Blog
RSS FeedPosted by Michael Wonder on 19 Sep 2020
Agenus initiates rolling BLA submission of balstilimab for recurrent/metastatic cervical cancer
18 September 2020 - Agenus announced the initiation of the rolling submission of its biologics license application to the U.S. FDA ...
Posted by Michael Wonder on 17 Sep 2020
ChemoCentryx announces FDA acceptance of the avacopan new drug application for the treatment of ANCA associated vasculitis
17 September 2020 - FDA sets PDUFA goal date of 7 July 2021. ...
Posted by Michael Wonder on 16 Sep 2020
MediWound announces FDA acceptance of biologics license application for NexoBrid for the treatment of severe thermal burns
16 September 2020 - MediWound today announced that the U.S. FDA has accepted for review its recently submitted biologics license application ...
Posted by Michael Wonder on 15 Sep 2020
Apellis announces submission of pegcetacoplan marketing applications to FDA and EMA for patients with PNH
15 September 2020 - -- Apellis Pharmaceuticals today announced that the company has submitted a new drug application to the ...
Posted by Michael Wonder on 14 Sep 2020
Sol-Gel Technologies announces FDA acceptance for filing of new drug application for Epsolay for the treatment of inflammatory lesions of rosacea
10 September 2020 - Potential to be first FDA-approved single-agent benzoyl peroxide prescription drug product. ...
Posted by Michael Wonder on 08 Sep 2020
Liminal BioSciences announces resubmission of biologics license application to U.S. FDA for Ryplazim (plasminogen)
8 September 2020 - Results from pivotal Phase 2/3 study met co-primary endpoints for improvement in trough plasminogen activity levels and ...
Posted by Michael Wonder on 05 Sep 2020
Ascendis Pharma announces U.S. FDA accepts biologics license application for TransCon hGH for paediatric growth hormone deficiency
4 September 2020 - Prescription Drug User Fee Act target action date of 25 June 2021. ...
Posted by Michael Wonder on 05 Sep 2020
Kite submits supplemental biologics license application to U.S. FDA for Yescarta in relapsed or refractory indolent non-Hodgkin's lymphomas
4 September 2020 - If approved, Yescarta would be the first CAR T therapy for patients with relapsed or refractory ...
Posted by Michael Wonder on 02 Sep 2020
Mirum Pharmaceuticals initiates rolling submission of a new drug application for maralixibat for the treatment of cholestatic pruritus in patients with Alagille syndrome and launches expanded access program
1 September 2020 - Maralixibat would be the first treatment available for use in Alagille syndrome, if approved. ...
Posted by Michael Wonder on 01 Sep 2020
FDA accepts Vertex’s supplemental new drug applications for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), Symdeko (tezacaftor/ivacaftor and ivacaftor) and Kalydeco (ivacaftor) for additional CFTR mutations
1 September 2020 - More than 600 people with certain rare cystic fibrosis mutations could become newly eligible for Trikafta, Symdeko ...
Posted by Michael Wonder on 01 Sep 2020
Athenex announces FDA acceptance for filing of U.S. NDA for oral paclitaxel and encequidar in metastatic breast cancer with priority review
1 September 2020 - FDA grants priority review and sets PDUFA target action date of 28 February 2021. ...
Posted by Michael Wonder on 31 Aug 2020
CorMedix announces FDA acceptance for filing and priority review of new drug application for Defencath
31 August 2020 - FDA sets PDUFA goal date of 28 February 2021. ...
Posted by Michael Wonder on 26 Aug 2020
Sarepta Therapeutics announces FDA acceptance of casimersen (SRP-4045) new drug application for patients with Duchenne muscular dystrophy amenable to skipping exon 45
25 August 2020 - Received FDA's conditional approval of Amondys 45 as brand name for casimersen. ...
Posted by Michael Wonder on 25 Aug 2020
AbbVie aubmits regulatory application to FDA for Rinvoq (upadacitinib) for the treatment of adults with active ankylosing spondylitis
25 August 2020 - In a pivotal Phase 2/3 study, twice as many patients receiving Rinvoq achieved the primary endpoint of ...
Posted by Michael Wonder on 24 Aug 2020
Exelixis announces submission of supplemental new drug application to U.S. FDA for Cabometyx (cabozantinib) in combination with Opdivo (nivolumab) for advanced renal cell carcinoma
24 August 2020 - Submission based on the phase 3 pivotal CheckMate-9ER trial, which met its primary endpoint of significantly improving ...