Blog
RSS FeedPosted by Michael Wonder on 16 Dec 2020
US FDA approves world’s first rapid Covid test from Brisbane’s Ellume
16 March 2020 - The US FDA has approved the world’s first rapid at home COVID-19 test, developed by Brisbane-based ...
Posted by Michael Wonder on 15 Dec 2020
FDA committee to meet again Thursday for Moderna's COVID-19 vaccine
14 December 2020 - A Food and Drug Administration advisory committee will meet for the second time in a week to ...
Posted by Michael Wonder on 15 Dec 2020
Rafael Pharmaceuticals receives FDA fast track designation for CPI-613 (devimistat) for the treatment of acute myeloid leukaemia
15 December 2020 - Rafael Pharmaceuticals announced today that the U.S. FDA has granted fast track designation for the Company’s ...
Posted by Michael Wonder on 15 Dec 2020
U.S. FDA accepts new drug application for review, grants priority review for Takeda’s TAK-721 (budesonide oral suspension) for the treatment of eosinophilic oesophagitis
15 December 2020 - If approved, TAK-721 will be the first FDA approved treatment for the chronic inflammatory disease; Takeda plans ...
Posted by Michael Wonder on 15 Dec 2020
FDA awards Genetesis breakthrough device designation for CardioFlux imaging technology
15 December 2020 - Genetesis announced today that its flagship product, CardioFlux, has been granted Breakthrough Device Designation by the U.S. ...
Posted by Michael Wonder on 15 Dec 2020
Almirall announces FDA approval of Klisyri (tirbanibulin), a new innovative topical treatment for actinic keratosis
15 December 2020 - In one of the largest Phase 3 clinical trial programs ever conducted for a topical actinic keratosis ...
Posted by Michael Wonder on 15 Dec 2020
FDA approves Genentech’s Ocrevus (ocrelizumab) shorter 2 hour infusion for relapsing and primary progressive multiple sclerosis
14 December 2020 - Approval based on data from the randomised, double-blind ENSEMBLE PLUS study, showing consistent safety to the conventional ...
Posted by Michael Wonder on 15 Dec 2020
AMAG Pharmaceuticals files submission in response to the FDA’s notice of opportunity for a hearing and proposal to withdraw approval of Makena (hydroxyprogesterone caproate injection)
14 December 2020 - AMAG Pharmaceuticals has submitted its response to the FDA’s Notice of Opportunity for a Hearing regarding the ...
Posted by Michael Wonder on 14 Dec 2020
Avelas receives FDA breakthrough therapy designation for pegloprastide (AVB-620) for use during breast cancer surgery
14 December 2020 - Avelas Biosciences today announced that the company has received breakthrough therapy designation from the U.S. FDA ...
Posted by Michael Wonder on 14 Dec 2020
Public posting of a comprehensive surrogate endpoint table for CDER and CBER regulated products
11 December 2020 - The public posting of a surrogate endpoint table for both reasonably likely and validated surrogate outcomes was ...
Posted by Michael Wonder on 14 Dec 2020
Gannex received U.S. FDA fast track designation for its NASH drug candidate ASC42, an FXR agonist
13 December 2020 - Gannex announced today that it received fast track designation from the U.S. FDA for its non-alcoholic steatohepatitis ...
Posted by Michael Wonder on 13 Dec 2020
Walgreens statement regarding FDA emergency use authorisation of COVID-19 vaccine
11 December 2020 - Walgreens is preparing to immediately bring vaccines to high priority populations, as determined by the Centers ...
Posted by Michael Wonder on 13 Dec 2020
First coronavirus vaccines head to states, starting historic effort
12 December 2020 - Distributing supplies is a daunting logistical challenge, involving sophisticated tracking equipment, military contingencies and tight security. ...
Posted by Michael Wonder on 12 Dec 2020
FDA takes key action in fight against COVID-19 by issuing emergency use authorisation for first COVID-19 vaccine
11 December 2020 - Action follows thorough evaluation of available safety, effectiveness, and manufacturing quality information by FDA career scientists, input ...
Posted by Michael Wonder on 12 Dec 2020
Lexicon Pharmaceuticals receives fast track designation from the FDA for LX9211 for diabetic peripheral neuropathic pain
11 December 2020 - Lexicon Pharmaceuticals announced today that it has received Fast Track designation from the U.S. FDA for ...