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RSS FeedPosted 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 ...
Posted by Michael Wonder on 01 Mar 2021
Avadel Pharmaceuticals announces FDA acceptance of new drug application for FT218 in adults with narcolepsy for the treatment of excessive daytime sleepiness and cataplexy
1 March 2021 - FT218 assigned PDUFA target action date of 15 October 2021. ...
Posted by Michael Wonder on 01 Mar 2021
CorMedix receives complete response letter from FDA for DefenCath catheter lock solution
1 March 2021 - CorMedix announced today that the US FDA cannot approve the new drug application for DefenCath (taurolidine/heparin catheter ...
Posted by Michael Wonder on 01 Mar 2021
Athenex receives FDA complete response letter for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer
1 March 2021 - Athenex today announced that the U.S. FDA has issued a complete response letter for the company’s ...
Posted by Michael Wonder on 01 Mar 2021
Rare Disease Day 2021: FDA shows sustained support of rare disease product development during the public health emergency
1 March 2021 - Rare Disease Day is a time to reflect on both the progress that has been made, and ...