Rezolute Receives Breakthrough Therapy Designation from FDA …
2 days ago · Breakthrough Therapy Designation for ersodetug is designed to expedite the development and regulatory review of investigational treatments for serious or life-threatening conditions that, based on ...
Press Release: Tolebrutinib designated Breakthrough Therapy by …
Tolebrutinib is the first and only brain-penetrant BTK inhibitor in MS to be designated Breakthrough Therapy by the FDA Paris, December 13, 2024. The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tolebrutinib for the treatment of adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS).
Cell & Gene Therapies in 2025: Breakthroughs, Challenges, and the …
3 days ago · Breakthrough Approvals in 2024. 2024, ushered in by the FDA approval of the first treatments using the Nobel Prize-winning CRISPR gene-editing system, got off to a ground-breaking start for cell and gene therapy. ... CEO and president of Vertex called “a one-time transformative therapy.” Other breakthrough approvals in 2024 came in the form ...
FDA Grants Breakthrough Therapy Designation to Trodelvy for …
Dec 23, 2024 · Trodelvy received Breakthrough Therapy designation for ES-SCLC after platinum-based chemotherapy, aiming to expedite its development and review. The phase 2 TROPiCS-03 study showed a 41.9% overall response rate for Trodelvy in ES-SCLC, with all responses being partial. Trodelvy targets TROP2, a cell ...
FDA grants tolebrutinib breakthrough therapy designation in SPMS
Dec 17, 2024 · The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Sanofi’s BTK inhibitor candidate tolebrutinib for the treatment of adults with nonrelapsing secondary...
U.S. FDA Grants Breakthrough Therapy Designation to Trodelvy ...
Dec 17, 2024 · FOSTER CITY, Calif.-- (BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Trodelvy ® (sacituzumab govitecan-hziy) for the treatment of adult patients with extensive-stage small cell lung …
Breakthrough Therapy Obliterates Deadly Brain Tumor in Days
Mar 15, 2024 · Brain scans of a 72-year-old man diagnosed with a highly aggressive form of cancer known as a glioblastoma have revealed a remarkable regression in his tumor's size within days of receiving an infusion of an innovative new treatment.
FDA Grants Breakthrough Therapy Designation to Sacituzumab …
Dec 3, 2024 · The FDA’s Breakthrough Therapy designation is granted to expedite the development and review of medicines that are intended to treat serious or life-threatening conditions.
Trial of cell-based therapy for high-risk lymphoma leads to FDA ...
Jul 9, 2024 · In September 2022, the FDA designated CD22-targeting CAR-T therapy for large B-cell lymphoma a Breakthrough Therapy, a move that is meant to speed the development and review of particularly promising drugs that may provide a substantial improvement over existing therapies for serious conditions.
FDA Grants Breakthrough Therapy Designation to Sac-TMT for …
Dec 5, 2024 · Sacituzumab tirumotecan targets TROP2 and is being developed for EGFR-mutated NSCLC after TKI and chemotherapy failure. The FDA's breakthrough therapy designation is based on phase 2 data, highlighting sac-TMT's potential in NSCLC treatment.