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RSS FeedPosted by Michael Wonder on 06 Nov 2025
FDA approves daratumumab and hyaluronidase-fihj for high-risk smoldering multiple myeloma
6 November 2025 - On November 6, 2025, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech) ...
Posted by Michael Wonder on 05 Nov 2025
FDA issues complete response letter for Biohaven's Vyglyxia (troriluzole) new drug application for spinocerebellar ataxia
4 November 2025 - Biohaven today announced that it has received a complete response letter from the US FDA for the ...
Posted by Michael Wonder on 04 Nov 2025
US FDA grants interchangeability designation to Celltrion's denosumab biosimilars, Stoboclo (denosumab-bmwo) and Ozenvelt (denosumab-bmwo)
30 October 2025 - The US FDA approved Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo) as interchangeable with the reference products Prolia (denosumab) ...
Posted by Michael Wonder on 03 Nov 2025
US FDA approves Kygevvi (doxecitine and doxribtimine), the first and only treatment for adults and children living with thymidine kinase 2 deficiency
3 November 2025 - UCB today announced that Kygevvi has been granted approval by the US FDA for the treatment ...
Posted by Michael Wonder on 03 Nov 2025
Alvotech provides update on the status of US biologics license application for AVT05
2 November 2025 - Alvotech announced today that the US FDA has issued a complete response letter for Alvotech’s biologics ...
Posted by Michael Wonder on 27 Oct 2025
US FDA approves updated indication for Winrevair (sotatercept-csrk) in adults with pulmonary arterial hypertension (WHO Group 1 pulmonary hypertension) based on Phase 3 ZENITH study
27 October 2025 - Merck today announced that the US FDA has approved an update to the US product label based ...
Posted by Michael Wonder on 27 Oct 2025
Lilly's Omvoh (mirikizumab-mrkz) approved by US FDA as a single-injection maintenance regimen in adults with ulcerative colitis
27 October 2025 - Omvoh now offers patients a simplified maintenance experience with one monthly injection, replacing the previous two injection ...
Posted by Michael Wonder on 25 Oct 2025
Receipt of complete response ketter from US FDA for investigational ND0612
23 October 2025 - Mitsubishi Tanabe Pharma today announced that the US FDA has issued a complete response letter for ...
Posted by Michael Wonder on 24 Oct 2025
Bayer’s Lynkuet (elinzanetant) approved in the US for treatment of moderate to severe vasomotor symptoms due to menopause
24 October 2025 - This approval is supported by data from the Phase 3 OASIS clinical program evaluating Lynkuet (elinzanetant) for ...
Posted by Michael Wonder on 24 Oct 2025
FDA approves revumenib for relapsed or refractory acute myeloid leukaemia with a susceptible NPM1 mutation
24 October 2025 - Today, the FDA approved revumenib (Revuforj, Syndax Pharmaceuticals), a menin inhibitor, for relapsed or refractory acute ...
Posted by Michael Wonder on 24 Oct 2025
Sydnexis receives complete response letter from FDA for SYD-101 to slow paediatric myopia progression
23 October 2025 - Sydnexis, today announced that the US FDA has issued a complete response letter for the new ...
Posted by Michael Wonder on 23 Oct 2025
FDA approves belantamab mafodotin-blmf for relapsed or refractory multiple myeloma
23 October 2025 - Today, the FDA approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline), a B-cell maturation antigen (BCMA)-directed antibody and microtubule ...
Posted by Michael Wonder on 21 Oct 2025
Glaukos announces FDA approval of Epioxa
20 October 2025 - Epioxa expected to be commercially available in Q1, 2026. ...
Posted by Michael Wonder on 20 Oct 2025
FDA approves Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
20 October 2025 - FDA approval based on superiority of Gazyva/Gazyvaro over standard therapy alone, as shown in Phase 2 NOBILITY ...
Posted by Michael Wonder on 20 Oct 2025
Xbrane provides regulatory update on FDA review of its ranibizumab biosimilar candidate
19 October 2025 - Xbrane Biopharma announce that the US FDA has issued a complete response letter to the Company’s biologics ...