Blog
RSS FeedPosted by Michael Wonder on 09 Feb 2024
Amneal announces complete response resubmission for IPX203 new drug application
8 February 2024 - Amneal Pharmaceuticals today announced that it has provided a complete response resubmission to the US FDA ...
Posted by Michael Wonder on 07 Feb 2024
Bristol Myers Squibb announces acceptance of US and EU regulatory filings for neo-adjuvant Opdivo (nivolumab) and chemotherapy followed by surgery and adjuvant Opdivo in resectable non-small cell lung cancer
7 February 2024 - Applications based on results from CheckMate-77T, the company’s second positive Phase 3 randomised trial with an immunotherapy-based ...
Posted by Michael Wonder on 07 Feb 2024
FDA grants latozinemab breakthrough therapy designation for frontotemporal dementia due to a progranulin gene mutation
7 February 2024 - Latozinemab is the most advanced progranulin-elevating candidate in development for frontotemporal dementia with a progranulin gene mutation ...
Posted by Michael Wonder on 06 Feb 2024
Arvinas and Pfizer’s vepdegestrant (ARV-471) receives FDA fast track designation for the treatment of patients with ER positive/HER2 negative metastatic breast cancer
6 February 2024 - Vepdegestrant is an investigational PROteolysis Targeting Chimera (PROTAC) protein degrader designed to target and degrade the ...
Posted by Michael Wonder on 06 Feb 2024
BridgeBio Pharma announces US FDA acceptance of new drug application for acoramidis for the treatment of patients with transthyretin amyloid cardiomyopathy
5 February 2024 - Accepted with Prescription Drug User Fee Act action date of 29 November 2024; the FDA not currently ...
Posted by Michael Wonder on 04 Feb 2024
Addressing the challenge of common chronic diseases — a view from the FDA
3 February 2024 - Of the 10 most common causes of death in the United States, 7 are chronic diseases: ...
Posted by Michael Wonder on 02 Feb 2024
Linvoseltamab receives EMA filing acceptance for treatment of relapsed/refractory multiple myeloma
2 February 2024 - Regeneron Pharmaceuticals today announced that the EMA has accepted for review the marketing authorisation application for linvoseltamab ...
Posted by Michael Wonder on 02 Feb 2024
Tyra Biosciences receives FDA rare paediatric disease designation for TYRA-300 for the treatment of achondroplasia
1 February 2024 - Tyra Biosciences today announced that the US FDA has granted rare paediatric disease designation to TYRA-300, an ...
Posted by Michael Wonder on 01 Feb 2024
Biosyngen announces FDA fast track designation for BST02 in treatment of liver cancer
1 February 2024 - Biosyngen is proud to announce that its latest groundbreaking product, BST02, has been granted fast track designation ...
Posted by Michael Wonder on 01 Feb 2024
BioNTech and DualityBio receive FDA fast track designation for next generation antibody drug conjugate candidate BNT325/DB-1305
31 January 2024 - Designation is based on preliminary safety and efficacy data from an on-going Phase 1/2 trial in patients ...
Posted by Michael Wonder on 31 Jan 2024
Johnson & Johnson submits supplemental biologics license application to US FDA seeking approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj)-based regimen for the treatment of patients with transplant eligible, newly diagnosed multiple myeloma
30 January 2024 - Data supporting the application showed the addition of Darzalex Faspro to lenalidomide, bortezomib and dexamethasone induction and ...
Posted by Michael Wonder on 31 Jan 2024
Defender Pharmaceuticals receives complete response letter from the US FDA for its intranasal scopolamine new drug application for the prevention of nausea and vomiting induced by motion in adults
30 January 2024 - Defender Pharmaceuticals today announced that the US FDA has issued a complete response letter in response ...
Posted by Michael Wonder on 29 Jan 2024
Celltrion USA completes submission of biologics license application for CT-P47, a biosimilar candidate of Actemra (tocilizumab)
28 January 2024 - The biologics license application for CT-P47 was based on Phase III data comparing CT-P47 to the ...
Posted by Michael Wonder on 29 Jan 2024
Enhertu granted priority review in the US for patients with metastatic HER2 positive solid tumours
29 January 2024 - Application based on results from DESTINY-PanTumor02 trial and supported by additional Enhertu data. ...
Posted by Michael Wonder on 26 Jan 2024
Liquidia provides update on new drug application for Yutrepia (treprostinil) inhalation powder
25 January 2024 - Liquidia announced today that the US FDA provided an update on its review of the new drug ...