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RSS FeedPosted by Michael Wonder on 23 Jan 2025
Stealth BioTherapeutics announces PDUFA action date extension for elamipretide to treat patients with Barth syndrome
23 January 2025 - New PDUFA action date of 29 April 2025, allows FDA additional time to complete review. ...
Posted by Michael Wonder on 23 Jan 2025
Scilex announces that the US FDA has acknowledged the submission of our supplemental new drug application for Elyxyb in acute pain indication
22 January 2025 - Scilex today announced that the US FDA has acknowledged the submission of our supplemental new drug application ...
Posted by Michael Wonder on 23 Jan 2025
Medexus announces FDA approval of Grapafex (treosulphan) for injection
22 January 2025 - Medexus will target a commercial launch in 1H CY2025; potential for annual product-level revenue to exceed ...
Posted by Michael Wonder on 22 Jan 2025
Bluejay Therapeutics receives US FDA breakthrough therapy designation for brelovitug (BJT-778) for the treatment of chronic hepatitis delta
21 January 2025 - Bluejay Therapeutics today announced that its lead product candidate brelovitug (also known as BJT-778) has received ...
Posted by Michael Wonder on 22 Jan 2025
Nacuity Pharmaceuticals granted US FDA fast track designation for NPI-001 (N-acetylcysteine amide) tablets for the treatment of retinitis pigmentosa
21 January 2025 - Nacuity Pharmaceuticals today announced that the US FDA has granted fast track designation to NPI-001 (N-acetylcysteine amide) ...
Posted by Michael Wonder on 21 Jan 2025
Spravato (esketamine) approved in the US as the first and only monotherapy for adults with treatment-resistant depression
21 January 2024 - Following US FDA priority review, approval is based on data demonstrating Spravato alone met its primary endpoint ...
Posted by Michael Wonder on 17 Jan 2025
FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR positive, HER2 negative breast cancer
17 January 2025 - Today, the FDA approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo), a Trop-2-directed antibody and topoisomerase inhibitor conjugate, ...
Posted by Michael Wonder on 17 Jan 2025
Innovent receives NMPA breakthrough therapy designation for IBI343 (anti-CLDN18.2 ADC) as monotherapy for advanced pancreatic cancer
16 January 2025 - Innovent Biologics announced that the Center for Drug Evaluation of China's National Medical Products Administration has granted ...
Posted by Michael Wonder on 16 Jan 2025
FDA approves sotorasib with panitumumab for KRAS G12C mutated colorectal cancer
16 January 2025 - Today, the FDA approved sotorasib (Lumakras, Amgen) with panitumumab (Vectibix, Amgen) for adult patients with KRAS ...
Posted by Michael Wonder on 16 Jan 2025
Foresee Pharmaceuticals announces the PDUFA goal date for the 3 month version of Camcevi is 29 August 2025
13 January 2025 - Foresee Pharmaceuticals announces that the US FDA issued a Day 74 letter. ...
Posted by Michael Wonder on 16 Jan 2025
FDA approves acalabrutinib with bendamustine and rituximab for previously untreated mantle cell lymphoma
16 January 2025 - Today, the FDA granted traditional approval to acalabrutinib (Calquence, AstraZeneca) with bendamustine and rituximab for adults ...
Posted by Michael Wonder on 16 Jan 2025
Incyte and Syndax announce US FDA approval of Niktimvo (axatilimab-csfr) 9 mg & 22 mg vial sizes
15 January 2025 - US launch expected in early February. ...
Posted by Michael Wonder on 15 Jan 2025
New drug application initiated with US FDA for TAR-200, the first and only intravesical drug releasing system for patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer
15 January 2025 - Application accepted for US FDA Real-Time Oncology Review based on Phase 2b SunRISe-1 study showing highest ...
Posted by Michael Wonder on 15 Jan 2025
FDA approves Lilly's Omvoh (mirikizumab-mrkz) for Crohn's disease, expanding its use to the second major type of inflammatory bowel disease
15 January 2025 - In the pivotal Phase 3 VIVID-1 trial, patients treated with Omvoh experienced significant improvement in clinical ...
Posted by Michael Wonder on 14 Jan 2025
Lokon Pharma receives FDA fast track designation for LOAd703 for the treatment of pancreatic cancer
10 January 2025 - Lokon Pharma today announced that the US FDA has granted fast track designation for the company´s product ...