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RSS FeedPosted by Michael Wonder on 13 Jan 2022
Mitsubishi Tanabe Pharma America announces FDA acceptance of new drug application for oral edaravone formulation for the treatment of ALS
12 January 2022 - Mitsubishi Tanabe Pharma America today announced the U.S. FDA has accepted the new drug application for an ...
Posted by Michael Wonder on 07 Jan 2022
AbbVie submits applications for upadacitinib (Rinvoq) in non-radiographic axial spondyloarthritis to U.S. FDA and EMA
7 January 2022 - Submissions supported by Phase 3 study in which upadacitinib (Rinvoq) demonstrated significant improvements in signs and symptoms ...
Posted by Michael Wonder on 04 Jan 2022
Spero Therapeutics announces FDA acceptance and priority review of new drug application for tebipenem hydrobromide for the treatment of complicated urinary tract infections including pyelonephritis
3 January 2022 - The FDA has set a Prescription Drug User Fee Act target action date of 27 June 2022. ...
Posted by Michael Wonder on 04 Jan 2022
Novavax submits final data packages to U.S. FDA as prerequisite to Emergency Use Authorisation application request for COVID-19 Vaccine
30 December 2021 - EUA application request to be submitted following one month required by FDA EUA guidance. ...
Posted by Michael Wonder on 31 Dec 2021
FDA accepts Arcutis Biotherapeutics’ new drug application for roflumilast cream for adults and adolescents with plaque psoriasis
22 December 2021 - FDA has set a target action date of 29 July 2022. ...
Posted by Michael Wonder on 31 Dec 2021
Lexicon submits new drug application for sotagliflozin for the treatment of heart failure in adults with type 2 diabetes
30 December 2021 - ) -- Lexicon Pharmaceuticals today announced that it has submitted a new drug application to the U.S. ...
Posted by Michael Wonder on 31 Dec 2021
Amylyx Pharmaceuticals announces FDA acceptance and priority review of new drug application for AMX0035 for the treatment of ALS
29 December 2021 - Amylyx Pharmaceuticals today announced that the U.S. FDA has accepted for review its new drug application for ...
Posted by Michael Wonder on 30 Dec 2021
Janssen submits biologics license application to U.S. FDA seeking approval of teclistamab for the treatment of patients with relapsed or refractory multiple myeloma
29 December 2021 - Janssen announced today the submission of a biologics license application to the U.S. FDA seeking approval ...
Posted by Michael Wonder on 26 Dec 2021
Takeda receives complete response letter from the U.S. FDA for TAK-721
21 December 2021 - Takeda today announced that it has received a complete response letter from the U.S. FDA in ...
Posted by Michael Wonder on 23 Dec 2021
Allarity Therapeutics submits new drug application to the U.S. FDA for dovitinib for third-line treatment of renal cell carcinoma
22 December 2021 - New drug application is supported by Allarity’s previously-filed pre-market approval submission to the FDA for the ...
Posted by Michael Wonder on 22 Dec 2021
Ultomiris regulatory submission accepted under FDA priority review in the US for adults with generalised myasthenia gravis
21 December 2021 - Submission based on positive Phase 3 trial in which Ultomiris significantly improved functional activities as measured ...
Posted by Michael Wonder on 21 Dec 2021
Sandoz submits biologics license application for proposed biosimilar trastuzumab to US FDA
20 December 2021 - Biologics license application is supported by analytical, pre-clinical and clinical data, proposed biosimilar trastuzumab developed by EirGenix. ...
Posted by Michael Wonder on 18 Dec 2021
Pfizer and BioNTech submit supplemental biologics license application for U.S. FDA approval of Comirnaty in adolescents 12 through 15 years of age
16 December 2021 - Pfizer and BioNTech today announced they have submitted a supplemental biologics license application to the U.S. ...
Posted by Michael Wonder on 18 Dec 2021
bluebird bio announces FDA priority review of biologics license application for eli-cel gene therapy for cerebral adrenoleukodystrophy in patients without a matched sibling donor
17 December 2021 - If approved, eli-cel will be the first and only gene therapy for the treatment of cerebral adrenoleukodystrophy, ...
Posted by Michael Wonder on 16 Dec 2021
Verrica Pharmaceuticals announces acceptance by FDA of NDA resubmission for VP-102 for the treatment of molluscum contagiosum
15 December 2021 - Verrica Pharmaceuticals today announced that the U.S. FDA acknowledged that Verrica’s resubmitted new drug application for VP-102 ...