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RSS FeedPosted by Michael Wonder on 04 Nov 2021
OS Therapies receives rare paediatric disease designation in osteosarcoma for OST-HER2 (Listeria monocytogenes)
3 November 2021 - Pathway to priority review voucher and expedited review by the FDA. ...
Posted 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 31 Oct 2021
Novartis UK awarded Innovation Passport for investigational therapy
29 October 2021 - Novartis have announced that the investigational oral therapy, iptacopan (LNP023), has been awarded an Innovation Passport ...
Posted by Michael Wonder on 26 Oct 2021
Geron enters new innovative licensing and access pathway in the United Kingdom for imetelstat
25 October 2021 - Innovation Passport Designation Awarded to Imetelstat for the Treatment of Lower Risk Myelodysplastic Syndromes. ...
Posted by Michael Wonder on 18 Oct 2021
EMA grants PRIME designation for JR-141 for the treatment of mucopolysaccharidosis type II (Hunter syndrome)
18 October 2021 - JCR Pharmaceuticals announced today that the EMA has granted PRIME designation for the investigational drug JR-141 (pabinafusp ...
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 28 Sep 2021
European Medicines Agency grants Atara Biotherapeutics accelerated assessment of tab-cel for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease
27 September 2021 - Atara on track to submit MAA in November 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. ...