approves new vaginal ring for one year of birth control
10 August 2018 - The U.S. FDA today approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), which is a combined ...
Posted by Michael Wonder on 12 Aug 2018
Alnylam prices first gene silencing drug at $450,000 per patient, but offers money-back guarantee
10 August 2018 - This morning, after 16 years and $2.5 billion in investment, the Cambridge, Massachusetts-based company Alnylam finally ...
Posted by Michael Wonder on 11 Aug 2018
IBM bet billions that Watson could improve cancer treatment. It hasn’t worked.
11 August 2018 - Big Blue’s Watson artificial intelligence product sometimes didn’t say more than doctors already knew. ...