MAESTrO: Blog

Posted by Michael Wonder on 24 Oct 2025

FDA grants priority review for Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Padcev (enfortumab vedotin-ejfv), for certain patients with muscle-invasive bladder cancer

23 October 2025 - Applications based on Phase 3 KEYNOTE-905 results showing the combination improved event-free survival by 60%, reduced the ...

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Posted by Michael Wonder on 23 Oct 2025

Heidelberg Pharma’s lead ADC candidate HDP-101 granted fast track designation by US FDA for the treatment of multiple myeloma

23 October 2025 - Heidelberg Pharma today announced that HDP-101 (pamlectabart tismanitin), the Company’s lead amanitin-based ADC candidate, has been ...

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Posted by Michael Wonder on 23 Oct 2025

Zenocutuzumab-zbco granted FDA breakthrough therapy designation for NRG1 positive cholangiocarcinoma

23 October 2025 - Partner Therapeutics today announced that the US FDA has granted breakthrough therapy designation to zenocutuzumab-zbco for the ...

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Posted by Michael Wonder on 23 Oct 2025

FDA grants fast track designation for AJ201, a first in class therapy for Kennedy's disease

23 October 2025 - AnnJi Pharmaceutical today announced that the US FDA has granted fast track designation for AJ201, the first ...

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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 ...

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Posted by Michael Wonder on 23 Oct 2025

Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) sBLA granted FDA priority review for treatment of certain patients with muscle-invasive bladder cancer

21 October 2025 - Results from the pivotal EV-303 trial demonstrated that, when used before and after surgery, the combination reduced ...

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Posted by Michael Wonder on 23 Oct 2025

Electra Therapeutics receives FDA breakthrough therapy and EMA priority medicines designations for ELA026 in secondary haemophagocytic lymphohistiocytosis

22 October 2025 - Electra Therapeutics today announced that ELA026 has received US FDA breakthrough therapy designation and EMA Priority ...

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Posted by Michael Wonder on 22 Oct 2025

Myosin Therapeutics receives FDA fast track designation for MT-125 in glioblastoma

22 October 2025 - Myosin Therapeutics today announced that the US FDA has granted fast track designation to MT-125 for the ...

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Posted by Michael Wonder on 22 Oct 2025

Sanofi’s Tzield accepted for expedited review in the US for stage 3 type 1 diabetes through FDA Commissioner's National Priority Voucher pilot program

20 October 2025 - The US FDA has accepted for expedited review the supplemental biologics license application for Tzield (teplizumab-mzwv) to ...

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Posted by Michael Wonder on 22 Oct 2025

GondolaBio receives US FDA orphan drug and fast track designations for PORT-77 for the treatment of erythropoietic protoporphyria and X-linked protoporphyria

21 October 2025 - PORT-77 is currently being investigated in the Phase 2A proof of concept trial, GATEWAY, with the primary ...

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Posted by Michael Wonder on 22 Oct 2025

Immusoft receives FDA fast track designation for ISP-001, a first in class engineered B-cell therapy for MPS I

21 October 2025 - Prospectively designed for scalability and re-dosability, Immusoft's engineered B cells represent the next generation of advanced ...

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