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RSS FeedPosted by Michael Wonder on 12 May 2026
Sironax’s SARM1 inhibitor SIR2501 granted FDA fast track designation in chemotherapy-induced peripheral neuropathy
11 May 2026 - Sironax today announced that the US FDA has designated its SARM1 inhibitor SIR2501 as a fast track ...
Posted by Michael Wonder on 11 May 2026
Zai Lab receives US FDA fast track designation for zocilurtatug pelitecan (Zoci), a DLL3 targeting ADC, for treatment of extrapulmonary neuroendocrine carcinomas
11 May 2026 - Zai Lab today announced the US FDA has granted fast track designation to zocilurtatug pelitecan (zoci, formerly ...
Posted by Michael Wonder on 09 May 2026
argenx announces US FDA approval expanding Vyvgart and Vyvgart Hytrulo for use in all adult patients living with gMG
8 May 2026 - argenx today announced the US FDA approved a label expansion for Vyvgart (efgartigimod alfa-fcab) and Vyvgart Hytrulo ...
Posted by Michael Wonder on 08 May 2026
Nuvation Bio announces FDA acceptance of supplemental new drug application for Ibtrozi (taletrectinib) with updated duration of response in advanced ROS1 positive non-small-cell lung cancer
6 May 2026 - Application includes updated TRUST-I TKI naïve median duration of response and median progression-free survival of more than ...
Posted by Michael Wonder on 08 May 2026
FDA grants seventh approval under the National Priority Voucher Pilot Program
8 May 2026 - The US FDA today issued an approval for Bizengri (zenocutuzumab-zbco), a drug that treats NRG1 fusion ...
Posted by Michael Wonder on 08 May 2026
Update on FDA priority review of Leqembi Iqlik (lecanemab-irmb) subcutaneous injection as a starting dose for early Alzheimer’s disease
8 May 2026 - Eisai and Biogen today announced that the US FDA has extended the review period by three months ...
Posted by Michael Wonder on 08 May 2026
Rznomics announces US FDA regenerative medicine advanced therapy designation granted to RZ-001 for hepatocellular carcinoma
8 May 2026 - RMAT designation based on promising Phase 1b/2a clinical data, including safety profile and preliminary response rates, ...
Posted by Michael Wonder on 07 May 2026
Repertoire Immune Medicines announces FDA fast track designation for its investigational immune medicine, RPTR-1-201
7 May 2026 - Repertoire Immune Medicines today announced that the US FDA has granted fast track designation to RPTR-1-201 for ...
Posted by Michael Wonder on 07 May 2026
Armata Pharmaceuticals secures FDA fast track designation for AP-SA02
7 May 2026 - Armata Pharmaceuticals today announced that the US FDA has granted fast track designation to AP-SA02, the Company's ...
Posted by Michael Wonder on 07 May 2026
Partner Therapeutics announces receipt of FDA Commissioner's National Priority Voucher for Bizengri (zenocutuzumab-zbco) in NRG1 fusion positive cholangiocarcinoma
6 May 2026 - Partner Therapeutics today announced that the US FDA has awarded a Commissioner's National Priority Voucher pilot program ...
Posted by Michael Wonder on 07 May 2026
Diakonos Oncology awarded fast track designation by FDA for DOC1021 (dubodencel) in unresectable or metastatic cutaneous melanoma
6 May 2026 - Diakonos Oncology announced today that the US FDA has granted fast track designation to DOC1021, the ...
Posted by Michael Wonder on 06 May 2026
ICER publishes protocol for annual launch price and access report
4 May 2026 - The ICER posted a protocol today outlining how it will conduct its second annual analysis titled the ...
Posted by Michael Wonder on 06 May 2026
Guardant Health receives FDA approval for Guardant360 CDx as a companion diagnostic for Arvinas and Pfizer’s Veppanu (vepdegestrant) for patients with ER+/HER2- advanced breast cancer with ESR1 mutations
4 May 2026 - Guardant Health today announced that the US FDA has approved the Guardant360 CDx liquid biopsy test ...
Posted by Michael Wonder on 05 May 2026
FDA grants fast track designation for CS-1103, a first in class small molecule to reverse acute intoxication from fentanyl
5 May 2026 - Clear Scientific announced today that the US FDA has granted its lead asset, CS-1103, fast track designation ...
Posted by Michael Wonder on 05 May 2026
Spinogenix receives US FDA fast track designation for tazbentetol for the treatment of ALS
5 May 2026 - Spinogenix today announced that the US FDA has granted fast track designation to tazbentetol for the ...