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RSS FeedPosted by Michael Wonder on 07 May 2025
ImmunityBio requests an urgent meeting with FDA to address the change in the Agency’s unambiguous guidance on Jan 2025 to submit a sBLA for NMIBC BCG unresponsive papillary disease, following an inconsistent refusal to file letter on 2 May 2025
5 May 2025 - ImmunityBio today announced that the Company received a refusal to file letter from the US FDA for ...
Posted by Michael Wonder on 06 May 2025
FDA accepts resubmission of BLA for narsoplimab for haematopoietic stem cell transplant-associated thrombotic microangiopathy and assigns late September PDUFA date
6 May 2025 - Omeros Corporation today announced that the US FDA has accepted for review the resubmission of the biologics ...
Posted by Michael Wonder on 03 May 2025
FDA accepts filing application for oral semaglutide 25 mg, which if approved, would be the first oral GLP-1 treatment for obesity
2 May 2025 - The FDA filing is based on the results of the Phase 3 OASIS 4 trial that evaluated ...
Posted by Michael Wonder on 02 May 2025
Cytokinetics announces new PDUFA date for aficamten in obstructive hypertrophic cardiomyopathy
1 May 2025 - Cytokinetics today announced that the US FDA has extended the PDUFA action date for the New Drug ...
Posted by Michael Wonder on 29 Apr 2025
Eton Pharmaceuticals announces submission of NDA for ET-600 (desmopressin oral solution)
28 April 2025 - Expected 10 month review; commercial preparations underway for a potential Q1 2026 launch. ...
Posted by Michael Wonder on 27 Apr 2025
AbbVie submits biologics license application to US FDA for trenibotulinumtoxinE (TrenibotE) for the treatment of glabellar lines
24 April 2025 - Submission is supported by data from over 2,100 patients treated with TrenibotE throughout the clinical program. ...
Posted by Michael Wonder on 18 Apr 2025
Regeneron provides update on Eylea HD (aflibercept) injection 8 mg supplemental biologics license application
18 April 2025 - Regeneron Pharmaceuticalstoday announced that the US FDA has issued a complete response letter regarding the supplemental biologics ...
Posted by Michael Wonder on 17 Apr 2025
Eylea HD (aflibercept) injection 8 mg sBLA accepted for FDA priority review for both the treatment of macular oedema following retinal vein occlusion and for monthly dosing in approved indications
17 April 2025 - If approved, Eylea HD would be the first and only treatment for RVO indicated for up to ...
Posted by Michael Wonder on 16 Apr 2025
FDA grants fast track status to Prescient’s PTX-100, advancing commercialisation pathway
16 April 2025 - Prescient Therapeutics has received fast track designation from the US FDA for its lead candidate PTX-100, ...
Posted by Michael Wonder on 11 Apr 2025
FDA approves nivolumab with ipilimumab for unresectable or metastatic hepatocellular carcinoma
11 April 2025 - Today, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, ...
Posted by Michael Wonder on 09 Apr 2025
Outlook Therapeutics announces acceptance of biologics license application by US FDA for ONS-5010 as a treatment for wet AMD
8 April 2025 - PDUFA goal date of 27 August 2025. ...
Posted by Michael Wonder on 09 Apr 2025
Xspray Pharma re-submits its FDA application
8 April 2024 - Xspray Pharma has re-submitted its application for market approval for Dasynoc, the company's lead product candidate, an ...
Posted by Michael Wonder on 09 Apr 2025
Tenpoint Therapeutics submits new drug application to US FDA for Brimichol PF for the treatment of presbyopia
8 April 2025 - NDA submission includes efficacy and safety data for the first fixed-dose combination therapy from the world’s ...
Posted by Michael Wonder on 08 Apr 2025
Kura Oncology and Kyowa Kirin announce submission of new drug application for ziftomenib to FDA
8 April 2025 - Submission seeks approval for the treatment of adult patients with relapsed or refractory AML with a ...
Posted by Michael Wonder on 08 Apr 2025
Teva announces FDA filing acceptance for Ajovy (fremanezumab) in paediatric episodic migraine prevention
7 April 2025 - If approved for an expanded paediatric indication, Ajovy would be the first calcitonin gene-related peptide antagonist for ...