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RSS FeedPosted by Michael Wonder on 26 Aug 2021
Moderna completes submission of biologics license application to the US FDA for its COVID-19 vaccine
25 August 2021 - Final blinded analysis of Phase 3 COVE study of the Moderna COVID-19 vaccine shows 93% efficacy; ...
Posted by Michael Wonder on 26 Aug 2021
Ironwood Pharmaceuticals announces FDA approval of revised Linzess (linaclotide) label
26 August 2021 - Ironwood Pharmaceuticals today announced that the U.S. FDA approved a revised label for Linzess (linaclotide) based ...
Posted by Michael Wonder on 26 Aug 2021
Sesen Bio pulls E.U. application for FDA rejected cancer drug
26 August 2021 - Sesen Bio, a small biotech firm whose investigational cancer treatment once seemed poised for approval, said ...
Posted by Michael Wonder on 26 Aug 2021
Servier announces FDA approval of Tibsovo (ivosidenib tablets) in IDH mutated cholangiocarcinoma
25 August 2021 - TIBSOVO is the first and only targeted therapy approved for patients with previously treated IDH1-mutated cholangiocarcinoma. ...
Posted by Michael Wonder on 26 Aug 2021
CellMax Life earns FDA breakthrough device designation for colon cancer & pre-cancerous adenomas screening blood test
25 August 2021 - FirstSight now qualifies for expedited FDA review process as a blood test for detection of advanced neoplasia ...
Posted by Michael Wonder on 26 Aug 2021
COVID-19 vaccine weekly safety report (26 August 2021)
26 August 2021 - To 22 August 2021, approximately 17.1 million vaccine doses have been given in Australia – 10.9 million ...
Posted by Michael Wonder on 26 Aug 2021
Pfizer and BioNTech initiate rolling submission of supplemental biologics license application to U.S. FDA for booster dose of Comirnaty in individuals 16 and older
25 August 2021 - New Phase 3 data show booster (third) dose of Comirnaty induces significant SARS-CoV-2 neutralising antibody titres and ...
Posted by Michael Wonder on 25 Aug 2021
Vertex Pharma gets approval for cystic fibrosis drug for infants in Canada
25 August 2021 - Vertex Pharmaceuticals was given approval to market its drug ivacaftor that treats children as young as ...
Posted by Michael Wonder on 25 Aug 2021
Ascendis Pharma announces U.S. FDA approval of Skytrofa (lonapegsomatropin-tcgd), the first once weekly treatment for paediatric growth hormone deficiency
25 August 2021 - Availability in the U.S. expected shortly supported by a full suite of patient support programs. ...
Posted by Michael Wonder on 25 Aug 2021
FDA accelerates review of Novartis STAMP inhibitor asciminib (ABL001) for patients with chronic myeloid leukaemia
25 August 2021 - Novartis today announced that the US FDA accepted and granted priority review to the company’s new drug ...
Posted by Michael Wonder on 25 Aug 2021
FDA label updates reflect Bayer’s commitment to women’s healthcare
25 August 2021 - FDA approves extension of intrauterine device Mirena (levonorgestrel-releasing intrauterine system) 52 mg for up to seven years ...
Posted by Michael Wonder on 25 Aug 2021
Health Canada grants marketing authorisation for Minjuvi (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma
24 August 2021 - Minjuvi is a new therapeutic option for eligible patients with DLBCL in Canada to address an ...
Posted by Michael Wonder on 25 Aug 2021
Stealth BioTherapeutics submits elamipretide new drug application to FDA for treatment of Barth syndrome
24 August 2021 - Stealth BioTherapeutics today announced the submission of a new drug application to the U.S. FDA for elamipretide, ...
Posted by Michael Wonder on 24 Aug 2021
Immunocore announces that U.S. Food and Drug Administration and European Medicines Agency accept biologics license application and marketing authorisation application for tebentafusp in metastatic uveal melanoma
24 August 2021 - FDA grants priority review to tebentafusp for the treatment of HLA-A*02:01 positive patients with metastatic uveal melanoma; ...
Posted by Michael Wonder on 24 Aug 2021
Humanetics Corporation’s BIO 300 receives fast track designation from FDA
24 August 2021 - Humanetics announced today that BIO 300, a drug under development to increase survival in persons exposed to ...