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RSS FeedPosted by Michael Wonder on 12 Jan 2021
U.S. FDA grants priority review to new drug application for finerenone to treat patients with chronic kidney disease and type 2 diabetes mellitus
12 January 2021 - Bayer announced today that the U.S. FDA has accepted its new drug application and granted priority review ...
Posted by Michael Wonder on 11 Jan 2021
Organogenesis ReNu receives FDA regenerative medicine advanced therapy designation for osteoarthritis of the knee
11 January 2021 - FDA determines ReNu preliminary clinical evidence indicates potential to address unmet medical needs for the management of ...
Posted by Michael Wonder on 08 Jan 2021
Praxis Precision Medicines receives rare paediatric disease and orphan drug designations for severe paediatric epilepsy programs
7 January 2021 - FDA grants RPD and ODD for PRAX-222 for treatment of SCN2A-DEE. ...
Posted by Michael Wonder on 08 Jan 2021
Inversago Pharma receives rare paediatric disease designation from the FDA for INV-101 for the treatment of Prader-Willi syndrome
7 January 2021 - Inversago Pharma today announced the U.S. FDA granted a rare paediatric disease designation to the Company’s lead ...
Posted by Michael Wonder on 06 Jan 2021
FDA accepts for priority review the new drug application for mirabegron for oral suspension and supplemental new drug application for Myrbetriq (mirabegron) tablets in paediatric patients
6 January 2021 - Astellas Pharma announced today that the U.S. FDA accepted priority review for its new drug application for ...
Posted by Michael Wonder on 06 Jan 2021
Farxiga granted priority review in the US for the treatment of patients with chronic kidney disease
6 January 2021 - Farxiga could become the first SGLT2 inhibitor approved to treat patients with chronic kidney disease, with ...
Posted by Michael Wonder on 01 Jan 2021
CytRx issues statement regarding U.S. regulatory review of arimoclomol for Niemann-Pick disease type C
31 December 2020 - CytRx today provided an update on the U.S. FDA review of Orphazyme new drug application for arimoclomol ...
Posted by Michael Wonder on 29 Dec 2020
Y-mAbs announces sale of priority review voucher
28 December 2020 - Y-mAbs Therapeutics today announced that it has entered into a definitive agreement to sell its priority ...
Posted by Michael Wonder on 26 Dec 2020
Novadip Biosciences receives rare paediatric disease priority review and orphan disease designation
23 December 2020 - Novadip Biosciences today announces that the U.S. FDA has granted rare paediatric disease designation and Orphan Drug ...
Posted by Michael Wonder on 21 Dec 2020
Sesen Bio submits completed biologics license application to the FDA for Vicineum and has requested priority review
21 December 2020 - BLA supported by strong Phase 3 VISTA trial data and positive analytical comparability data. ...
Posted by Michael Wonder on 17 Dec 2020
Novartis investigational oral therapy iptacopan (LNP023) receives FDA breakthrough therapy designation for PNH and rare paediatric disease designation for C3G
16 December 2020 - Iptacopan is in development for paroxysmal nocturnal haemoglobinuria, as well as C3 glomerulopathy and several other ...
Posted by Michael Wonder on 17 Dec 2020
FDA grants RMAT designation for Cook MyoSite’s investigational autologous muscle derived cells for urinary sphincter repair
17 December 2020 - Cook MyoSite today announced that the U.S. FDA has granted the regenerative medicine advanced therapy designation to ...
Posted by Michael Wonder on 15 Dec 2020
U.S. FDA accepts new drug application for review, grants priority review for Takeda’s TAK-721 (budesonide oral suspension) for the treatment of eosinophilic oesophagitis
15 December 2020 - If approved, TAK-721 will be the first FDA approved treatment for the chronic inflammatory disease; Takeda plans ...
Posted by Michael Wonder on 10 Dec 2020
X4 Pharmaceuticals receives rare paediatric disease designation from FDA for mavorixafor for the treatment of WHIM syndrome
10 December 2020 - X4 Pharmaceuticals today announced that it has received rare paediatric disease designation from the U.S. FDA ...
Posted by Michael Wonder on 09 Dec 2020
US FDA accepts for priority review the biologics license application for Pfizer’s investigational 20 valent pneumococcal conjugate vaccine for adults 18 years of age and older
8 December 2020 - If approved, the vaccine will help protect adults against 20 serotypes responsible for the majority of invasive ...