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RSS FeedPosted by Michael Wonder on 04 Mar 2022
Nymox announces submission of new drug application to the FDA for fexapotide triflutate
3 March 2022 - Nymox Pharmaceutical Corporation is pleased to announce today that it has submitted the Company’s new drug application ...
Posted by Michael Wonder on 03 Mar 2022
TG Therapeutics announces extension of U.S. FDA BLA/sNDA PDUFA date for ublituximab plus Ukoniq to treat patients with CLL and SLL
3 March 2022 - FDA sets updated PDUFA goal date of June 25, 2022. ...
Posted by Michael Wonder on 03 Mar 2022
FDA accepts Alvotech’s BLA supporting interchangeability for ATV02, a high concentration, citrate-free biosimilar candidate for Humira
28 February 2022 - Alvotech is the only known company to have both developed a high-concentration biosimilar to Humira and ...
Posted by Michael Wonder on 02 Mar 2022
Cormedix announces resubmission of new drug application for Defencath
28 February 2022 - CorMedix today announced that it has resubmitted the new drug application for DefenCath to address the ...
Posted by Michael Wonder on 01 Mar 2022
U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for Opdivo (nivolumab) plus chemotherapy as neo-adjuvant treatment for resectable non-small cell lung cancer
28 February 2022 - Application based on CheckMate-816, the first Phase 3 trial with an immunotherapy-based combination to demonstrate improved event-free ...
Posted by Michael Wonder on 01 Mar 2022
Lexicon voluntarily withdraws sotagliflozin new drug application and plans prompt resubmission targeted early Q2 2022
28 February 2022 - Resubmission to Correct Recently-Identified Technical Issue. ...
Posted by Michael Wonder on 01 Mar 2022
AbbVie provides update regarding Skyrizi (risankizumab-rzaa) for the treatment of moderate to severe Crohn's disease in the U.S.
28 February 2022 - AbbVie today announced that the U.S. FDA has extended its review period for Skyrizi (risankizumab-rzaa) for ...
Posted by Michael Wonder on 28 Feb 2022
AbbVie seeks new indication for Imbruvica (ibrutinib) in paediatric patients with chronic graft versus host disease
28 February 2022 - The sNDA and NDA submissions were primarily based on results of three years of data from ...
Posted by Michael Wonder on 27 Feb 2022
Update on Tyvaso DPI new drug application
24 February 2022 - MannKind Corporation was informed that the U.S. FDA issued an information request to United Therapeutics Corporation ...
Posted by Michael Wonder on 26 Feb 2022
FDA accepts for review Pfizer’s supplemental application for Abrilada (adalimumab-afzb) interchangeability
25 February 2022 - Pfizer today announced that the U.S. FDA has accepted for review the prior approval supplement to the ...
Posted by Michael Wonder on 24 Feb 2022
United Therapeutics Corporation reports fourth quarter and full year 2021 financial results
24 February 2022 - Major amendment to Tyvaso DPI new drug application pushes FDA decision date to May 2022. ...
Posted by Michael Wonder on 24 Feb 2022
Rhythm Pharmaceuticals announces FDA extension of review period for Imcivree (setmelanotide) for patients with Bardet-Biedl syndrome and Alström syndrome
24 February 2022 - FDA sets updated PDUFA goal date of 16 June 2022. ...
Posted by Michael Wonder on 23 Feb 2022
Provention Bio announces biologics license application resubmission for teplizumab to address complete response letter
22 February 2022 - Provention Bio today announced it has resubmitted the biologics license application for teplizumab for the delay ...
Posted by Michael Wonder on 22 Feb 2022
BeiGene announces U.S. FDA acceptance of supplemental new drug application for Brukinsa (zanubrutinib) in chronic lymphocytic leukaemia
22 February 2022 - The Prescription Drug User Fee Act target action date is 22 October 2022. ...
Posted by Michael Wonder on 22 Feb 2022
AbbVie submits supplemental new drug application to U.S. FDA for cariprazine (Vraylar) for the adjunctive treatment of major depressive disorder
22 February 2022 - Submission is based on clinical trial results that include findings showing clinically and statistically significant improvement in ...