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RSS FeedPosted by Michael Wonder on 15 Jul 2025
Moderna receives full US FDA approval for COVID-19 vaccine, Spikevax, in children aged 6 months through 11 years at increased risk for COVID-19 disease
10 July 2025 - Spikevax is now approved for all adults aged 65 years and older, and individuals aged 6 ...
Posted by Michael Wonder on 13 Jul 2025
Ultragenyx receives complete response letter from FDA for UX111 AAV gene therapy to treat Sanfilippo syndrome type A
11 July 2025 - complete response letter cited specific chemistry, manufacturing and controls related observations that are resolvable. ...
Posted 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 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 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 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
FDA approves Gamifant (emapalumab-lzsg) as first-ever treatment for adults and children with Macrophage Activation Syndrome in Still's disease
28 June 2025 - Approval based on the pooled analysis of our pivotal EMERALD and NI-0501-06 studies, showing 54% of ...
Posted by Michael Wonder on 26 Jun 2025
FDA approves updated label for Lilly’s Amyvid (florbetapir F 18 injection) to support diagnosis of Alzheimer’s disease in patients
25 June 2025 - Eli Lilly announced that the US FDA has approved a label update for Amyvid (florbetapir F ...
Posted by Michael Wonder on 25 Jun 2025
FDA approves Benlysta (belimumab) auto-injector for children with active lupus nephritis
24 June 2025 - With this approval, paediatric patients aged five years and older with active lupus nephritis will have ...
Posted by Michael Wonder on 23 Jun 2025
FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated non-small cell lung cancer
23 June 2025 - Today, the FDA granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo) for adults with locally ...
Posted by Michael Wonder on 20 Jun 2025
Cycle Pharmaceuticals’ Harliku (nitisinone) tablets receive first FDA approval as treatment for alkaptonuria
19 June 2025 - Cycle Pharmaceuticals announced that the FDA has approved Harliku (nitisinone) tablets for the reduction of urine homogentisic ...