Blog
RSS FeedPosted by Michael Wonder on 02 May 2019
Substandard control arms question the utility of some new cancer drugs
2 May 2019 - The rapid pace of new cancer drugs approved by the FDA, 16 in 2018 alone, is ...
Posted by Michael Wonder on 02 May 2019
The antibiotic industry is broken
2 May 2019 - Take inspiration from the entertainment industry. ...
Posted by Michael Wonder on 02 May 2019
FDA advances the science of patient input by seeking specific feedback on patient preferences that may impact regulatory decisions on medical devices
2 May 2019 - The U.S. FDA today opened a docket to receive input from stakeholders on a new priority ...
Posted by Michael Wonder on 02 May 2019
FDA's efforts to advance the development of gene therapy
1 May 2019 - Gene therapy has been on the horizon for several decades and has now become a reality in ...
Posted by Michael Wonder on 02 May 2019
First FDA approved vaccine for the prevention of dengue disease in endemic regions
1 May 2019 - The U.S. FDA announced today the approval of Dengvaxia, the first vaccine approved for the prevention of ...
Posted by Michael Wonder on 01 May 2019
FDA approves Kalydeco (ivacaftor) as first and only CFTR modulator to treat eligible infants with CF as early as six months of age
30 April 2019 - Safety data from Phase 3 ARRIVAL study support treatment with Kalydeco in children ages six to <12 ...
Posted by Michael Wonder on 01 May 2019
Phoenix Tissue Repair receives FDA fast track designation for PTR-01 for the treatment of dystrophic epidermolysis bullosa
30 April 2019 - Phoenix Tissue Repair today announced that the U.S. FDA has granted fast track designation for PTR-01, an ...
Posted by Michael Wonder on 01 May 2019
Janssen submits application to U.S. FDA seeking approval of Erleada (apalutamide) for patients with metastatic castration-sensitive prostate cancer
29 April 2019 - Supplemental new drug application supported by Phase 3 TITAN study; submitted through FDA real-time oncology review program. ...
Posted by Michael Wonder on 01 May 2019
Nabriva Therapeutics receives complete response letter from FDA on NDA for intravenous Contepo (fosfomycin) for injection
30 April 2019 - Issues related to facility inspections and manufacturing deficiencies at one contract manufacturer. ...
Posted by Michael Wonder on 01 May 2019
FDA approves first treatment for all genotypes of hepatitis C in paediatric patients
30 April 2019 - The U.S. FDA today approved Mavyret (glecaprevir and pibrentasvir) tablets to treat all six genotypes of ...
Posted by Michael Wonder on 30 Apr 2019
Finch Therapeutics receives fast track designation for the investigation of full-spectrum microbiota as a treatment for children with autism spectrum disorder
29 April 2019 - Finch Therapeutics announced today that the U.S. FDA has granted fast track designation to its full-spectrum microbiota ...
Posted by Michael Wonder on 30 Apr 2019
Janssen announces submission of new drug application to U.S. FDA for the first monthly, injectable, two drug regimen of rilpivirine and cabotegravir for treatment of HIV
29 April 2019 - If approved, the rilpivirine and cabotegravir regimen would be the first-ever long-acting injectable treatment for adults living ...
Posted by Michael Wonder on 29 Apr 2019
U.S. FDA accepts new drug application and grants priority review for darolutamide
29 April 2019 - Bayer today announced the U.S. FDA has accepted the new drug application and granted priority review to ...
Posted by Michael Wonder on 29 Apr 2019
FDA approves device to help increase access to more lungs for transplant
26 April 2019 - The U.S. FDA today approved a device, called Xvivo Perfusion System with Steen Solution Perfusate, that can ...
Posted by Michael Wonder on 28 Apr 2019
FDA approves Samsung Bioepis' etanercept biosimilar, Eticovo
26 April 2019 - The FDA has approved Samsung Bioepis’ etanercept biosimilar, SB4, as Eticovo (etanercept-ykro). ...