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RSS FeedPosted by Michael Wonder on 21 Dec 2023
Calliditas Therapeutics announces full FDA approval of Tarpeyo, the only FDA approved treatment for IgA nephropathy to significantly reduce the loss of kidney function
20 December 2023 - Calliditas Therapeutics today announced that the US FDA has approved Tarpeyo (budesonide) delayed release capsules to reduce ...
Posted by Michael Wonder on 21 Dec 2023
Merck provides US regulatory update on gefapixant
21 December 2023 - Merck today announced that the US FDA has issued a complete response letter regarding Merck’s new drug ...
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 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
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 17 Dec 2023
FDA approves Arcutis’ Zoryve (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in individuals aged 9 years and older
15 December 2023 - Commercial product expected to be available by end of January. ...
Posted by Michael Wonder on 15 Dec 2023
FDA approves enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial cancer
15 December 2023 - Today, the FDA approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma) in combination with pembrolizumab (Keytruda, Merck) for ...
Posted by Michael Wonder on 15 Dec 2023
FDA approves belzutifan for advanced renal cell carcinoma
14 December 2023 - Today, the FDA approved belzutifan (Welireg, Merck) for patients with advanced renal cell carcinoma following a ...
Posted by Michael Wonder on 14 Dec 2023
US FDA updates LDL-C lowering indication for Esperion’s Nexletol (bempedoic acid) tablet and Nexlizet (bempedoic acid and ezetimibe) tablet
13 December 2023 - Updated label adds primary hyperlipidaemia, removes maximally tolerated statin requirement, removes limitation of use. ...
Posted by Michael Wonder on 14 Dec 2023
Glaukos announces FDA approval of iDose TR (travoprost intracameral implant)
14 December 2023 - FDA approval based on robust Phase 3 clinical program consisting of two pivotal studies that randomised 1,150 ...
Posted by Michael Wonder on 14 Dec 2023
FDA approves eflornithine for adult and paediatric patients with high-risk neuroblastoma
13 December 2023 - Today, the FDA approved eflornithine (Iwilfin) to reduce the risk of relapse in adult and paediatric ...
Posted by Michael Wonder on 08 Dec 2023
FDA approves expanded use of Cresemba (isavuconazonium sulphate) in children with invasive Aspergillosis and invasive Mucormycosis
8 December 2023 - Approval based on results of two paediatric studies in children aged 1 to 17. ...
Posted by Michael Wonder on 08 Dec 2023
FDA approves first gene therapies to treat patients with sickle cell disease
8 December 2023 - Today, the US FDA approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies ...