CAR T therapies have transformed treatment options for some blood cancers. They have also exposed one of cell therapy's ...
Imugene Ltd (ASX:IMU, OTC:IUGNF, FRA:ILA) earlier this week announced that the US Food and Drug Administration (FDA) granted ...
FDA fast-tracks VS-7375, an oral KRAS G12D inhibitor, opening new hope for pretreated advanced NSCLC and fueling pivotal ...
FDA cleared the Harmony-HHT Phase 1/2 study design, enabling Atavistik Bio to leverage existing clinical data with ATV-1601 and advance directly ...
MTX-001 is an investigational biologic therapy being developed to address underlying biological deficiencies associated with impaired wound healing. The therapy is designed to deliver a concentrated ...
FDA fast track designation supports development of pelareorep plus bevacizumab/FOLFIRI in 2L KRAS-mutant MSS mCRC, enabling more frequent regulatory engagement and potential accelerated pathways.
The Dermatology Division of the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sonelokimab (SLK) in moderate-to-severe palmoplantar pustulosis (PPP) supported by ...
NASHVILLE, Tenn., Feb. 4, 2026 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company focused on developing new products for rare diseases, announced today ...
FDA Fast Track Designation granted to 4P004 for the treatment of knee osteoarthritis, recognizing the disease as a serious condition with significant unmet medical need Designation supports enhanced ...
Fast Track status aims to accelerate development of an autologous dendritic cell immunotherapy for advanced cutaneous melanoma with limited durable benefit from current standards in many patients.
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