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RSS FeedPosted by Michael Wonder on 03 Aug 2022
MediWound announces US FDA acceptance of biologics license application for NexoBrid for the treatment of severe thermal burns
3 August 2022 - Prescription Drug User Fee Act target date of 1 January 2023. ...
Posted by Michael Wonder on 01 Aug 2022
Scynexis announces U.S. FDA acceptance and priority review of the supplemental new drug application for Brexafemme (ibrexafungerp) for prevention of recurrent vaginal yeast infections
1 August 2022 - Submission has been granted priority review and given a target regulatory decision date of 30 November 2022. ...
Posted by Michael Wonder on 01 Aug 2022
Gamida Cell announces FDA acceptance of biologics license application for omidubicel with priority review
1 August 2022 - PDUFA target action date is 30 January 2023. ...
Posted by Michael Wonder on 31 Jul 2022
Gilead Sciences statement on FDA acceptance of new drug application for investigational lenacapavir
27 July 2022 - Gilead Sciences today announced that the U.S. FDA accepted for review the new drug application resubmission for ...
Posted by Michael Wonder on 28 Jul 2022
ImmunityBio announces FDA acceptance of biologics license application for N-803 in BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ
28 July 2022 - This acceptance represents the first regulatory filing for N-803, an IL-15 superagonist, which was granted breakthrough therapy ...
Posted by Michael Wonder on 28 Jul 2022
Acer Therapeutics and Relief Therapeutics announce FDA acceptance for review of NDA resubmission for ACER-001 for treatment of UCDs
28 July 2022 - Prescription Drug User Fee Act target action date set for 15 January 2023. ...
Posted by Michael Wonder on 28 Jul 2022
Cidara Therapeutics submits NDA for rezafungin and announces license agreement with Melinta Therapeutics for commercialisation of rezafungin in the U.S.
27 July 2022 - Submitted new drug application for rezafungin for candidemia and invasive candidiasis to the U.S. FDA on 22 ...
Posted by Michael Wonder on 27 Jul 2022
AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) in Crohn's disease
27 July 2022 - Submissions are supported by three Phase 3 clinical trials demonstrating upadacitinib achieved the co-primary endpoints of clinical ...
Posted by Michael Wonder on 27 Jul 2022
Lexicon announces FDA acceptance of new drug application for sotagliflozin to treat heart failure
27 July 2022 - NDA supported by SOLOIST-WHF and SCORED Global Phase 3 Program evaluating sotagliflozin in almost 12,000 people. ...
Posted by Michael Wonder on 26 Jul 2022
Ionis announces that FDA accepts new drug application and grants priority review of tofersen for a rare, genetic form of ALS
26 July 2022 - 12 month data included in the filing show that earlier initiation of tofersen slowed decline across measures ...
Posted by Michael Wonder on 25 Jul 2022
Treosulphan NDA resubmitted to FDA
25 July 2022 - Pivotal Phase 3 clinical trial of treosulphan met primary endpoint and key secondary endpoints. ...
Posted by Michael Wonder on 25 Jul 2022
Enhertu granted priority review in the U.S. for patients with HER2 low metastatic breast cancer
25 July 2022 - Application being evaluated under FDA Real-Time Oncology Review and Project Orbis. ...
Posted by Michael Wonder on 25 Jul 2022
Applications for proposed first of a kind multiple sclerosis biosimilar natalizumab accepted by US FDA and EMA
25 July 2022 - Submission of proposed biosimilar supported by comprehensive package; aims to expand treatment access for people with multiple ...
Posted by Michael Wonder on 21 Jul 2022
Sandoz supplemental biologics license application accepted by US FDA for biosimilar Hyrimoz (adalimumab-adaz) high concentration formulation
21 July 2022 - Submission supported by comprehensive analytical data package and clinical Phase I pharmacokinetics bridging study. ...
Posted by Michael Wonder on 19 Jul 2022
Apellis announces FDA acceptance and priority review of the new drug application for pegcetacoplan for the treatment of geographic atrophy
19 July 2022 - PDUFA target action date is 26 November 2022. ...