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RSS FeedPosted 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 ...
Posted by Michael Wonder on 11 Dec 2020
Pfizer and BioNTech receive FDA Advisory Committee vote supporting potential first emergency use authorisation for vaccine to combat COVID-19 in the U.S
10 December 2020 - FDA expected to make a decision on Emergency Use Authorization in the coming days. ...
Posted by Michael Wonder on 10 Dec 2020
SoniVie receives FDA breakthrough device designation for the TIVUS system for renal artery denervation
9 December 2020 - SoniVie acquires new intellectual property and other assets from Cardiosonic Moving TIVUS into new therapeutic areas beyond ...
Posted by Michael Wonder on 10 Dec 2020
Atox Bio announces FDA acceptance to file the NDA for reltecimod to treat suspected organ dysfunction or failure in patients with necrotising soft tissue infection ("flesh eating disease")
10 December 2020 - Atox Bio today announced that the U.S. FDA has accepted to file the new drug application ...
Posted by Michael Wonder on 10 Dec 2020
Federal watchdog urged to investigate the FDA’s handling of Biogen Alzheimer’s drug
9 December 2020 - A federal watchdog is being asked to investigate the FDA for an “inappropriate collaboration” with Biogen ...
Posted by Michael Wonder on 10 Dec 2020
Pfizer plans to file for full FDA approval of COVID-19 vaccine in April 2021
11 December 2020 - Pfizer said on Thursday it planned to file for full U.S. approval of its experimental coronavirus ...