Blog
RSS FeedPosted by Michael Wonder on 06 Dec 2024
Johnson & Johnson seeks US FDA approval for first paediatric indications for Tremfya (guselkumab)
2 December 2024 - Applications filed for Tremfya to treat children with moderate to severe plaque psoriasis and active juvenile psoriatic ...
Posted by Michael Wonder on 06 Dec 2024
Sana Biotechnology announces fast track designation for SC291 in relapsed/refractory systemic lupus erythematosus
2 December 2025 - Enrolling patients in the GLEAM trial for SC291 in B-cell mediated auto-immune diseases, including systemic lupus erythematosus; ...
Posted by Michael Wonder on 06 Dec 2024
US FDA approves StemCyte biologics license application for Regenecyte cord blood cell therapy product
22 November 2024 - StemCyte announced today that the US FDA has approved the Biologics License Application for its HPC, cord ...
Posted by Michael Wonder on 05 Dec 2024
Clearing dense drug patent thickets
27 November 2024 - Proposed reforms from the US Patent and Trademark Office and Congress could work in tandem to prevent ...
Posted by Michael Wonder on 05 Dec 2024
Applied Therapeutics receives complete response letter from US FDA regarding new drug application for govorestat for classic galactosaemia
27 November 2024 - Applied Therapeutics today announced that the US FDA has issued a complete response letter for the ...
Posted by Michael Wonder on 05 Dec 2024
Lin BioScience receives US FDA fast track designation for LBS-007
27 November 2024 - A Phase 1/2 trial in patients with relapsed or resistant acute leukaemias is on-going. ...
Posted by Michael Wonder on 05 Dec 2024
Exelixis provides regulatory update related to supplemental new drug application for cabozantinib (Cabometyx) for the treatment of patients with previously treated advanced neuroendocrine tumors
26 November 2024 - 26, 2024-- Exelixis today announced that the US FDA has notified the company that the supplemental new ...
Posted by Michael Wonder on 04 Dec 2024
Satsuma Pharmaceuticals and SNBL receive FDA acceptance of NDA resubmission of STS101 for the acute treatment of migraine with or without aura
26 November 2024 - Satsuma Pharmaceuticals and its corporate parent Shin Nippon Biomedical Laboratories are pleased to announce that the ...
Posted by Michael Wonder on 04 Dec 2024
Theratechnologies submits updated tesamorelin F8 formulation sBLA for FDA review
26 November 2024 - Resubmission addresses questions raised in January 2024 complete response letter. ...
Posted by Michael Wonder on 04 Dec 2024
Valneva submits label extension application for its Chikungunya vaccine, Ixchiq, to the US FDA
26 November 2024 - To potentially include adolescents and antibody persistence up to two years. ...
Posted by Michael Wonder on 04 Dec 2024
Soleno Therapeutics announces FDA extension of review period for DCCR (diazoxide choline) extended release tablets in Prader-Willi syndrome
26 November 2024 - PDUFA target action date extended by three months to 27 March 2025. ...
Posted by Michael Wonder on 04 Dec 2024
Alnylam announces US FDA acceptance of supplemental new drug application for vutrisiran for the treatment of ATTR amyloidosis with cardiomyopathy
25 November 2024 - PDUFA date set for 23 March 2025. ...
Posted by Michael Wonder on 03 Dec 2024
Intellia Therapeutics announces FDA regenerative medicine advanced therapy designation granted to nexiguran ziclumeran for the treatment of hereditary transthyretin amyloidosis with polyneuropathy
25 November 2024 - Intellia Therapeutics today announced that the US FDA has granted regenerative medicine advanced therapy designation to nexiguran ...
Posted by Michael Wonder on 03 Dec 2024
Preferences for speed of access versus certainty of the survival benefit of new cancer drugs: a discrete choice experiment
18 November 2024 - The extent to which patients with cancer are willing to accept uncertainty about the clinical benefit of ...
Posted by Michael Wonder on 03 Dec 2024
The trade-off between accelerated cancer drug approvals and patient preferences
18 November 2024 - Cancer care stands at a critical juncture where the urgency of rapid drug approvals must be balanced ...