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
GSK’s RSV vaccine, Arexvy, accepted under priority review in US for the prevention of RSV disease in adults aged 50-59 at increased risk
6 February 2024 - Application supported by positive results of a Phase 3 trial showing immune response and acceptable tolerability profile ...
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 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 01 Feb 2024
Adaptimmune announces US FDA acceptance of biologics license application for afami-cel for the treatment of advanced synovial sarcoma with priority review
31 January 2024 - Adaptimmune Therapeutics today announced that the US FDA has accepted for priority review its biologics license application ...
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 30 Jan 2024
Regulatory applications accepted in the US and Japan for Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) in relapsed or refractory follicular lymphoma and relapsed or refractory mantle cell lymphoma
30 January 2024 - US FDA grants both follicular lymphoma and mantle cell lymphoma applications priority review. ...
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 ...
Posted by Michael Wonder on 26 Jan 2024
Theratechnologies receives complete response letter from the FDA for the F8 formulation of tesamorelin sBLA
24 January 2024 - FDA requesting clarifications around chemistry, manufacturing and controls and additional information related to immunogenicity. ...
Posted by Michael Wonder on 24 Jan 2024
UroGen initiates submission of a rolling NDA to the FDA for UGN-102
24 January 2024 - UroGen Pharma today announced the submission of the Chemistry, Manufacturing, and Controls section of the new drug ...
Posted by Michael Wonder on 23 Jan 2024
Theratechnologies receives update from FDA on tesamorelin F8 supplemental biologics license application
23 January 2024 - FDA continues to review the file past the Prescription Drug User Fee Act goal date of ...