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RSS FeedPosted by Michael Wonder on 16 Aug 2018
Statement from FDA Commissioner on advancing the science and regulation of live microbiome-based products used to prevent, treat, or cure diseases in humans
16 August 2018 - Over the last several years, there’s been growing scientific and public interest in the role of microorganisms ...
Posted by Michael Wonder on 16 Aug 2018
FDA approves first generic version of EpiPen
16 August 2018 - The U.S. FDA today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for ...
Posted by Michael Wonder on 16 Aug 2018
Ortho Dermatologics resubmits U.S. new drug application for Duobrii (halobetasol propionate and tazarotene) lotion
15 August 2018 - Ortho Dermatologics, a division of Bausch Health, today announced it has resubmitted a new drug application to ...
Posted by Michael Wonder on 16 Aug 2018
FDA approves Kalydeco (ivacaftor) as first and only medicine to treat the underlying cause of CF in children ages 12 to <24 months with certain mutations in the CFTR gene
15 August 2018 - Data from Phase 3 ARRIVAL study support treatment with Kalydeco in children ages 12 to <24 months. ...
Posted by Michael Wonder on 15 Aug 2018
FDA recalls are a reminder that China controls much of world's drug supply
15 August 2018 - "If we were ever in an international incident with China, they would literally have their hands around ...
Posted by Michael Wonder on 15 Aug 2018
FDA advances efficient approaches to designing and conducting cancer clinical trials
14 August 2018 - Over the past decade, advances in understanding of cancer biology have led to the development of targeted ...
Posted by Michael Wonder on 14 Aug 2018
Five predictions for AI and real world data in oncology
14 August 2018 - As progress in oncology care is advancing faster than ever -- especially due to the work ...
Posted 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 ...