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RSS FeedPosted 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
Chronic kidney treatment made cheaper for people like Franki
28 October 2025 - A diabetes drug that helps to slow kidney damage will be made available to more people ...
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 27 Oct 2025
Long-lasting contraceptive gets new PBS listing
26 October 2025 - Women will be given more birth control choices from Saturday with a monthly vaginal ring, which can ...
Posted by Michael Wonder on 27 Oct 2025
Delivering better access to contraception for Australian women
27 October 2025 - Australian women will soon have better access to affordable contraceptive options thanks to the Australian Government’s ...
Posted by Michael Wonder on 27 Oct 2025
Health Canada grants authorisation for Leqembi (lecanemab) for the treatment of early Alzheimer’s disease
26 October 2025 - Eisai and Biogen announced today that Health Canada has issued a notice of compliance with conditions for ...
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 24 Oct 2025
Up to 6,000 patients to benefit from NICE-approved life-extending prostate cancer drug
24 October 2025 - People living with metastatic prostate cancer in England will gain access to a new treatment combination from ...
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 24 Oct 2025
Biocon Biologics receives Health Canada spproval for Yesintek and Yesintek I.V. (ustekinumab), a biosimilar to Stelara
23 October 2025 - Biocon Biologics today announced that Health Canada has granted a notice of compliance for Yesintek (ustekinumab ...