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RSS FeedPosted by Michael Wonder on 24 Sep 2021
ATAGI update following weekly COVID-19 meeting (22 September 2021)
24 September 2021 - An update from the Australian Technical Advisory Group on Immunisation following their weekly meeting on 22 September ...
Posted by Michael Wonder on 24 Sep 2021
EU drugs regulator to decide on Pfizer vaccine booster in early October
23 September 2021 - The EMA aims to decide in early October whether to endorse a third dose of the ...
Posted by Michael Wonder on 24 Sep 2021
Ascentage Pharma's MDM2-p53 inhibitor alrizomadlin (APG-115) granted fast track designation by the US FDA for the treatment of relapsed/refractory unresectable or metastatic melanoma
22 September 2021 - Ascentage Pharma today announced that its novel MDM2-p53 inhibitor alrizomadlin (APG-115) has been granted a fast track ...
Posted by Michael Wonder on 23 Sep 2021
A middle ground for accelerated drug approval—lessons from aducanumab
23 September 2021 - The accelerated approval by the US FDA of Biogen’s monoclonal antibody aducanumab (Aduhelm) for treatment of patients ...
Posted by Michael Wonder on 23 Sep 2021
ATAGI statement about the need for additional doses of COVID-19 vaccines
23 September 2021 - A statement from the Australian Technical Advisory Group on Immunisation about the need for COVID-19 vaccine booster ...
Posted by Michael Wonder on 23 Sep 2021
FDA authorises booster dose of Pfizer-BioNTech COVID-19 vaccine for certain populations
22 September 2021 - Today, the U.S. FDA amended the emergency use authorisation for the Pfizer-BioNTech COVID-19 vaccine to allow ...
Posted by Michael Wonder on 23 Sep 2021
COVID-19 vaccine weekly safety report (23 September 2021)
23 September 2021 - To 19 September 2021, approximately 24.8 million vaccine doses have been given in Australia – 15.1 million ...
Posted by Michael Wonder on 22 Sep 2021
Jubilant Radiopharma announces Eckert & Ziegler's GalliaPharm approved for use with NETSpot in Canada
22 September 2021 - Jubilant Radiopharma is the exclusive distributor of GalliaPharm in Canada. ...
Posted by Michael Wonder on 22 Sep 2021
FDA approves ruxolitinib for chronic graft-versus-host disease
22 September 2021 - Today the Food and Drug Administration approved ruxolitinib (Jakafi, Incyte) for chronic graft-versus-host disease after failure ...
Posted by Michael Wonder on 22 Sep 2021
TGA approves Leqvio
22 September 2021 - Inclisiran is a cholesterol lowering double-stranded small interfering ribonucleic acid. ...
Posted by Michael Wonder on 21 Sep 2021
Australia eyes Pfizer’s Covid-19 vaccines for kids aged 5 to 11
21 September 2021 - Australian health officials have confirmed if approved the vaccine would be made widely available to children ...
Posted by Michael Wonder on 21 Sep 2021
bluebird bio submits biologics license application to FDA for betibeglogene autotemcel (beti-cel) gene therapy for patients with β-thalassaemia who require regular red blood cell transfusions
21 September 2021 - Biologics license application submission based on data from Phase 1/2 and Phase 3 Northstar studies, which ...
Posted by Michael Wonder on 21 Sep 2021
Inventiva announces FDA decision that fast track designation granted to lanifibranor in NASH encompasses the treatment of NASH with compensated cirrhosis
21 September 2021 - Inventiva today announced that the U.S. FDA has decided that the fast track designation previously granted to ...
Posted by Michael Wonder on 21 Sep 2021
Incyte announces U.S. FDA approval of Opzelura (ruxolitinib) cream, a topical JAK inhibitor, for the treatment of atopic dermatitis
21 September 2021 - Opzelura is the first and only topical Janus kinase inhibitor approved in the United States. ...
Posted by Michael Wonder on 21 Sep 2021
U.S. Food and Drug Administration reasoning in approval decisions when efficacy evidence is borderline (2013–2018)
21 September 2021 - The U.S. FDA has substantial flexibility in its approval criteria in the context of life-threatening disease and ...