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RSS FeedPosted by Michael Wonder on 13 May 2026
Kyverna Therapeutics announces initiation of rolling SPS BLA submission
12 May 2026 - The Company has initiated its rolling BLA submission, seeking priority review under the program's regenerative medicine advanced ...
Posted by Michael Wonder on 13 May 2026
BridgeBio submits NDA to FDA for encaleret for individuals living with ADH1
12 May 2026 - BridgeBio Pharma today announced the submission of its new drug application to the FDA for encaleret as ...
Posted by Michael Wonder on 13 May 2026
Agios submits sNDA to FDA for US accelerated approval of mitapivat in sickle cell disease
12 May 2026 - Agios Pharmaceuticals today announced the submission of its supplemental new drug application to the US FDA for ...
Posted by Michael Wonder on 12 May 2026
Coya Therapeutics has been granted US FDA fast track designation for COYA 302 for the treatment of amyotrophic lateral sclerosis
12 May 2026 - Coya Therapeutics today announced that the US FDA has granted fast track designation for COYA 302, ...
Posted by Michael Wonder on 12 May 2026
Emiltatug ledadotin granted breakthrough therapy designation by the US FDA for adenoid cystic carcinoma
12 May 2026 - Servier today announced that the US FDA has granted breakthrough therapy designation to emiltatug ledadotin, an investigational ...
Posted by Michael Wonder on 12 May 2026
FDA advances drug repurposing to address unmet medical needs
11 May 2026 - Agency is particularly focused on new uses to treat chronic or rare diseases. ...
Posted 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 ...