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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 04 Nov 2021
Lipocine announces FDA grants fast track designation to LPCN 1144 for treatment of non-cirrhotic NASH
4 November 2021 - Lipocine today announced that the U.S. FDA has granted fast track designation to LPCN 1144 as a ...
Posted by Michael Wonder on 04 Nov 2021
UNION therapeutics receives FDA fast track designation for oral orismilast for the treatment of moderate to severe atopic dermatitis
4 November 2021 - FDA's fast track designation for oral orismilast underscores the urgent need for new treatment option with potential ...
Posted by Michael Wonder on 04 Nov 2021
Epizyme receives fast track designation from U.S. FDA and announces initiation of Phase 1/1b study of its novel SETD2 inhibitor, EZM0414
4 November 2021 - Epizyme today announced that the U.S. FDA has granted fast track designation to EZM0414, the Company’s novel, ...
Posted by Michael Wonder on 04 Nov 2021
TecTraum’s pro2cool receives FDA designation as a breakthrough device for the treatment of concussions
3 November 2021 - TecTraum today announced that the U.S. FDA has designated its flagship technology, pro2cool, as a breakthrough ...
Posted by Michael Wonder on 04 Nov 2021
Funding hole makes cracking COVID-19 vaccine code a tougher ask
4 November 2021 - Australia has the expertise to crack the code in the biggest challenge facing the COVID-19 vaccination ...
Posted by Michael Wonder on 04 Nov 2021
COVID-19 vaccine weekly safety report (4 November 2021)
4 November 2021 - To 31 October 2021, the TGA has received 253 reports which have been assessed as likely to ...
Posted by Michael Wonder on 03 Nov 2021
Trastuzumab deruxtecan type II variation application validated by EMA for the treatment of HER2 positive advanced gastric cancer
3 November 2021 - Application based on DESTINY-Gastric01 and DESTINY-Gastric02 phase 2 trials. ...
Posted by Michael Wonder on 03 Nov 2021
TransThera receives fast track designation from FDA for its core product TT-00420 to treat cholangiocarcinoma
3 November 2021 - TransThera Sciences announced that the U.S. FDA has granted fast track designation to its phase II ...
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 03 Nov 2021
Allena Pharmaceuticals receives fast track designation from FDA for the development of ALLN-346 for chronic treatment of hyperuricemia in patients with gout and advanced chronic kidney disease
3 November 2021 - Novel oral therapeutic candidate ALLN-346 targets uric acid in the intestinal tract. ...
Posted by Michael Wonder on 03 Nov 2021
Opdivo receives two new Health Canada approvals
2 November 2021 - Today Bristol Myers Squibb Canada announces two recent Health Canada approvals for Opdivo (nivolumab). ...
Posted by Michael Wonder on 03 Nov 2021
Health Canada issues Notice of Compliance for Jardiance (empagliflozin) for the treatment of heart failure with reduced ejection fraction
2 November 2021 - This new indication is based on the EMPEROR-Reduced trial, which showed a significant 25% reduction in the ...
Posted by Michael Wonder on 03 Nov 2021
Amylyx Pharmaceuticals submits new drug application for AMX0035 for the treatment of ALS
2 November 2021 - Amylyx Pharmaceuticals today announced it has submitted a new drug application to the U.S. FDA for AMX0035 ...
Posted by Michael Wonder on 02 Nov 2021
FDA grants breakthrough status for Alzheimer's treatment
2 November 2021 - Renew Bioscience announced it has received breakthrough device designation status from the U.S. FDA for the ...