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RSS FeedPosted 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 ...
Posted by Michael Wonder on 25 Feb 2025
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus standard of care as peri-operative treatment for resectable locally advanced head and neck squamous cell carcinoma
25 February 2025 - Acceptance based on results from the KEYNOTE-689 trial: the first Phase 3 trial to demonstrate significant improvement ...
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 grants fast track designation to Coherent Biopharma’s CBP-1019
21 February 2025 - Coherent Biopharma announced that the US FDA has granted fast track designation to CBP-1019 for the treatment ...
Posted by Michael Wonder on 24 Feb 2025
Auron Therapeutics announces AUTX-703 granted fast track designation by the FDA for relapsed or refractory acute myelogenous leukaemia
24 February 2025 - Auron Therapeutics today announced that the US FDA has granted fast track designation to AUTX-703 for ...
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 23 Feb 2025
Luxa Biotechnology announces FDA regenerative medicine advanced therapy designation granted to RPESC-RPE-4W transplantation for the treatment of dry age-related macular degeneration
19 February 2025 - Luxa Biotechnology today announced that the US FDA has granted regenerative medicine advanced therapy designation to RPESC-RPE-4W ...