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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
Arialys Therapeutics announces US FDA fast track designation for ART5803, the first precision therapeutic candidate in development for the treatment of anti-NMDA receptor encephalitis
9 July 2026 - Arialys Therapeutics today announced that the US FDA has granted fast track designation to ART5803 for ...
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
Terremoto Biosciences granted FDA fast track designation for TER-2013, an AKT1 selective small molecule inhibitor for breast cancer
3 July 2026 - Terremoto Biosciences today announced that the US FDA granted fast track designation for TER-2013, the Company’s lead ...
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
Merck announces FDA breakthrough therapy designation for enpatoran in lupus patients with active skin manifestations
8 July 2026 - Merck today announced that the US FDA has granted breakthrough therapy designation to enpatoran for the ...
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 08 Jul 2026
US FDA grants priority review to Agios’ sNDA for mitapivat in sickle cell disease
7 July 2026 - Agios Pharmaceuticals today announced that the US FDA has accepted its supplemental new drug application for mitapivat, ...
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 ...