U.S. FDA Grants Breakthrough Therapy Designation to Trodelvy ...
2 天之前 · Breakthrough Therapy Designation is designed to expedite the development and regulatory review of investigational treatments for serious or life-threatening conditions that, based on preliminary clinical evidence, have the potential to substantially improve clinical outcomes compared with available therapy. This is the second Breakthrough ...
FDA grants tolebrutinib breakthrough therapy designation in SPMS
1 天前 · 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 ...
FDA Grants Breakthrough Therapy Designation to Tolebrutinib …
2 天之前 · The condition is experienced as symptoms including fatigue, cognitive impairment, gait and balance issues, sexual dysfunction, and loss of bowel and/or bladder function, among others, according to the news release. 1 “This breakthrough therapy designation demonstrates the potential for tolebrutinib to delay disability progression, a critical ...
Press Release: Tolebrutinib designated Breakthrough Therapy by …
6 天之前 · Tolebrutinib designated Breakthrough Therapy by the FDA for non-relapsing secondary progressive multiple sclerosis Designation is based on positive results from the HERCULES study in adults with ...
FDA Grants Breakthrough Therapy Designation to Seres …
2024年12月9日 · FDA Breakthrough Therapy designation ensures communication and guidance from FDA to expedite the development of medicines which are intended to treat serious or life-threatening...
2024年12月9日 · “This Breakthrough Therapy Designation reinforces datopotamab deruxtecan as a promising potential therapy for patients with EGFR-mutated lung cancer who continue to face significant unmet needs following disease progression on or after initial treatments,” said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology R&D, AstraZeneca.
Trial of cell-based therapy for high-risk lymphoma leads to FDA ...
2024年7月9日 · 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.
Tobevibart Plus Elebsiran Designated Breakthrough Therapy for …
18 小时之前 · The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta (CHD) in adults.. The Breakthrough Therapy designation is supported by data from the randomized, open-label phase 2 SOLSTICE trial (ClinicalTrials.gov Identifier: NCT05461170), which evaluated the efficacy and safety of ...
FDA Grants Breakthrough Therapy Designation to Sacituzumab …
1 天前 · U.S. FDA grants breakthrough therapy designation to Trodelvy® (sacituzumab govitecan-hziy) for second-line treatment of extensive-stage small cell lung cancer. News Release. Gilead. December 17 ...
FDA Grants Breakthrough Therapy Status To Gilead's Trodelvy …
1 天前 · (RTTNews) - Gilead Sciences, Inc. (GILD) Tuesday said that the U.S. Food and Drug Administration or FDA has granted Breakthrough Therapy Designation to Trodelvy for the treatment of adults with ...