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RSS FeedPosted by Michael Wonder on 22 May 2025
PharmaMar has submitted EU marketing authorization application for lurbinectedin in combination with atezolizumab in first-line maintenance therapy for extensive-stage small cell lung cancer
21 May 2025 - PharmaMar has submitted a marketing authorisation application to the EMA for Zepzelca (lurbinectedin) in combination with ...
Posted by Michael Wonder on 21 May 2025
Moderna provides update on BLA submission for combination vaccine against influenza and COVID-19
21 May 2025 - Moderna today announced that in consultation with the US FDA, the Company has voluntarily withdrawn the ...
Posted by Michael Wonder on 17 May 2025
PharmaTher announces FDA extends review period for ketamine; new approval goal date 9 August 2025
16 May 2025 - PharmaTher today announced the US FDA has extended the approval goal date for the review of ...
Posted by Michael Wonder on 15 May 2025
FDA sets PDUFA date for Xspray Pharma’s re-submitted application for Dasynoc
14 May 2025 - The US FDA has acknowledged receipt of Xspray Pharma's re-submitted new drug application) for Dasynoc. ...
Posted by Michael Wonder on 15 May 2025
FDA extends PDUFA date of Biohaven's troriluzole NDA for rare disease spinocerebellar ataxia
14 May 2025 - Troriluzole would be the first and only FDA approved treatment for spinocerebellar ataxia, if approved. ...
Posted by Michael Wonder on 15 May 2025
BioCryst announces FDA acceptance of NDA for Orladeyo (berotralstat) oral granules in patients with hereditary angioedema aged 2 to 11 years
14 May 2025 - FDA grants priority review of application, with PDUFA target action date of 12 September 2025. ...
Posted by Michael Wonder on 13 May 2025
RegenxBio announces FDA acceptance and priority review of the BLA for RGX-121 for MPS II
13 May 2025 - FDA assigns PDUFA target action date of 9 November 2025. ...
Posted 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 04 May 2025
Health Canada accepts semaglutide 2.4 mg, a GLP-1 receptor agonist treatment for MASH, as a supplemental new drug submission under the priority review policy
2 May 2025 - Today, Novo Nordisk Canada announced that Health Canada has accepted for review, under the priority review policy, ...
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 ...