Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 20 Dec 2023
Chiesi Global Rare Diseases receives FDA approval for Filzuvez (birch triterpenes) topical gel for the treatment of epidermolysis bullosa
19 December 2023 - Filzuvez was well tolerated and met the primary outcome with statistical significance, with 41.3% of patients ...
Posted by Michael Wonder on 20 Dec 2023
Budesonide for the treating primary IgA nephropathy
20 December 2023 - NICE has published evidence-based recommendations on the use of budesonide (Kinpeygo) for the treatment of adults ...
Posted by Michael Wonder on 20 Dec 2023
Ravulizumab for the treatment of patients with generalised myasthenia gravis
20 December 2023 - NICE is unable to make a recommendation on the use of ravulizumab (Ultomiris) for the treatment of ...
Posted by Michael Wonder on 20 Dec 2023
Ocugen announces OCU400 receives regenerative medicine advanced therapy designation for treatment of retinitis pigmentosa associated with RHO mutations
19 December 2023 - Ocugen today announced that the FDA has granted regenerative medicine advanced therapy designation to Ocugen’s investigational product ...
Posted by Michael Wonder on 20 Dec 2023
FDA grants priority review to Xolair (omalizumab) for children and adults with food allergies based on positive National Institutes of Health Phase 3 study results
19 December 2023 - Interim analysis results from first of its kind Phase 3 OUtMATCH study showed Xolair significantly increased the ...
Posted by Michael Wonder on 20 Dec 2023
FDA grants priority review to Merck’s new biologics license application for V116, an investigational, 21 valent pneumococcal conjugate vaccine specifically designed to protect adults
19 December 2023 - The 21 serotypes covered by V116 are responsible for approximately 83% of invasive pneumococcal disease in ...
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% ...