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RSS FeedPosted by Michael Wonder on 20 Nov 2019
Newron receives FDA rare paediatric disease designation for sarizotan for the treatment of Rett syndrome
19 November 2019 - Newron announced today that the U.S. FDA has granted the rare paediatric disease designation for sarizotan, ...
Posted by Michael Wonder on 20 Nov 2019
Medexus granted priority review status for Gliolan by Health Canada
19 November 2019 - Medexus Pharmaceuticals today announced that Health Canada has granted priority review status for the new drug ...
Posted by Michael Wonder on 19 Nov 2019
European Medicines Agency grants Orchard Therapeutics accelerated assessment of OTL-200 for patients with metachromatic leukodystrophy
18 November 2019 - Orchard Therapeutics today announced that the CHMP of the EMA has granted an accelerated assessment for OTL-200, ...
Posted by Michael Wonder on 14 Nov 2019
Anavex Life Sciences receives rare paediatric disease designation from FDA for Anavex 2-73 (blarcamesine) for the treatment of Rett syndrome
14 November 2019 - Anavex Life Sciences today announced that it received the rare paediatric disease designation from the U.S. FDA ...
Posted by Michael Wonder on 14 Nov 2019
US FDA accepts regulatory submission for selumetinib in neurofibromatosis type 1 and grants priority review
14 November 2019 - AstraZeneca and MSD’s selumetinib would become the first medicine indicated for the treatment of paediatric patients with ...
Posted by Michael Wonder on 13 Nov 2019
Allergan receives FDA qualified infectious disease product designation and fast track designation for ATM-AVI (aztreonam and avibactam) for antibiotic-resistant gram-negative infections
11 November 2019 - FDA QIDP and fast track designations signify significant milestones in Allergan commitment to addressing unmet medical needs ...
Posted by Michael Wonder on 28 Oct 2019
CARsgen announces investigational CAR-T therapy CT053 granted RMAT designation by the U.S. FDA for relapsed/refractory multiple myeloma
28 October 2019 - CARsgen Therapeutics today announced that the United States FDA has granted regenerative medicine advanced therapy designation to ...
Posted 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 10 Oct 2019
Emergent BioSolutions receives EMA Prime Designation for its Chikungunya virus vaccine candidate
10 October 2019 - Emergent BioSolutions today announced that the company’s chikungunya virus (CHIKV) virus-like particle (VLP) vaccine candidate, CHIKV VLP, ...
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. ...