Blog
RSS FeedPosted by Michael Wonder on 01 Jul 2024
FDA approves biosimilar Pyzchiva (ustekinumab-ttwe), to be commercialised by Sandoz in US
1 July 2024 - FDA granted provisional determination for interchangeability designation for Pyzchiva. ...
Posted by Michael Wonder on 29 Jun 2024
Tubulis receives FDA fast track designation for antibody drug conjugate candidate TUB-040 in platinum-resistant ovarian cancer
27 June 2024 - Designation for TUB-040 in platinum-resistant ovarian cancer is based on preclinical data in a range of models, ...
Posted by Michael Wonder on 29 Jun 2024
Abdera Therapeutics announces FDA fast track designation for ABD-147, a next generation precision radiopharmaceutical therapy, for the treatment of patients with extensive-stage small cell lung cancer
27 June 2024 - Abdera Therapeutics today announced that the US FDA has granted fast track designation to ABD-147 for the ...
Posted by Michael Wonder on 29 Jun 2024
Rocket Pharmaceuticals provides regulatory update on Kresladi (marnetegragene autotemcel)
28 June 2024 - Rocket Pharmaceuticals today announced a regulatory update for Kresladi (marnetegragene autotemcel), a lentiviral vector-based gene therapy ...
Posted by Michael Wonder on 29 Jun 2024
Soleno Therapeutics announces submission of new drug application to the US FDA for diazoxide choline extended-release tablets for the treatment of Prader-Willi syndrome
28 June 2024 - Soleno Therapeutics today announced the submission of a n ew drug application to the US FDA for ...
Posted by Michael Wonder on 29 Jun 2024
Mirum submits new drug application to FDA for chenodiol for the treatment of CTX
28 June 2024 - Mirum Pharmaceuticals today announced the submission of a new drug application for chenodiol for the treatment of ...
Posted by Michael Wonder on 28 Jun 2024
FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory follicular lymphoma
26 June 2024 - Today, the FDA granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab), a bispecific CD20 directed CD3 T-cell ...
Posted by Michael Wonder on 27 Jun 2024
Verona Pharma announces US FDA approval of Ohtuvayre (ensifentrine)
26 June 2024 - First inhaled chronic obstructive pulmonary disease treatment providing bronchodilation and non-steroidal anti-inflammatory effects. ...
Posted by Michael Wonder on 27 Jun 2024
Vir Biotechnology receives FDA fast track designation for tobevibart and elebsiran for the treatment of chronic hepatitis delta infection
26 June 2024 - Fast Track designation follows positive preliminary Phase 2 trial data presented at the European Association for ...
Posted by Michael Wonder on 27 Jun 2024
Carisma Therapeutics granted FDA fast track designation for CT-0525 for the treatment of HER2 overexpressing solid tumours
25 June 2024 - Initial Phase 1 data expected by year end 2024. ...
Posted by Michael Wonder on 27 Jun 2024
Ionis announces olezarsen FCS new drug application accepted for priority review
26 June 2024 - Olezarsen PDUFA date set for 19 December 2024 for treatment of familial chylomicronemia syndrome. ...
Posted by Michael Wonder on 27 Jun 2024
Patritumab deruxtecan BLA submission receives complete response letter from FDA due to inspection findings at third-party manufacturer
27 June 2024 - The letter did not identify any issues with the efficacy or safety data submitted in the ...
Posted by Michael Wonder on 26 Jun 2024
Harmony Biosciences receives US FDA approval for Wakix (pitolisant) in paediatric patients with narcolepsy
24 June 2024 - FDA granted priority review of the sNDA in February 2024. ...
Posted by Michael Wonder on 26 Jun 2024
Otsuka and Lundbeck announce FDA acceptance of sNDA filing for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder
25 June 2024 - The FDA target date (PDUFA date) for completion of the review is 8 February 2025. ...
Posted by Michael Wonder on 25 Jun 2024
AbbVie provides US regulatory update on ABBV-951 (foscarbidopa/foslevodopa)
25 June 2024 - AbbVie continues to work with the FDA to bring ABBV-951 to patients in the US as ...