Blog
RSS FeedPosted by Michael Wonder on 13 Apr 2022
TGA approves Lumakras
13 April 2022 - Sotorasib is a Kirsten rat sarcoma (KRAS) G12C inhibitor, which covalently and irreversibly binds to the unique ...
Posted by Michael Wonder on 12 Apr 2022
US FDA grants fast track designation for Paradigm’s Phase 3 osteoarthritis program
12 April 2022 - Paradigm Biopharmaceuticals is pleased to announce that the U.S. FDA has granted fast track designation for ...
Posted by Michael Wonder on 12 Apr 2022
Health Canada has approved Zeposia (ozanimod), an oral treatment for adults with moderately to severely active ulcerative colitis
12 April 2022 - Zeposia is the first and only S1P receptor modulating agent approved for the treatment of ulcerative ...
Posted by Michael Wonder on 12 Apr 2022
Jardiance (empagliflozin) becomes the first and only approved treatment in Canada for adults with chronic heart failure regardless of ejection fraction
12 April 2022 - Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in ...
Posted by Michael Wonder on 12 Apr 2022
EMA and the EUnetHTA 21 consortium set priorities for their collaboration
12 April 2022 - The EMA and the European Network for Health Technology Assessment (EUnetHTA) 21 consortium have published a joint ...
Posted by Michael Wonder on 12 Apr 2022
Myovant Sciences and Pfizer provide update on supplemental new drug application for Myfembree for the management of moderate to severe pain associated with endometriosis
12 April 2022 - Myovant Sciences and Pfizer announced today an update on the Supplemental new drug application for Myfembree ...
Posted by Michael Wonder on 12 Apr 2022
Aeglea BioTherapeutics submits BLA to FDA for pegzilarginase for the treatment of arginase 1 deficiency
12 April 2022 - European marketing application on track for submission this year. ...
Posted by Michael Wonder on 12 Apr 2022
FDA grants Direct Biologics regenerative medicine advanced therapy designation for the use of ExoFlo in COVID-19 related ARDS
12 April 2022 - Direct Biologics announced that the U.S. FDA has awarded their EV drug product ExoFlo with a regenerative ...
Posted by Michael Wonder on 12 Apr 2022
TGA approves new medicine for patients with SLE
12 April 2022 - Anifrolumab is a human immunoglobulin G1 kappa monoclonal antibody that binds to subunit 1 of the type ...
Posted by Michael Wonder on 12 Apr 2022
It’s time to fix the FDA by breaking it up
11 April 2022 - A new investigation about the agency’s failures underscores the need for a separate agency to keep our ...
Posted by Michael Wonder on 12 Apr 2022
Recursion is granted fast track designation for REC-4881 for the potential treatment of familial adenomatous polyposis
11 April 2022 - Recursion today announced that the U.S. FDA has granted the company fast track designation for REC-4881 ...
Posted by Michael Wonder on 11 Apr 2022
Health Canada approves Gardasil 9 (human papillomavirus 9 valent vaccine, recombinant) for the prevention of oropharyngeal and other head and neck cancers
11 April 2022 - Gardasil 9 is the first vaccine in Canada approved for the prevention of HPV related oropharyngeal ...
Posted by Michael Wonder on 11 Apr 2022
A review of patient reported outcome labelling of FDA approved new drugs (2016-2020): counts, categories and comprehensibility
8 April 2022 - A review of new drug approvals by the U.S. FDA for 2006 to 2015 showed that approximately ...
Posted by Michael Wonder on 11 Apr 2022
Eton Pharmaceuticals announces FDA approval of cysteine hydrochloride injection
11 April 2022 - Eton Pharmaceuticals today announced that it has received final approval from the U.S. FDA for its cysteine ...
Posted by Michael Wonder on 11 Apr 2022
Poxel announces PXL770 awarded FDA fast track designation for X-linked adrenoleukodystrophy
11 April 2022 - Poxel is pleased to announce that the U.S. FDA has granted fast track designation to PXL770 ...