JW Therapeutics Announces Receipt of Breakthrough Therapy …
1 day ago · The Breakthrough Therapy Designation was supported by the results from the clinical study aimed to assess the efficacy and safety of Carteyva ® in Chinese adults with r/r LBCL who were not ...
Rezolute Receives Breakthrough Therapy Designation from FDA …
3 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 ...
CDER Brings Many Safe and Effective Therapies to Patients in 2024
3 days ago · Expedited Programs: In 2024, CDER approved 33 of the 50 new therapies (66%) using one or more expedited approval programs: fast track designation, breakthrough therapy designation, priority review ...
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 ...
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 …
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...
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.
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 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.
Denali Therapeutics Announces U.S. FDA Breakthrough Therapy …
3 days ago · Breakthrough Therapy Designation is intended to expedite the development and review of therapeutic candidates that are under investigation for the treatment of serious or life-threatening conditions.