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RSS FeedPosted by Michael Wonder on 17 Oct 2019
Trastuzumab deruxtecan (DS-8201) granted FDA priority review for treatment of patients with HER2 positive metastatic breast cancer
17 October 2019 - Daiichi Sankyo and AstraZeneca today announced that the U.S. FDA has accepted for review the biologics ...
Posted by Michael Wonder on 16 Oct 2019
ProQR receives rare paediatric disease designation from FDA for sepofarsen for the treatment of LCA10
15 October 2019 - ProQR Therapeutics today announced that it received rare paediatric disease designation from the U.S. FDA for ...
Posted by Michael Wonder on 09 Oct 2019
Vast Therapeutics receives qualified infectious disease product status for BIOC11
8 October 2019 - Vast Therapeutics today announced that another of its drug candidates, BIOC11, has been designated as a ...
Posted by Michael Wonder on 01 Oct 2019
Fees for redeeming priority review vouchers fall to all-time low in FY2020
30 September 2019 - The US FDA on Friday announced the fees for using a priority review voucher to speed ...
Posted by Michael Wonder on 24 Sep 2019
FDA grants paediatric disease designation for Mateon's OT101
23 September 2019 - For treatment of diffuse intrinsic pontine glioma, a difficult to treat form of childhood brain tumour. ...
Posted 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. ...