Blog
RSS FeedPosted by Michael Wonder on 31 Mar 2022
ASC Therapeutics receives key regulatory designations in U.S. and Europe to advance its second generation gene therapy for haemophilia A
29 March 2022 - ASC Therapeutics has received from the U.S. FDA the fast track designation for ASC618, a second-generation gene ...
Posted by Michael Wonder on 30 Mar 2022
FDA officials aim to stop misuse of the term ‘digital biomarker’
29 March 2022 - While a lot of researchers claim they are capturing digital biomarker data, they may in fact be ...
Posted by Michael Wonder on 30 Mar 2022
U.S. FDA accepts for priority review Taiho Oncology's new drug application for futibatinib for cholangiocarcinoma
30 March 2022 - Taiho Oncology and Taiho Pharmaceutical announced today that the U.S. FDA has accepted for priority review the ...
Posted by Michael Wonder on 30 Mar 2022
Akebia Therapeutics receives complete response letter from the FDA for vadadustat for the treatment of anaemia due to chronic kidney disease in adult patients
30 March 2022 - Akebia Therapeutics today announced that the U.S. FDA has issued a complete response letter to Akebia's ...
Posted by Michael Wonder on 30 Mar 2022
ViiV Healthcare announces US FDA approval of Cabenuva (cabotegravir, rilpivirine) for virologically suppressed adolescents living with HIV who are 12 years of age or older and weigh at least 35 kg
29 March 2022 - The expanded indication for the first and only complete long-acting HIV regimen provides an option with as ...
Posted by Michael Wonder on 30 Mar 2022
Enanta Pharmaceuticals receives FDA fast track designation for EDP-235, its oral 3CL protease inhibitor specifically designed for the treatment and prevention of COVID-19
29 March 2022 - Enanta Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for EDP-235, its ...
Posted by Michael Wonder on 30 Mar 2022
ImmunoGen submits biologics license application to the US Food and Drug Administration for mirvetuximab soravtansine in ovarian cancer
29 March 2022 - Submission based on positive results from pivotal Phase 3 SORAYA trial. ...
Posted by Michael Wonder on 29 Mar 2022
FDA authorises second booster dose of two COVID-19 vaccines for older and immunocompromised individuals
29 March 2022 - Today, the U.S. FDA authorised a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 ...
Posted by Michael Wonder on 29 Mar 2022
Gadopiclenol marketing authorisation dossier submissions accepted for review by EMA and FDA
29 March 2022 - Priority review granted by U.S. FDA. ...
Posted by Michael Wonder on 29 Mar 2022
Lipocine announces its partner received FDA approval of Tlando
29 March 2022 - Commercial launch expected in 2Q 2022. ...
Posted by Michael Wonder on 29 Mar 2022
Novo Nordisk receives FDA approval of higher-dose Ozempic 2 mg providing increased glycemic control for adults with type 2 diabetes
28 March 2022 - Ozempic demonstrated 2.1% blood sugar reduction and also weight loss in adults with type 2 diabetes ...
Posted by Michael Wonder on 29 Mar 2022
Santhera and ReveraGen start rolling NDA submission to the FDA for vamorolone for the treatment of Duchenne muscular dystrophy
29 March 2022 - Santhera Pharmaceuticals and ReveraGen BioPharma announce the initiation of a rolling new drug application submission to the ...
Posted by Michael Wonder on 29 Mar 2022
Consequences of US FDA approval decisions in high-income countries
29 March 2022 - Akhade and colleagues highlight the global consequences of approving cancer medicines on the basis of uncertain evidence ...
Posted by Michael Wonder on 28 Mar 2022
U.S. FDA approves Fintempla (fenfluramine) oral solution for treatment of seizures associated with Lennox-Gastaut syndrome
28 March 2022 - Approval based on data where fenfluramine demonstrated efficacy in the most difficult to treat seizure types, including ...
Posted by Michael Wonder on 25 Mar 2022
Bristol Myers Squibb announces new Prescription Drug User Fee Act goal date for Reblozyl (luspatercept-aamt) supplemental biologics license application
25 March 2022 - Bristol Myers Squibb today announced that the U.S. FDA has extended the review of the supplemental ...