Blog
RSS FeedPosted by Michael Wonder on 03 Mar 2021
KemPharm announces FDA approval of Azstarys (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), a new once daily treatment for ADHD
2 March 2021 - KemPharm today announced that the U.S. FDA has approved the new drug application for Azstarys (formerly referred ...
Posted by Michael Wonder on 03 Mar 2021
FDA grants de novo to ML-based, real-time indicator of patient deterioration
2 March 2021 - Fifth Eye's non-invasive tool is the first to provide continuous monitoring of haemodynamic status using a single ...
Posted by Michael Wonder on 03 Mar 2021
Relivion wearable brain neuromodulation technology cleared by FDA for the treatment of migraine
2 March 2021 - Relivion is the only non-invasive multi-channel neuromodulation technology for the treatment of acute migraine. ...
Posted by Michael Wonder on 02 Mar 2021
Cook Medical receives FDA breakthrough device designation for Zenith fenestrated+ endovascular graft
1 March 2021 - Cook Medical’s Zenith fenestrated+ endovascular graft product has received breakthrough device designation from the US FDA. ...
Posted by Michael Wonder on 02 Mar 2021
Drug industry pushes FDA to solve growing inspection backlog
2 March 2021 - Inspections are a vital tool to ensure the safety of new drugs as well as medicines already ...
Posted by Michael Wonder on 02 Mar 2021
Anuncia receives FDA breakthrough device designation for ReFlow System Mini
2 March 2021 - Anuncia received U.S. FDA breakthrough device designation for its ReFlow System Mini intended for the treatment of ...
Posted by Michael Wonder on 02 Mar 2021
Eyenovia announces FDA acceptance of the MydCombi new drug application
2 March 2021 - Eyenovia today announced that the U.S. FDA has accepted the Company’s new drug application for MydCombi, ...
Posted by Michael Wonder on 02 Mar 2021
Merck provides update on Keytruda (pembrolizumab) indication in metastatic small cell lung cancer in the US
1 March 2021 - Merck today announced the company is voluntarily withdrawing the US indication for Keytruda (pembrolizumab) for the treatment ...
Posted by Michael Wonder on 02 Mar 2021
GC Pharma submits biologics license application to US FDA for immune globulin 'GC5107'
25 February 2021 - Submission for entering the world’s largest US marketplace. ...
Posted by Michael Wonder on 02 Mar 2021
Apollo Endosurgery Receives FDA breakthrough device designation for the Orbera intragastric balloon for treatment of patients with NASH
1 March 2021 - Apollo Endosurgery announced today that it has received a breakthrough device designation from the U.S. FDA for ...
Posted by Michael Wonder on 01 Mar 2021
Vetex Medical receives FDA clearance for Revene thrombectomy catheter
1 March 2021 - Patented dynamic cage technology designed to predictably remove wall-adherent clot in peripheral veins, such as deep ...
Posted by Michael Wonder on 01 Mar 2021
Agios submits supplemental new drug application to FDA for Tibsovo (ivosidenib) for patients with previously treated IDH1 mutant cholangiocarcinoma
1 March 2021 - Agios Pharmaceuticals today announced that it has submitted a Supplemental new drug application to the U.S. FDA ...
Posted by Michael Wonder on 01 Mar 2021
PLx Pharma receives FDA approval of SNDAs for both Vazalore 325 mg and 81 mg
1 March 2021 - Vazalore is the first ever liquid-filled aspirin capsule with an innovative delivery platform indicated as a pain ...
Posted by Michael Wonder on 01 Mar 2021
Vascular Graft Solutions wins FDA approval to Market the VIOLA clampless proximal anastomosis system for CABG
1 March 2021 - Vascular Grafts Solutions announced today receipt of marketing clearance from the FDA for the VIOLA, a new ...
Posted by Michael Wonder on 01 Mar 2021
US FDA accepts Merck’s gefapixant new drug application for review
1 March 2021 - Application for orally administered selective P2X3 receptor antagonist based on findings from two Phase 3 trials in ...