Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 08 Dec 2023
FDA Approves Bio-Thera Solutions' Avzivi (bevacizumab-tnjn), a biosimilar referencing Avastin
7 December 2023 - Avzivi is the second biosimilar researched, developed, and manufactured by a Chinese pharmaceutical company to receive FDA ...
Posted by Michael Wonder on 06 Dec 2023
Novartis receives FDA approval for Fabhalta (iptacopan), offering superior haemoglobin improvement in the absence of transfusions as the first oral monotherapy for adults with PNH
6 December 2023 - Approval based on APPLY-PNH trial in adults with PNH and anaemia despite prior anti-C5 treatment, and supported ...
Posted by Michael Wonder on 01 Dec 2023
FDA grants accelerated approval to pirtobrutinib for chronic lymphocytic leukaemia and small lymphocytic lymphoma
1 December 2023 - Today, the FDA granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly) for adults with chronic lymphocytic ...
Posted by Michael Wonder on 28 Nov 2023
Aldeyra Therapeutics receives complete response letter from the US FDA for the reproxalap new drug application for the treatment of dry eye disease
27 November 2023 - Additional trial required to demonstrate positive effect on the treatment of ocular symptoms in dry eye disease. ...
Posted by Michael Wonder on 27 Nov 2023
FDA approves nirogacestat for desmoid tumours
27 November 2023 - Today, the FDA approved nirogacestat (Ogsiveo, SpringWorks Therapeutics) for adult patients with progressing desmoid tumours who ...
Posted by Michael Wonder on 23 Nov 2023
Evive Biotech and Acrotech Biopharma announce FDA approval of Ryzneuta (efbemalenograstim alfa injection) for chemotherapy-induced neutropenia
22 November 2023 - Ryzneuta is the first non-pegylated granulocyte colony-stimulating factor approved by both the US FDA and China NMPA ...
Posted by Michael Wonder on 20 Nov 2023
US FDA approves FoundationOne CDx as a companion diagnostic for AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) to identify patients with HR positive, HER2 negative advanced breast cancer
20 November 2023 - Foundation Medicine today announced that it has received approval from the US FDA for FoundationOne CDx ...
Posted by Michael Wonder on 20 Nov 2023
Teva announces approval of a generic version of Forteo (teriparatide injection) in the US
17 November 2023 - Forteo (teriparatide injection) is indicated to treat osteoporosis among certain women and men.
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Posted by Michael Wonder on 17 Nov 2023
Pfizer and Astellas' Xtandi approved by US FDA in earlier prostate cancer treatment setting
16 November 2023 - Xtandi becomes the first and only androgen receptor signalling inhibitor approved for use with or without a ...