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RSS FeedPosted 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. ...
Posted by Michael Wonder on 26 Feb 2025
Pyxis Oncology granted FDA fast track designation for PYX-201 monotherapy in patients with recurrent or metastatic head and neck cancer
26 February 2025 - Pyxis Oncology today announced that the US FDA has granted fast track designation to PYX-201 for the ...
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 26 Feb 2025
GRIN Therapeutics receives FDA breakthrough therapy designation for radiprodil
25 February 2025 - Company preparing to initiate Phase 3 pivotal trial. ...
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 ...