Blog
RSS FeedPosted by Michael Wonder on 05 Jan 2021
Genentech’s novel anti-TIGIT tiragolumab granted FDA breakthrough therapy designation in combination with Tecentriq for PD-L1 high non-small cell lung cancer
4 January 2021 - Tiragolumab is the first anti-TIGIT therapy to be granted breakthrough therapy designation and marks the 37th ...
Posted by Michael Wonder on 04 Jan 2021
FDA grants ARX788 fast track designation for HER2 positive metastatic breast cancer
4 January 2021 - Ambrx announced that the U.S. FDA granted ARX788 fast track designation as monotherapy for the treatment of ...
Posted by Michael Wonder on 04 Jan 2021
Provention Bio announces U.S. FDA filing of a biologics license application and priority review for teplizumab for the delay or prevention of clinical type 1 diabetes in at risk Individuals
4 January 2020 - FDA sets PDUFA goal date of 2 July 2021. ...
Posted by Michael Wonder on 04 Jan 2021
US FDA accepts regulatory submission from Pfizer and OPKO for review of somatrogon to treat pediatric patients with growth hormone deficiency
4 January 2020 - If approved, somatrogon will serve as a once-weekly treatment option. ...
Posted by Michael Wonder on 01 Jan 2021
CytRx issues statement regarding U.S. regulatory review of arimoclomol for Niemann-Pick disease type C
31 December 2020 - CytRx today provided an update on the U.S. FDA review of Orphazyme new drug application for arimoclomol ...
Posted by Michael Wonder on 30 Dec 2020
Bristol Myers Squibb statement on Opdivo (nivolumab) small cell lung cancer U.S. indication
29 December 2020 - In 2018, Opdivo (nivolumab) was granted accelerated approval by the U.S. FDA for the treatment of patients ...
Posted by Michael Wonder on 30 Dec 2020
Osmotica Pharmaceuticals receives complete response letter from U.S. Food and Drug Administration for arbaclofen extended release tablets
29 December 2020 - Osmotica Pharmaceuticals today announced that the U.S. FDA has issued a complete response letter regarding the Company's ...
Posted by Michael Wonder on 30 Dec 2020
Eyenovia submits new drug application to FDA for pharmacologic mydriasis with MydCombi targeting 80 million patient encounters in the U.S. annually
29 December 2020 - Eyenovia today announced that it has submitted a new drug application to the U. S. FDA ...
Posted by Michael Wonder on 29 Dec 2020
FDA accepts Alkermes' resubmission of new drug application for ALKS 3831
29 December 2020 - FDA sets PDUFA target action date of 1 June 2021. ...
Posted by Michael Wonder on 29 Dec 2020
Y-mAbs announces sale of priority review voucher
28 December 2020 - Y-mAbs Therapeutics today announced that it has entered into a definitive agreement to sell its priority ...
Posted by Michael Wonder on 29 Dec 2020
Lorbrena (lorlatinib) supplementary new drug application in previously untreated ALK positive lung cancer accepted for priority review by U.S. FDA
28 December 2020 - Supplemental new drug application being reviewed under FDA Real-Time Oncology Review and Project ORBIS pilot programs. ...
Posted by Michael Wonder on 29 Dec 2020
Cara Therapeutics submits new drug application to U.S. FDA for Korsuva injection in haemodialysis patients with moderate to severe pruritus
28 December 2020 - First NDA submission for Company’s lead program, Korsuva injection. ...
Posted by Michael Wonder on 29 Dec 2020
FDA approves first generic of drug used to treat severe hypoglycaemia
28 December 2020 - Today, the U.S. FDA approved the first generic of glucagon for injection USP, 1 mg/vial packaged in ...
Posted by Michael Wonder on 28 Dec 2020
Chi-Med initiates rolling submission of NDA to U.S. FDA for surufatinib for the treatment of advanced neuroendocrine tumours
28 December 2020 - Company plans to complete rolling submission in the first half of 2021. ...
Posted by Michael Wonder on 28 Dec 2020
Imbruvica (ibrutinib) U.S. Prescribing Information updated to include long-term data for Waldenström's macroglobulinemia
23 December 2020 - Updates are based on more than five years of Phase 3 iNNOVATE final analysis data, which demonstrated ...