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RSS FeedPosted 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 ...
Posted by Michael Wonder on 21 Sep 2021
Lilly announces procurement agreement with European Commission to supply bamlanivimab and etesevimab together for the treatment of confirmed COVID-19
21 September 2021 - Joint Procurement Agreement enables European countries to purchase bamlanivimab and etesevimab directly from Lilly, in varying ...
Posted by Michael Wonder on 21 Sep 2021
FDA authorises software that can help identify prostate cancer
21 September 2021 - Today, the U.S. FDA authorised marketing of software to assist medical professionals who examine body tissues (pathologists) ...
Posted by Michael Wonder on 21 Sep 2021
FDA approves Lexette for adolescent plaque psoriasis
21 September 2021 - Mayne Pharma is pleased to announce that the U.S. FDA has approved Lexette (halobetasol propionate) foam, ...
Posted by Michael Wonder on 21 Sep 2021
Rhythm Pharmaceuticals completes submission of supplemental new drug application to U.S. Food and Drug Administration for Imcivree (setmelanotide) for the treatment of obesity and control of hunger in Bardet-Biedl and Alström syndromes
20 September 2021 - Rhythm Pharmaceuticals today announced that it has completed its supplemental new drug application to the U.S. FDA ...
Posted by Michael Wonder on 20 Sep 2021
Abbott receives FDA approval for minimally invasive Portico with Flexnav TAVR system to treat patients with aortic valve disease
20 September 2021 - Transcatheter aortic valve replacement procedure treats people with symptomatic, severe aortic stenosis who are at high or ...
Posted by Michael Wonder on 20 Sep 2021
Seagen and Genmab announce FDA accelerated approval for Tivdak (tisotumab vedotin-tftv) in previously treated recurrent or metastatic cervical cancer
20 September 2021 - Seagen and Genmab today announced that the U.S. FDA has granted accelerated approval to Tivdak (tisotumab ...
Posted by Michael Wonder on 20 Sep 2021
Alvotech provides update on FDA action regarding AVT02, proposed high concentration biosimilar to Humira (adalimumab)
20 September 2021 - Alvotech today announced that the FDA is deferring action on the application for AVT02, the company’s proposed ...