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RSS FeedPosted by Michael Wonder on 28 Oct 2025
Cellectar Biosciences receives rare paediatric disease designation from US FDA for iopofosine I 131 in relapsed or refractory paediatric high-grade glioma
27 October 2025 - Cellectar Biosciences today announced the US FDA has granted rare paediatric drug designation for iopofosine I ...
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 27 Oct 2025
Flaws in the FDA’s new priority voucher program
25 October 2025 - A new FDA program is being promoted as a tool to facilitate the development and approval of ...
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 25 Oct 2025
Revolution Medicines awarded voucher for daraxonrasib (RMC-6236) under FDA Commissioner's National Priority Voucher Pilot Program
16 October 2025 - Revolution Medicines today announced that the US FDA has granted a non-transferrable voucher for daraxonrasib (RMC-6236), ...
Posted by Michael Wonder on 25 Oct 2025
Agitated Solutions receives fast track designation for investigational drug ASI-02
23 October 2025 - ASI-02 is a novel contrast agent for cardiac bubble studies. ...
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 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 ...
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 ...
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 ...
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 ...
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 ...