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RSS FeedPosted by Michael Wonder on 18 Jun 2025
Cancer inhibitors scrapped from basic insurance for some users
18 June 2025 - National health care institute Zorginstituut Nederland has scrapped several cancer inhibiting drugs from the basic health ...
Posted by Michael Wonder on 20 Dec 2023
European Commission approves Merck’s Keytruda (pembrolizumab) plus chemotherapy for new first-line indications in advanced HER2 negative gastric or GEJ adenocarcinoma in tumours expressing PD-L1 (CPS ≥1) and advanced biliary tract cancer
18 December 2023 - Keytruda now approved for 26 indications in the EU, including seven in gastro-intestinal cancers. ...
Posted by Michael Wonder on 19 Dec 2023
Catalyst Pharmaceuticals announces Firdapse new drug application submitted in Japan by partner DyDo Pharma
18 December 2023 - Catalyst Pharmaceuticals today announced that its collaboration partner, DyDo Pharma reported that it has submitted a new ...
Posted by Michael Wonder on 19 Dec 2023
The Government of Canada announces the creation of the Canadian Drug Agency
18 December 2023 - Helping make Canada's drug system more sustainable and better prepared for the future. ...
Posted by Michael Wonder on 19 Dec 2023
Artificial intelligence workplan to guide use of AI in medicines regulation
18 December 2023 - The EMA and the Heads of Medicines Agencies have published an artificial intelligence workplan to 2028, ...
Posted by Michael Wonder on 19 Dec 2023
Texas makes a stand against big pharma’s Covid vaccines
19 December 2023 - On the last day of November Texas launched extraordinary legal proceedings that could have wide-ranging political ...
Posted by Michael Wonder on 18 Dec 2023
Telix submits biologics license application for TLX250-CDx (Zircaix) for imaging of kidney cancer
19 December 2023 - Telix today announces that it has submitted its biologics license application to the United States US FDA ...
Posted by Michael Wonder on 18 Dec 2023
Lexeo Therapeutics granted FDA fast track designation and orphan drug designation for LX2020, an AAV based gene therapy candidate for PKP2 arrhythmogenic cardiomyopathy
18 December 2023 - Lexeo Therapeutics today announced the US FDA has granted fast track designation and orphan drug designation to ...
Posted by Michael Wonder on 18 Dec 2023
AnHeart Therapeutics and Innovent Announce China’s NMPA has granted taletrectinib (ROS1 inhibitor) priority review designation
18 December 2023 -AnHeart Therapeutics and Innovent Biologics today announced the Center for Drug Evaluation of China’s National Medical Products ...
Posted by Michael Wonder on 18 Dec 2023
GC Biopharma announces US FDA approval for Alyglo (immune globulin intravenous, human-stwk) 10% liquid for adults with primary humoral immunodeficiency
18 December 2023 - - GC Biopharma today announces that the US FDA has approved Alyglo (immune globulin intravenous, human-stwk) 10% ...
Posted by Michael Wonder on 18 Dec 2023
EndeavorRx, world’s first and only prescription video game treatment, secures FDA label expansion for paediatric ADHD patients aged 13-17
18 December 2023 - Akili’s clinically proven digital medicine now authorised for children 8-17, opening option to more patients as ...
Posted by Michael Wonder on 18 Dec 2023
Zai Lab announces the first listing of Vyvgart (efgartigimod alfa) and other updates in China’s National Reimbursement Drug List
12 December 2023 - Zai Lab today announced that the 2023 National Reimbursement Drug List (NRDL) released by China’s National Healthcare ...
Posted by Michael Wonder on 18 Dec 2023
US FDA issues complete response letter for cosibelimab solely due to inspection findings at third party manufacturer
18 December 2023 - FDA did not state any concerns about the clinical data package, safety, or labeling for the approvability ...
Posted by Michael Wonder on 18 Dec 2023
Leo Pharma announces US FDA approval of Adbry (tralokinumab-ldrm) for the treatment of moderate to severe atopic dermatitis in paediatric patients aged 12-17 years
15 December 2023 - In the ECZTRA 6 trial, significantly more paediatric patients met the primary and key secondary endpoints of ...
Posted by Michael Wonder on 18 Dec 2023
EMA gives positive opinion to Fexinidazole Winthrop as first oral treatment of acute form of sleeping sickness (rhodesiense) found in East and Southern Africa
15 December 2023 - EMA gives positive opinion to Fexinidazole Winthrop as first oral treatment of acute form of sleeping ...
Posted by Michael Wonder on 18 Dec 2023
CHMP issues positive opinion for Biogen’s Skyclarys (omaveloxolone), the first therapy to treat Friedreich’s ataxia, a rare neurodegenerative disease
15 December 2023 - Biogen announced the CHMP of the EMA recommended marketing authorisation for Skyclarys (omaveloxolone) for the treatment ...