Blog
RSS FeedPosted by Michael Wonder on 04 Apr 2025
Uplinza (inebulizumab-cdon) is now the first and only FDA approved treatment for IgG4 related disease
3 April 2025 - Uplinza shown to deliver corticosteroid-free, flare-free, complete remission for patients in the MITIGATE trial. ...
Posted by Michael Wonder on 03 Apr 2025
Novartis receives FDA accelerated approval for Vanrafia (atrasentan), the first and only selective endothelin A receptor antagonist for proteinuria reduction in primary IgA nephropathy
3 April 2025 - Phase 3 data showed Vanrafia achieved proteinuria reduction of 36.1% (P<0.0001) vs. placebo with improvements seen at ...
Posted by Michael Wonder on 01 Apr 2025
Bavarian Nordic receives US FDA approval of freeze dried smallpox and mpox vaccine
31 March 2025 - Bavarian Nordic today announced that the US FDA has approved the freeze dried formulation of Jynneos (smallpox ...
Posted by Michael Wonder on 31 Mar 2025
Imfinzi approved in the US as first and only peri-operative immunotherapy for patients with muscle-invasive bladder cancer
31 March 2025 - Based on NIAGARA Phase 3 trial results which showed a 32% reduction in the risk of ...
Posted by Michael Wonder on 31 Mar 2025
FDA expands Pluvicto’s metastatic castration-resistant prostate cancer indication
28 March 2025 - Today, the FDA expanded the indication for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals) to ...
Posted by Michael Wonder on 30 Mar 2025
FDA issues complete response letter for etripamil for PSVT
28 March 2025 - Complete response letter focused on CMC; no clinical issues relating to etripamil raised. ...
Posted by Michael Wonder on 29 Mar 2025
FDA approves durvalumab for muscle invasive bladder cancer
28 March 2025 - Today, the FDA approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neo-adjuvant treatment, followed by ...
Posted by Michael Wonder on 29 Mar 2025
FDA approves novel treatment for haemophilia A or B, with or without factor inhibitors
28 March 2025 - Medication can be given up to once every 2 months. ...
Posted by Michael Wonder on 28 Mar 2025
Fresenius receives FDA approval for their denosumab biosimilars and secures global settlement agreement
27 March 2025 - Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht) received FDA approval for all indications of the reference products: Prolia (denosumab) ...
Posted by Michael Wonder on 27 Mar 2025
Soleno Therapeutics announces US FDA approval of Vykat XR to treat hyperphagia in Prader-Willi syndrome
26 March 2025 - First approved therapy to address hyperphagia in individuals with Prader-Willi syndrome. ...
Posted by Michael Wonder on 27 Mar 2025
FDA approves cabozantinib for adults and paediatric patients 12 years of age and older with pNET and epNET
26 March 2025 - Today, the FDA approved cabozantinib (Cabometyx, Exelixis) for adult and paediatric patients 12 years of age ...
Posted by Michael Wonder on 26 Mar 2025
Theratechnologies receives FDA approval for Egrifta WR (tesamorelin F8) to treat excess visceral abdominal fat in adults with HIV and lipodystrophy
25 March 2025 - New, improved formulation set to replace Egrifta SV. ...
Posted by Michael Wonder on 26 Mar 2025
Blujepa (gepotidacin) approved by US FDA for treatment of uncomplicated urinary tract infections in female adults and paediatric patients 12 years of age and older
25 March 2025 - Blujepa is the first in a new class of oral antibiotics for uUTIs in nearly 30 ...
Posted by Michael Wonder on 23 Mar 2025
FDA approves new prostate cancer imaging agent Gozellix
21 March 2025 - Telix Pharmaceuticals today announces that the US FDA has approved its new drug application for Gozellix ...
Posted by Michael Wonder on 21 Mar 2025
Novartis receives third FDA approval for oral Fabhalta (iptacopan) – the first and only treatment approved in C3 glomerulopathy
20 March 2025 - Phase 3 study showed sustained proteinuria reduction at one year with favourable safety. ...