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RSS FeedPosted by Michael Wonder on 14 Apr 2026
Travere Therapeutics announces full FDA approval of Filspari (sparsentan), the first and only approved medicine for FSGS
13 April 2026 - Travere Therapeutics today announced that the US FDA has approved Filspari (sparsentan) to reduce proteinuria in adult ...
Posted by Michael Wonder on 11 Apr 2026
FDA approves updated Vabysmo label to extend treatment for macular oedema following retinal vein occlusion beyond six months
9 April 2026 - Genentech has received US FDA approval of Vabysmo (faricimab-svoa) for the treatment of macular oedema due to ...
Posted by Michael Wonder on 10 Apr 2026
Replimune receives complete response letter from the FDA for RP1 biologics license application for the treatment of advanced melanoma
10 April 2026 - Replimune Group today announced that the company received a complete response letter from the US FDA ...
Posted by Michael Wonder on 10 Apr 2026
Foundayo (orforglipron), Lilly's new oral GLP-1 pill for weight loss, now available in the US
9 April 2026 - Foundayo, the only GLP-1 pill for weight loss that can be taken any time of day ...
Posted by Michael Wonder on 07 Apr 2026
FDA approves first generic dapagliflozin tablets
7 April 2026 - FDA approves multiple generics of Farxiga. ...
Posted by Michael Wonder on 02 Apr 2026
Eylea HD (aflibercept) approved by FDA as first and only injectable anti-VEGF with dosing intervals up to 5 months for wet age-related macular degeneration and diabetic macular oedema
2 April 2026 - Regeneron Pharmaceuticals today announced that the US FDA has approved the extension of dosing intervals for Eylea ...
Posted by Michael Wonder on 01 Apr 2026
FDA approves Lilly's Foundayo (orforglipron), the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions
1 April 2026 - Foundayo, Lilly's second FDA approved obesity medicine, will be available via LillyDirect with free home delivery, ...
Posted by Michael Wonder on 01 Apr 2026
Vertex announces US FDA approval for label extensions of Alyftrek and Trikafta, expanding availability of these medicines to ~95% of all people with CF in the United States
1 April 2026 - Vertex Pharmaceuticals today announced the US FDA has approved expanded use of Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) for the ...
Posted by Michael Wonder on 01 Apr 2026
FDA approves first new molecular entity under National Priority Voucher Program
1 April 2026 - The US FDA today approved Foundayo (orforglipron), marking the fifth approval under the Commissioner's National Priority Voucher ...
Posted by Michael Wonder on 31 Mar 2026
Teva gains biosimilar momentum with US FDA approval of Ponlimsi (denosumab-adet) and dual filing acceptance for biosimilar candidate to Xolair (omalizumab)
30 March 2026 - Teva Pharmaceutical Industries today announced three milestones in its biosimilar portfolio, demonstrating continued momentum in the ...
Posted by Michael Wonder on 27 Mar 2026
Awiqli approved in the US, the first and only once weekly basal insulin treatment for adults with type 2 diabetes
27 March 2026 - Novo Nordisk expects to launch Awiqli nationwide in the US in the second half of 2026. ...
Posted by Michael Wonder on 27 Mar 2026
FDA approves first gene therapy for severe leukocyte adhesion deficiency type I
26 March 2026 - The US FDA today approved Kresladi (marnetegragene autotemcel), the first gene therapy for the treatment of severe ...
Posted by Michael Wonder on 25 Mar 2026
FDA approves drug to treat neurologic manifestations of Hunter syndrome
25 March 2026 - The US FDA approved Avlayah (tividenofusp alfa-eknm) to treat certain individuals with Hunter syndrome (mucopolysaccharidosis type II ...
Posted by Michael Wonder on 25 Mar 2026
FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer
25 March 2026 - Today, the FDA approved relacorilant (Lifyorli, Corcept Therapeutics), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel ...
Posted by Michael Wonder on 20 Mar 2026
Bristol Myers Squibb transforms the classical Hodgkin lymphoma treatment paradigm with expanded US and EMA approvals for Opdivo (nivolumab)
20 March 2026 - Bristol Myers Squibb today announced that Opdivo (nivolumab) has received approval for two new classical Hodgkin ...