Blog
RSS FeedPosted by Michael Wonder on 04 Mar 2025
Depemokimab applications accepted for review by the US FDA for asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps
3 March 2025 - Submissions based on data from positive SWIFT and ANCHOR trials. ...
Posted by Michael Wonder on 02 Mar 2025
Teva and Medincell announce FDA acceptance of supplemental new drug application for Uzedy (risperidone) extended release injectable suspension as a treatment for patients with bipolar I disorder
25 February 2025 - Uzedy is currently approved in the US as a subcutaneous long-acting injectable for use every one or ...
Posted by Michael Wonder on 01 Mar 2025
Outlook Therapeutics resubmits biologics license application for ONS-5010 as a treatment for wet AMD to the US FDA
28 February 2025 - Outlook Therapeutics today announced it has re-submitted its biologics license application to the US FDA for ...
Posted by Michael Wonder on 28 Feb 2025
US FDA grants priority review to Sobi's supplemental biologics licence application for Gamifant (emapalumab-lzsg)
27 February 2025 - Sobi today announced that the US FDA has accepted the supplemental biologics license application for Gamifant (emapalumab-Izsg) ...
Posted by Michael Wonder on 27 Feb 2025
FDA accepts BLA for TLX250-CDx (Zircaix) for kidney cancer imaging, grants priority review
26 February 2025 - Telix today announces that the US FDA has accepted the biologics license application for its breakthrough investigational ...
Posted by Michael Wonder on 26 Feb 2025
Opus Genetics announces FDA fast track and enrollment updates for phentolamine ophthalmic solution 0.75% programs
26 February 2025 - Enrollment completion in LYNX-2 pivotal Phase 3 trial expected in first half of 2025. ...
Posted by Michael Wonder on 26 Feb 2025
Odronextamab BLA accepted for FDA review for the treatment of relapsed/refractory follicular lymphoma
26 February 2025 - FDA decision expected by 30 July 2025. ...
Posted by Michael Wonder on 25 Feb 2025
FDA grants priority review to Precigen's BLA for PRGN-2012 for the treatment of adults with recurrent respiratory papillomatosis with PDUFA target action date set for 27 August 2025
25 February 2025 - If approved, PRGN-2012 would be the first and only available FDA approved therapy for eligible patients ...
Posted by Michael Wonder on 25 Feb 2025
Glaukos announces FDA acceptance of NDA submission for Epioxa
24 February 2025 - PDUFA date set for 20 October 2025. ...
Posted by Michael Wonder on 24 Feb 2025
US FDA accepts BMS’s supplemental biologics license application for Opdivo plus Yervoy for patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer
24 February 2025 - Application based on analyses from the Phase 3 CheckMate-8HW clinical trial, in which Opdivo plus Yervoy demonstrated ...
Posted by Michael Wonder on 21 Feb 2025
Alvotech and Teva announce filing acceptance of US biologics license application for AVT06, a proposed biosimilar to Eylea (aflibercept)
18 February 2025 - Alvotech and Teva Pharmaceuticals today announced that the US FDA has accepted for review a biologics license ...
Posted by Michael Wonder on 21 Feb 2025
FDA approves first treatment for cerebrotendinous xanthomatosis, a rare lipid storage disease
21 February 2025 - Today, the US FDA approved Ctexli (chenodiol) for the treatment of cerebrotendinous xanthomatosis in adults. ...
Posted by Michael Wonder on 20 Feb 2025
Harmony Biosciences provides update on the status of the supplemental new drug application for pitolisant in idiopathic hypersomnia
19 February 2025 - Harmony Biosciences today announced that it received a refusal to file letter from the US FDA for ...
Posted by Michael Wonder on 20 Feb 2025
PTC Therapeutics announces FDA acceptance and priority review for vatiquinone NDA for the treatment of children and adults with Friedreich's ataxia
19 February 2025 - PDUFA target action date of 19 August 2025. ...
Posted by Michael Wonder on 20 Feb 2025
Boehringer’s zongertinib receives priority review from US FDA for the treatment of HER2 (ERBB2)-mutant advanced non-small cell lung cancer
19 February 2025 - The application for this investigational treatment is based on positive results from the Phase Ib Beamion LUNG-1, ...