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RSS FeedPosted by Michael Wonder on 15 Jul 2025
Biocon Biologics expands diabetes portfolio with FDA approval of Kirsty, the first and only interchangeable rapid acting insulin aspart in the US
15 July 2025 - Biocon Biologics today announced that the US FDA has approved Kirsty (insulin aspart-xjhz), 100 units/mL as the ...
Posted by Michael Wonder on 15 Jul 2025
Regulatory and clinical outcomes of non-oncology accelerated approvals
14 July 2025 - The US FDA accelerated approval pathway expedites drug approvals based on changes to surrogate or intermediate measures ...
Posted by Michael Wonder on 15 Jul 2025
US FDA accepts application to review expanded use of GSK’s RSV vaccine, Arexvy, for adults 18-49 at increased risk
14 July 2025 - FDA decision anticipated H1, 2026 ...
Posted by Michael Wonder on 15 Jul 2025
Atara Biotherapeutics provides regulatory and business updates on tabelecleucel
14 July 2025 - Atara Biotherapeutics resubmits tabelecleucel biologics license application for treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease to ...
Posted by Michael Wonder on 15 Jul 2025
US FDA approves finerenone for new indication in patients with heart failure with left ventricular ejection fraction of ≥40%
14 July 2025 - New indication approval follows the US FDA’s priority review designation and is based on positive results from ...
Posted 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
Milestone Pharmaceuticals announces FDA acceptance of the company’s response to the CRL for Cardamyst (etripamil) nasal spray
11 July 2025 - New PDUFA action date of 13 December 2025. ...
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. ...