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RSS FeedPosted by Michael Wonder on 29 Sep 2021
Global disparity in access to novel therapeutics for metastatic prostate cancer
29 September 2021 - Access to androgen receptor directed therapies, which also have life-prolonging benefits in the castration-resistant prostate cancer ...
Posted by Michael Wonder on 29 Sep 2021
TransMedics receives FDA approval for its OCS Liver System for preservation and assessment of donor livers for transplantation
29 September 2021 - TransMedics today announced that the U.S. FDA has granted pre-market approval of its OCS Liver System ...
Posted by Michael Wonder on 29 Sep 2021
Benefit-risk assessment for new drug and biological products
29 September 2021 - The intent of this guidance is to clarify for drug sponsors and other stakeholders how considerations about ...
Posted by Michael Wonder on 29 Sep 2021
Helsinn Group and BridgeBio Pharma’s affiliate QED Therapeutics announce Health Canada conditional approval of Truseltiq (infigratinib) for patients with cholangiocarcinoma
29 September 2021 - Health Canada issues conditional approval of Truseltiq under Project Orbis (27 September 2021). ...
Posted by Michael Wonder on 29 Sep 2021
NuCana receives fast track designation from the U.S. Food and Drug Administration for Acelarin (NUC-1031) for the treatment of biliary tract cancer
29 September 2021 - NuCana announced that the U.S. FDA has granted fast track designation to Acelarin (NUC-1031), currently being evaluated ...
Posted by Michael Wonder on 29 Sep 2021
U.S. FDA approves Livmarli (maralixibat) as the first and only approved medication for the treatment of cholestatic pruritus in patients with Alagille syndrome one year of age and older
29 September 2021 - Mirum Pharmaceuticals today announced that the U.S. FDA has approved Livmarli (maralixibat) oral solution for the treatment ...
Posted by Michael Wonder on 29 Sep 2021
U.S. FDA accepts filings for Amicus’ AT-GAA for the treatment of Pompe disease
29 September 2021 - FDA sets PDUFA target action date of 29 May 2022 for the new drug application and 29 ...
Posted by Michael Wonder on 29 Sep 2021
EMA implements new measures to minimise animal testing during medicines development
29 September 2021 - EMA is putting in place special support to developers to replace, reduce and refine animal use for ...
Posted by Michael Wonder on 29 Sep 2021
Nonagen Bioscience granted FDA breakthrough device designation
28 September 2021 - Nonagen Bioscience today announced Oncuria, their non-invasive bladder cancer test capable of predicting response to therapy, has ...
Posted by Michael Wonder on 29 Sep 2021
Selux Diagnostics earns FDA breakthrough device designation for next generation phenotyping platform for positive blood culture and sterile body fluid samples
28 September 2021 - Selux next generation phenotyping now qualifies for expedited FDA review process as single-platform technology for rapid antimicrobial ...
Posted by Michael Wonder on 29 Sep 2021
Novian Health gains FDA breakthrough designation for Novilase breast therapy
28 September 2021 - Novian Health has been granted breakthrough device designation from the U.S. FDA for its Novilase Interstitial Laser ...
Posted by Michael Wonder on 29 Sep 2021
FDA approves Qulipta (atogepant), the first and only oral CGRP receptor antagonist specifically developed for the preventive treatment of migraine
27 September 2021 - Qulipta demonstrated statistically significant, clinically meaningful rapid and continuous reductions in mean monthly migraine days among adults ...
Posted by Michael Wonder on 29 Sep 2021
FDA expands Lilly's Erbitux (cetuximab) label with combination of Braftovi (encorafenib) for the treatment of BRAF V600E mutation positive metastatic colorectal cancer after prior therapy
28 September 2021 - Erbitux is the first and only anti-EGFR antibody approved, in combination with encorafenib, specifically for adults ...
Posted by Michael Wonder on 28 Sep 2021
Pfizer and BionNTech submit initial data to U.S. FDA from pivotal trial of COVID-19 vaccine in children 5 to <12 years of age
28 September 2021 - Formal submission to request Emergency Use Authorization to follow in the coming weeks. ...
Posted by Michael Wonder on 28 Sep 2021
TGA grants provisional determination to Roche COVID-19 treatment tocilizumab (Actemra)
28 September 2021 - On 27 September 2021, the TGA granted provisional determination to Roche in relation to the COVID-19 ...