Blog
RSS FeedPosted by Michael Wonder on 15 Mar 2018
FDA accepts for filing supplemental biologics license application for Xeomin (incobotulinumtoxinA) in adult patients with sialorrhoea
14 March 2018 - Merz North America announced today that the U.S. FDA has accepted for filing a supplemental biologics license ...
Posted by Michael Wonder on 14 Mar 2018
House defeats ‘right-to-try’ legislation to allow expanded use of experimental drugs
13 March 2018 - In a major setback for Republicans, the House rejected “right-to-try” legislation Tuesday evening that would have ...
Posted by Michael Wonder on 14 Mar 2018
FDA chief becomes point man on drug prices
14 March 2018 - Scott Gottlieb, head of the FDA, has emerged as a key figure in the Trump administration’s ...
Posted by Michael Wonder on 14 Mar 2018
NovaBiotics’ Lynovex receives fast track designation for cystic fibrosis exacerbations
12 March 2018 - NovaBiotics announces receipt of fast track designation for its cystic fibrosis therapy, Lynovex, from the United States ...
Posted by Michael Wonder on 14 Mar 2018
FDA grants priority review to Merck’s supplemental biologics license application for Keytuda (pembrolizumab) for treatment of advanced cervical cancer
13 March 2018 - First filing acceptance for an anti-PD-1 therapy in cervical cancer. ...
Posted by Michael Wonder on 13 Mar 2018
Lumasiran granted breakthrough therapy designation by the United States FDA
12 March 2018 - Alnylam Pharmaceuticals announced today that Sanofi Genzyme has declined its opt-in for the development and commercialisation ...
Posted by Michael Wonder on 13 Mar 2018
Proteostasis Therapeutics announces FDA grants breakthrough therapy designation for PTI-428 in cystic fibrosis
12 March 2018 - Designation granted for PTI-428 for the treatment of CF patients based on the results from a recent ...
Posted by Michael Wonder on 13 Mar 2018
AmnioFix injectable granted regenerative medicine advanced therapy designation by the FDA for the treatment of osteoarthritis of the knee
9 March 2018 - MiMedx Group today announced that the U.S. FDA has granted MiMedx's micronized amniotic tissue, AmnioFix Injectable, ...
Posted 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. ...