Blog
RSS FeedPosted by Michael Wonder on 20 Sep 2019
SanBio granted regenerative medicine advanced therapy designation from the U.S. FDA for SB623 for the treatment of chronic neurological motor deficits secondary to traumatic brain injury
19 September 2019 - The SanBio Group today announced that the U.S. FDA has granted regenerative medicine advanced therapy designation ...
Posted by Michael Wonder on 17 Sep 2019
FDA accepts Merck’s biologics license application and grants priority review for V920, the company’s investigational vaccine for Ebola Zaire virus
17 September 2019 - Merck continues to expand investigational supply to support international Ebola outbreak response. ...
Posted by Michael Wonder on 16 Sep 2019
Seattle Genetics and Astellas announce U.S. FDA grants priority review for enfortumab vedotin biologics license application in locally advanced or metastatic urothelial cancer
16 September 2019 - FDA sets Prescription Drug User Fee action date for 15 March 2020. ...
Posted by Michael Wonder on 10 Sep 2019
Horizon Therapeutics announces the FDA has granted priority review of the teprotumumab biologics license application for the treatment of active thyroid eye disease
9 September 2019 - If approved, teprotumumab would be the first FDA approved medicine for this vision-threatening disease. ...
Posted by Michael Wonder on 05 Sep 2019
GBT announces U.S. FDA acceptance of new drug application and priority review for voxelotor for the treatment of sickle cell disease
5 September 2019 - NDA supported by data from Phase 3 HOPE study, which demonstrated statistically significant and sustained improvements in ...
Posted by Michael Wonder on 04 Sep 2019
Magenta Therapeutics announces FDA regenerative medicine advanced therapy designation granted to MGTA-456 for the treatment of inherited metabolic disorders
4 September 2019 - Magenta Therapeutics today announced that the U.S. FDA granted regenerative medicine advanced therapy designation for MGTA-456, ...
Posted by Michael Wonder on 04 Sep 2019
GeneTx and Ultragenyx announce orphan drug designation and rare paediatric disease designation for GTX-102
3 September 2019 - GeneTx Biotherapeutics and Ultragenyx today announced that the U.S. FDA has granted orphan drug designation and rare ...
Posted by Michael Wonder on 22 Aug 2019
AstraZeneca agrees to buy US FDA priority review voucher from Sobi
22 August 2019 - AstraZeneca today announced that it has agreed to buy a US FDA priority review voucher for ...
Posted by Michael Wonder on 22 Aug 2019
U.S. FDA grants Xtandi (enzalutamide) application priority review for the treatment of men with metastatic hormone-sensitive prostate cancer
21 August 2019 - Xtandi supplemental new drug application seeks to add an indication for men with prostate cancer that has ...
Posted by Michael Wonder on 12 Aug 2019
Daré Bioscience receives QIDP designation from the FDA for DARE-BV1 for the treatment of bacterial vaginosis
12 August 2019 - DARE-BV1 Phase 3 registrational trial initiation expected in 4th quarter 2019. ...
Posted by Michael Wonder on 05 Aug 2019
Alnylam announces U.S. FDA granted priority review of the givosiran new drug application for the treatment of acute hepatic porphyria
5 August 2019 - PDUFA date set for 4 February 2020. ...
Posted by Michael Wonder on 01 Aug 2019
Fast track pathways for drug approvals: the Australian experience so far
1 August 2019 - In 2016, the Australian Government announced that the Therapeutic Goods Administration would establish two new pathways ...
Posted by Michael Wonder on 31 Jul 2019
Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies)
31 July 2019 - EMA and the US FDA have published today a report on their joint workshop with stakeholders ...
Posted by Michael Wonder on 30 Jul 2019
Novartis’ Zolgensma joins growing list of medicines to lose accelerated assessment status in EU
29 July 2019 - The EMA's CHMP recently announced its decision to remove Novartis’ spinal muscular atrophy gene therapy onasemnogene ...
Posted by Michael Wonder on 30 Jul 2019
EMA grants PRIME access to ProQR’s sepofarsen for Leber’s congenital amaurosis 10
29 July 2019 - Access based on positive interim analysis of clinical data as well as preclinical data to date. ...