Blog
RSS FeedPosted by Michael Wonder on 02 Nov 2018
Sandoz decides not to pursue US biosimilar rituximab; will focus on robust biosimilar portfolio for unmet access and sustainability needs
2 November 2018 - Decision follows FDA request for additional information to complement submission for biosimilar rituximab. ...
Posted by Michael Wonder on 02 Nov 2018
U.S. FDA approves Udenyca (pegfilgrastim-cbqv)
2 November 2018 - Coherus BioSciences today announced that the U.S. FDA has approved Udenyca (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved ...
Posted by Michael Wonder on 02 Nov 2018
Statement from FDA Commissioner on agency’s approval of Dsuvia and the FDA’s future consideration of new opioids
2 November 2018 - The crisis of opioid addiction is an issue of great concern for our nation. Addressing it is ...
Posted by Michael Wonder on 02 Nov 2018
Trevena receives complete response letter for oliceridine from FDA
2 November 2018 - Trevena today announced the Company has received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 02 Nov 2018
FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery
2 November 2018 - Today, the U.S. FDA permitted marketing of two devices that provide real-time location of parathyroid tissue during ...
Posted by Michael Wonder on 02 Nov 2018
Constellation Pharmaceuticals receives FDA fast track designation for CPI-0610 in treatment of myelofibrosis
1 November 2018 - Recently expanded and enhanced MANIFEST Phase 2 trial on-going with proof of concept data expected mid-2019. ...
Posted by Michael Wonder on 02 Nov 2018
Nabriva Therapeutics completes submission of new drug application to U.S. FDA for intravenous Contepo to treat complicated urinary tract infections
1 November 2018 - Nabriva Therapeutics announced it has submitted a new drug application to the U.S. FDA to seek ...
Posted by Michael Wonder on 01 Nov 2018
Director of the FDA’s Center for Devices and Radiological Health and Director of the FDA’s Center for Drug Evaluation and Research on agency’s warning to consumers about genetic tests that claim to predict patients’ responses to specific medications
1 November 2018 - As a public health agency, one of our key roles is to promote and advance safe ...
Posted by Michael Wonder on 31 Oct 2018
Heron announces FDA submission of HTX-011 NDA for post-operative pain management
31 October 2018 - Heron Therapeutics today announced the submission of its new drug application to the U.S. FDA for HTX-011. ...
Posted by Michael Wonder on 31 Oct 2018
FDA authorises first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism
31 October 2018 - Today, the U.S. FDA permitted marketing, with special controls, of the 23andme Personal Genome Service Pharmacogenetic Reports ...
Posted by Michael Wonder on 31 Oct 2018
Industry group wants FDA to stop drug importation study
31 October 2018 - A coalition of insurers and drug manufacturers wants the Trump administration to stop its research into ...
Posted by Michael Wonder on 31 Oct 2018
Sandoz receives US FDA approval for biosimilar Hyrimoz (adalimumab-adaz)
31 October 2018 - Biosimilar Hyrimoz (adalimumab-adaz) approved for all indications of reference medicine not protected by orphan exclusivity. ...
Posted by Michael Wonder on 31 Oct 2018
FDA approves Merck’s Keytruda (pembrolizumab) in combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of patients with metastatic squamous non-small cell lung cancer
30 October 2018 - First anti-PD-1 approved for first-line treatment of squamous non-small cell lung cancer regardless of PD-L1 expression. ...
Posted by Michael Wonder on 31 Oct 2018
FDA grants priority review for Sanofi's dengue vaccine candidate
31 October 2018 - The United States FDA has accepted a biologics license application for Sanofi Pasteur's dengue vaccine. ...
Posted by Michael Wonder on 31 Oct 2018
FDA grants breakthrough therapy designation for UroGen Pharma’s UGN-101 for the treatment of patients with low-grade upper tract urothelial cancer
30 October 2018 - On track to initiate rolling submission of UGN-101 new drug application in Q4 2018. ...