Blog
RSS FeedPosted by Michael Wonder on 12 Jul 2026
Nicox’s NCX 470 new drug application submitted in the United States by Kowa
1 July 2026 - Submission based on positive results from two Phase 3 clinical trials, Mont Blanc and Denali. ...
Posted by Michael Wonder on 12 Jul 2026
Organogenesis announces FDA acceptance of biologics license application for ReNu for the management of symptomatic knee osteoarthritis
6 July 2026 - Organogenesis today announced that the US FDA has completed their filing determination and accepted for review the ...
Posted by Michael Wonder on 12 Jul 2026
Pharvaris announces FDA acceptance of new drug application for deucrictibant IR for on-demand treatment of hereditary angioedema attacks
6 July 2026 - Pharvaris today announced that the US FDA has accepted its new drug application for deucrictibant immediate ...
Posted by Michael Wonder on 11 Jul 2026
Elevar Therapeutics receives FDA complete response letter for combination of rivoceranib and camrelizumab as a first-line treatment for unresectable or metastatic hepatocellular carcinoma
10 July 2026 - Elevar Therapeutics today announced that the US FDA issued a complete response lette regarding its new ...
Posted by Michael Wonder on 11 Jul 2026
FDA approves pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv for muscle invasive bladder cancer
10 July 2026 - Today, the FDA approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) each ...
Posted by Michael Wonder on 11 Jul 2026
FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications
10 July 2026 - On 9 July 2026, the FDA approved isatuximab-irfc (Sarclisa Escena, Sanofi-Aventis) for subcutaneous injection for multiple myeloma ...
Posted by Michael Wonder on 10 Jul 2026
FDA approves Ennumo (pegfilgrastim-pccg), Accord BioPharma's second pegfilgrastim biosimilar to Neulasta (pegfilgrastim)
9 July 2026 - ire/ -- Accord BioPharma announced today that the US FDA has approved Ennumo (pegfilgrastim-pccg), a biosimilar to ...
Posted by Michael Wonder on 09 Jul 2026
Saol Therapeutics resubmits the new drug application for SL1009 for the treatment of pyruvate dehydrogenase complex deficiency, an ultra-rare disease
7 July 2026 - Existing data supports direct path to resubmission following constructive FDA engagement. ...
Posted by Michael Wonder on 09 Jul 2026
Immunome announces US FDA acceptance of new drug application for varegacestat for the treatment of adults with desmoid tumors
8 July 2026 - Immunome today announced the US FDA has accepted its new drug application for varegacestat, an investigational, ...
Posted by Michael Wonder on 08 Jul 2026
FDA approves new treatment to reduce proteinuria in adults with primary immunoglobulin A nephropathy
7 July 2026 - The US FDA has approved Trutakna (atacicept-vymj) to reduce proteinuria in adults with primary immunoglobulin A nephropathy ...
Posted by Michael Wonder on 06 Jul 2026
Ascelia Pharma provides update on the Orviglance new drug application
3 July 2026 - Ascelia Pharma today announced that it has received a complete response letter from the US FDA regarding ...
Posted by Michael Wonder on 03 Jul 2026
FDA approves allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq for use in matched donor hematopoietic stem cell transplantation for adults with hematologic malignancies
30 June 2026 - Today, the FDA approved allogeneic regulatory T cell-based immunotherapy with hematopoietic stem and progenitor cell and ...
Posted by Michael Wonder on 02 Jul 2026
Cogent Biosciences announces submission of new drug application for bezuclastinib in advanced systemic mastocytosis
30 June 2026 - Cogent Biosciences today announced it has submitted its new drug application to the US FDA for ...
Posted by Michael Wonder on 02 Jul 2026
Galderma provides progress update regarding relabotulinumtoxinA regulatory submission in the US
1 July 2026 - Galderma today provided progress updates regarding the regulatory review of its pending biologics license application for relabotulinumtoxinA ...
Posted by Michael Wonder on 02 Jul 2026
Unicycive Therapeutics receives complete response letter from FDA regarding resubmitted oxylanthanum carbonate new drug application
30 June 2026 - Unicycive Therapeutics today announced that it has received a complete response letter from the US FDA regarding ...