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RSS FeedPosted by Michael Wonder on 03 Nov 2021
AvroBio receives rare paediatric disease designation from the U.S. FDA for AVR-RD-05, a gene therapy for mucopolysaccharidosis type II or Hunter syndrome
3 November 2021 - AVROBIO today announced that the U.S. FDA has granted rare paediatric disease designation to AVR-RD-05, its ...
Posted by Michael Wonder on 02 Nov 2021
Junshi Biosciences and Coherus announce FDA acceptance of BLA filing for toripalimab for treatment of nasopharyngeal carcinoma
1 November 2021 - FDA has granted the toripalimab BLA Priority Review with a target action date of April 2022. ...
Posted by Michael Wonder on 12 Oct 2021
Y-mAbs’ 177Lu-omburtamab-DTPA for the treatment of patients with medulloblastoma granted rare paediatric disease designation by FDA
7 October 2021 - Y-mAbs Therapeutics today announced that the U.S. FDA has granted rare paediatric disease designation for the Company’s ...
Posted by Michael Wonder on 30 Sep 2021
FDA grants priority review for investigational targeted radioligand therapy 177Lu-PSMA-617 for patients with metastatic castration-resistant prostate cancer
28 September 2021 - Novartis announced today that the US FDA has accepted and granted Priority Review to the company’s New ...
Posted by Michael Wonder on 28 Sep 2021
FDA grants priority review to ViiV Healthcare’s new drug application for cabotegravir long-acting for prevention of HIV
28 September 2021 - Final FDA decision anticipated by 24 January 2022; if approved, cabotegravir would be the first long-acting ...
Posted by Michael Wonder on 28 Sep 2021
FDA accepts Libtayo (cemiplimab-rwlc) for priority review for advanced cervical cancer
28 September 2021 - European Union regulatory submission planned by end of 2021. ...
Posted by Michael Wonder on 20 Sep 2021
Marinus Pharmaceuticals announces FDA acceptance for filing and priority review of new drug application for ganaxolone in CDKL5 deficiency disorder
20 September 2021 - FDA indicated that it is not currently planning to hold an advisory committee meeting for the ...
Posted by Michael Wonder on 15 Sep 2021
Pulmocide’s lead drug candidate opelconazole (PC945) granted orphan drug, fast track and qualified infectious disease product designations by US FDA
15 September 2021 - Pulmocide today announced that the US FDA has granted orphan drug, fast track and qualified infectious disease ...
Posted by Michael Wonder on 10 Sep 2021
Decibel Therapeutics receives orphan drug and rare paediatric disease designations for DB-OTO for the treatment of otoferlin related congenital hearing loss
9 September 2021 - Decibel Therapeutics today announced that the U.S. FDA has granted both orphan drug designation and rare paediatric ...
Posted by Michael Wonder on 09 Sep 2021
Albireo sells priority review voucher for $105 million
7 September 2021 - PRV was granted to Albireo with the FDA approval of Bylvay (odevixibat) in July. ...
Posted by Michael Wonder on 25 Aug 2021
FDA accelerates review of Novartis STAMP inhibitor asciminib (ABL001) for patients with chronic myeloid leukaemia
25 August 2021 - Novartis today announced that the US FDA accepted and granted priority review to the company’s new drug ...
Posted by Michael Wonder on 23 Aug 2021
U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for Orencia (abatacept) for the prevention of acute graft versus host disease
23 August 2021 - The sBLA is supported by the Phase 2 ABA2 trial evaluating Orencia in adults and children to ...
Posted by Michael Wonder on 10 Aug 2021
Liminal BioSciences announces sale of priority review voucher for USD105 million
9 August 2021 - Liminal BioSciences announced today that its subsidiary ProMetic Biotherapeutics has entered into a definitive agreement to ...
Posted by Michael Wonder on 09 Aug 2021
Daré Bioscience announces FDA acceptance and priority review of new drug application for DARE-BV1 for the treatment of bacterial vaginosis
9 August 2021 - New drug application supported by positive data from the DARE-BVFREE Phase 3 study, which demonstrated clinical cure ...
Posted by Michael Wonder on 08 Aug 2021
US tropical disease priority review vouchers: lessons in promoting drug development and access
6 August 2021 - The COVID-19 global pandemic has devastated lives and economies. It has served as a reminder of how ...