Blog
RSS FeedPosted by Michael Wonder on 05 Mar 2025
Celltrion receives US FDA approval for Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo) biosimilars referencing Prolia and Xgeva
3 March 2025 - The FDA approval is based on robust clinical evidence, which show no clinically meaningful differences from the ...
Posted by Michael Wonder on 04 Mar 2025
Amneal’s BLA submissions for two denosumab biosimilars accepted for review by US FDA
3 March 2025 - Denosumab biosimilar candidates reference Prolia and Xgeva. ...
Posted by Michael Wonder on 04 Mar 2025
FDA files Corcept’s new drug application for relacorilant as treatment for patients with hypercortisolism
3 March 2025 - FDA assigns a PDUFA target action date of 30 December 2025. ...
Posted 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 03 Mar 2025
Latigo Biotherapeutics granted FDA fast track designation for LTG-001, potential best in class Nav1.8 inhibitor for the non-opioid treatment of acute pain
3 March 2025 - LTG-001 demonstrated favourable safety and tolerability profile with predictable pharmacokinetics in Phase 1 trial. ...
Posted by Michael Wonder on 03 Mar 2025
FDA approves Genentech’s TNKase in acute ischaemic stroke in adults
3 March 2025 - TNKase (tenecteplase) is the first stroke medicine approved by the FDA in nearly 30 years. ...
Posted by Michael Wonder on 03 Mar 2025
Supporting the development of drugs for rare diseases - the importance of regulatory transparency
1 March 2025 - Transparency regarding the information submitted to the FDA and the agency’s decision making could have far-reaching ...
Posted by Michael Wonder on 03 Mar 2025
Avobis Bio receives FDA fast track designation for AVB-114 implantable cell therapy for Crohn's perianal fistulas
27 February 2025 - Only implantable cell therapy for Crohn's perianal fistulas with FDA IND clearance and fast track designation. ...
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
FDA approves Odactra for the treatment of house dust mite allergy in young children
27 February 2025 - ALK today announced that the US FDA has approved ALK’s Odactra tablet for use in young children ...
Posted by Michael Wonder on 28 Feb 2025
ImmunityBio receives FDA RMAT designation for Anktiva and CAR-NK for the reversal of lymphopaenia in patients receiving standard of care chemotherapy/radiotherapy and in treatment of multiply relapsed locally advanced or metastatic pancreatic cancer
27 February 2025 - Regenerative medicine advanced therapy designation follows clinical data of absolute lymphocyte count and significant overall survival correlations ...
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 27 Feb 2025
BlueRock Therapeutics receives FDA fast track designation for OpCT-001 for the treatment of primary photoreceptor diseases
27 February 2025 - First iPSC-derived investigational cell therapy, OpCT-001, to be clinically tested for treating primary photoreceptor diseases. ...