Blog
RSS FeedPosted by Michael Wonder on 12 Mar 2018
Hikma provides an update on the status of its ANDA for generic Advair Diskus
12 March 2018 - Hikma Pharmaceuticals announces that it is has received a response from the United States FDA in ...
Posted by Michael Wonder on 11 Mar 2018
Key design considerations for adaptive clinical trials: a primer for clinicians
8 March 2018 - This article reviews important considerations for researchers who are designing adaptive clinical trials. ...
Posted by Michael Wonder on 09 Mar 2018
TherapeuticsMD announces FDA acceptance of new drug application and Prescription Drug User Fee Act date for TX-001HR
8 March 2018 - No filing review issues identified. ...
Posted by Michael Wonder on 09 Mar 2018
Veloxis files with FDA for the de novo indication for Envarsus XR
7 March 2018 - Veloxis Pharmaceuticals announced today that it has submitted a supplemental new drug application to the U.S. ...
Posted by Michael Wonder on 08 Mar 2018
23andMe granted first FDA authorisation for direct-to-consumer genetic test on cancer risk
6 March 2018 - Authorisation allows 23andMe to report on BRCA1- and BRCA2-related genetic risk for breast, ovarian and prostate cancer. ...
Posted by Michael Wonder on 08 Mar 2018
Balancing safety and innovation for cell-based regenerative medicine
8 March 2018 - Regenerative medicine is a field that involves replacing, engineering, or regenerating human cells, tissues, or organs to ...
Posted by Michael Wonder on 07 Mar 2018
‘Rigged’ system blocks use of lower cost drugs, FDA Chief says
7 March 2018 - FDA has approved nine biosimilars, only three for sale in U.S. ...
Posted by Michael Wonder on 07 Mar 2018
Sunovion receives FDA approval of supplemental new drug application for use of Latuda (lurasidone hydrochloride) in the treatment of bipolar depression in paediatric patients (10 to 17 years of age)
6 March 2018 - Sunovion Pharmaceuticals today announced that the U.S. FDA approved a supplemental new drug application that expands ...
Posted by Michael Wonder on 06 Mar 2018
FDA approves new HIV treatment for patients who have limited treatment options
6 March 2018 - Today, the U.S. FDA approved Trogarzo (ibalizumab-uiyk), a new type of anti-retroviral medication for adult patients living ...
Posted by Michael Wonder on 06 Mar 2018
Bristol-Myers Squibb’s Opdivo (nivolumab) now the first and only FDA approved PD-1 inhibitor to offer every four week dosing
6 March 2018 - Opdivo also now approved for shorter 30-minute infusions, cutting previous infusion time in half ...
Posted by Michael Wonder on 06 Mar 2018
FDA authorises, with special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes
6 March 2018 - Test only reports 3 out of more than 1,000 known BRCA mutations and negative result doesn’t rule ...
Posted by Michael Wonder on 06 Mar 2018
The Federal Right to Try Act of 2017—a wrong turn for access to investigational drugs and the path forward
6 March 2018 - In 2017, President Trump said that “one thing that’s always disturbed” him is that the US FDA ...
Posted by Michael Wonder on 06 Mar 2018
Jazz Pharmaceuticals announces FDA acceptance of NDA for solriamfetol (JZP-110) for excessive sleepiness associated with narcolepsy or obstructive sleep apnea
2 March 2018 - Jazz Pharmaceuticals today announced that the U.S. FDA has accepted for filing with standard review the company's ...
Posted by Michael Wonder on 05 Mar 2018
Accelerated approval in oncology: FDA touts successes, responds to criticism
5 March 2018 - A majority of oncology treatments granted accelerated approval over the last 25 years have gone on ...
Posted by Michael Wonder on 05 Mar 2018
U.S. FDA accepts new drug application for prucalopride (SHP555) for chronic idiopathic constipation
5 March 2018 - Submission includes real-world evidence from an observational, pharmacoepidemiology cardiovascular safety study. ...