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RSS FeedPosted by Michael Wonder on 11 Jul 2025
Capricor Therapeutics provides regulatory update on deramiocel BLA for Duchenne muscular systrophy
11 July 2025 - Capricor plans to resubmit its BLA to include data from the ongoing Phase 3 HOPE-3 trial in ...
Posted by Michael Wonder on 10 Jul 2025
MHRA approves elinzanetant to treat moderate to severe vasomotor symptoms (hot flushes) caused by menopause
8 July 2025 - The MHRA has today become the first regulator in the world to approve elinzanetant (Lynkuet) for the ...
Posted by Michael Wonder on 09 Jul 2025
FDA approves updated label for Lilly's Kisunla (donanemab-azbt) with new dosing in early symptomatic Alzheimer's disease
9 July 2025 - The newly recommended dosing schedule significantly lowered ARIA-E rates compared to the original dosing schedule, adding ...
Posted by Michael Wonder on 07 Jul 2025
KalVista Pharmaceuticals announces FDA Approval of Ekterly (sebetralstat), first and only oral on-demand treatment for hereditary angioedema
7 July 2025 - First new on demand hereditary angioedema treatment in over a decade, with potential to transform management of the ...
Posted by Michael Wonder on 06 Jul 2025
MHRA approves nogapendekin alfa inbakicept to treat adult patients with non-muscle invasive bladder cancer
4 July 2025 - The MHRA has today approved nogapendekin alfa inbakicept (Anktiva) for adults with BCG unresponsive non-muscle invasive bladder ...
Posted by Michael Wonder on 04 Jul 2025
Imfinzi approved in the EU as first and only peri-operative immunotherapy for muscle-invasive bladder cancer
4 July 2025 - Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk ...
Posted by Michael Wonder on 04 Jul 2025
Jazz Pharmaceuticals receives European Commission marketing authorisation for Ziihera (zanidatamab) for the treatment of advanced HER2 positive biliary tract cancer
1 July 2025 - Conditional approval based on positive results from the HERIZON-BTC-01 Phase 2b trial. ...
Posted by Michael Wonder on 03 Jul 2025
Apotex receives Health Canada approval for Aflivu, a biosimilar to Eylea, available in pre-filled syringe and vial formats
2 July 2025 - Apotex today announced that Health Canada has approved Aflivu (aflibercept), a biosimilar to Eylea, indicated for ...
Posted by Michael Wonder on 03 Jul 2025
FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
2 July 2025 - Today, the FDA granted accelerated approval to sunvozertinib (Zegfrovy, Dizal) for adult patients with locally advanced ...
Posted by Michael Wonder on 03 Jul 2025
FDA grants priority review for Winrevair (sotatercept-csrk) to update label based on results from ZENITH trial
2 July 2025 - Merck today announced that the US FDA has accepted and granted priority review for a new supplemental ...
Posted by Michael Wonder on 03 Jul 2025
FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma
2 July 2025 - Today the FDA granted accelerated approval to linvoseltamab-gcpt (Lynozyfic, Regeneron Pharmaceuticals), a bispecific B-cell maturation antigen ...
Posted by Michael Wonder on 02 Jul 2025
Adagrasib for adults with previously treated, advanced, KRAS G12C mutation positive non-small-cell lung cancer
2 July 2025 - NICE is unable to make a recommendation on the use of adagrasib (Krazati) for the second-line treatment ...
Posted by Michael Wonder on 01 Jul 2025
Unicycive Therapeutics announces receipt of complete response letter for oxylanthanum carbonate for the treatment of hyperphosphataemia in patients with chronic kidney disease on dialysis
30 June 2025 - No other concerns stated, including pre-clinical, clinical, or safety data. ...
Posted by Michael Wonder on 01 Jul 2025
Takeda announces US FDA approval of Gammagard Liquid ERC, the only ready to use liquid immunoglobulin therapy with low immunoglobulin A content
30 June 2025 - US commercialisation of Gammagard Liquid ERC projected to begin in 2026. ...
Posted by Michael Wonder on 28 Jun 2025
Eylea 8 mg with extended 6 month treatment interval approved in the EU
27 June 2025 - The European Commission has granted a label extension in the EU for Eylea 8 mg (aflibercept 8 ...