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RSS FeedPosted by Michael Wonder on 07 Dec 2024
FDA grants accelerated approval to zenocutuzumab-zbco for non-small cell lung cancer and pancreatic adenocarcinoma
4 December 2024 - This represents the first FDA approval of a systemic therapy for patients with non-small cell lung cancer ...
Posted by Michael Wonder on 07 Dec 2024
PIF Partners granted FDA rare paediatric disease designation for its proprietary small molecule in treating systemic juvenile idiopathic arthritis flares
3 December 2024 - PIF Partners announced today that the US FDA has granted rare paediatric disease designation to its proprietary ...
Posted by Michael Wonder on 07 Dec 2024
Saol Therapeutics announces submission of new drug application to the US FDA for SL1009
3 December 2024 - Saol Therapeutics today announced the submission of a new drug application to the US FDA for approval ...
Posted by Michael Wonder on 07 Dec 2024
Lantern Pharma's investigational drug candidate, LP-184, receives second fast track designation from FDA for treatment of triple negative breast cancer
3 December 2024 - LP-184 has demonstrated significant pre-clinical efficacy in triple negative breast cancer models, including those resistant to PARP ...
Posted by Michael Wonder on 07 Dec 2024
FDA grants fast track designation to CRB-701 for the treatment of relapsed or refractory metastatic cervical cancer
3 December 2024 - Corbus Pharmaceuticals announced today that the US FDA has granted fast track designation to CRB-701 for the ...
Posted by Michael Wonder on 07 Dec 2024
US FDA approves Biocon Biologics' Yesintek biosimilar to J&J's Stelara (ustekinumab)
2 December 2024 - Biocon Biologics announced today that the US FDA has approved Yesintek (ustekinumab-kfce), a biosimilar to the ...
Posted by Michael Wonder on 06 Dec 2024
Rigel announces R289 granted fast track designation by the FDA for lower risk myelodysplastic syndrome
2 December 2024 - Rigel Pharmaceuticals today announced that the US FDA has granted fast track designation to R289 for the ...
Posted by Michael Wonder on 06 Dec 2024
FDA grants breakthrough therapy designation to sacituzumab tirumotecan for the treatment of certain patients with previously treated advanced or metastatic non-squamous non-small cell lung cancer with EGFR mutations
3 December 2024 - First breakthrough therapy designation for investigational sac-TMT in the US. ...
Posted 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 ...