- FDA Awards Breakthrough Therapy Designation to Novel HER2 ...🔍
- FDA Grants T|DXd Breakthrough Therapy Designation in HR+/ ...🔍
- FDA grants accelerated approval to fam|trastuzumab deruxtecan ...🔍
- ENHERTU® Granted Breakthrough Therapy Designation in U.S. for ...🔍
- FDA Grants Breakthrough Therapy Designation to DS|8201a and T ...🔍
- US FDA Grants Breakthrough Therapy Designation for Novel TKI ...🔍
- FDA Grants Breakthrough Therapy Designation to BNT323/DB|1303 ...🔍
- Zymeworks Receives FDA Breakthrough Therapy Designation for ...🔍
FDA Awards Breakthrough Therapy Designation to Novel HER2 ...
FDA Awards Breakthrough Therapy Designation to Novel HER2 ...
The FDA has granted a breakthrough therapy designation to BAY 2927088 for the treatment of non-small cell lung cancer harboring ...
FDA Grants T-DXd Breakthrough Therapy Designation in HR+/ ...
1. ENHERTU® granted breakthrough therapy designation in U.S. for certain patients with HER2 low or HER2 ultralow metastatic breast cancer. News ...
FDA grants accelerated approval to fam-trastuzumab deruxtecan ...
FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or ... On April 5, 2024, the Food and Drug Administration granted ...
ENHERTU® Granted Breakthrough Therapy Designation in U.S. for ...
The FDA granted this BTD based on data from the DESTINY-Breast06 phase 3 trial presented as a late-breaking oral session at the 2024 American ...
FDA Grants Breakthrough Therapy Designation to DS-8201a and T ...
The FDA has granted fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo, AstraZeneca) breakthrough therapy designation for the treatment of unresectable ...
US FDA Grants Breakthrough Therapy Designation for Novel TKI ...
US FDA Grants Breakthrough Therapy Designation for Novel TKI Targeting HER2, EGFR ... The move was supported by preliminary evidence from a phase ...
FDA Grants Breakthrough Therapy Designation to BNT323/DB-1303 ...
The FDA has granted breakthrough therapy designation to the HER2-targeted antibody-drug conjugate (ADC) BNT323/DB-1303 for use as a potential therapeutic ...
Zymeworks Receives FDA Breakthrough Therapy Designation for ...
Zymeworks Receives FDA Breakthrough Therapy Designation for HER2-Targeted Bispecific Antibody Zanidatamab in Patients with Biliary Tract Cancer.
FDA Grants Breakthrough Therapy Designation for Trastuzumab ...
Trastuzumab deruxtecan has been granted breakthrough therapy designation by the FDA for the treatment for HER2-low metastatic breast cancer.
Currently, there is no FDA-approved therapy for patients with HER2-positive metastatic breast cancer with disease progression following ...
Novel TKI Earns FDA Breakthrough Therapy Designation in HER2 ...
Preliminary findings from a phase 1 trial support the breakthrough therapy designation for BAY 2927088 as a treatment for those with ...
FDA Grants Breakthrough Therapy Designation to Trastuzumab ...
“This is an important step in bringing [trastuzumab deruxtecan] as a potential new option in earlier lines of treatment for HER2-positive ...
FDA Grants Breakthrough Therapy Designation to Inavolisib for ...
Inavolisib was submitted to the FDA for review as a first-line treatment for advanced HR-positive, HER2-negative PIK3CA-mutated breast cancer.
FDA Grants Breakthrough Therapy Designations to Trastuzumab ...
“[Trastuzumab deruxtecan] is the first HER2 directed therapy to demonstrate a potential benefit across a series of difficult-to-treat cancers ...
FDA Awards Breakthrough Therapy Designation to Novel HER2 ...
FDA Awards Breakthrough Therapy Designation to Novel HER2-Activating NSCLC Therapy · LungCancerSupport · More posts you may like.
U.S. FDA Grants Breakthrough Therapy Designation for Disitamab ...
It has a novel antibody with a higher affinity to HER2 compared to standard of care, and superior antitumor activity compared to other ...
FDA approves fam-trastuzumab deruxtecan-nxki for HER2-low ...
On August 5, 2022, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with ...
Breakthrough Therapies - Friends of Cancer Research
As of June 30, 2024, the FDA has approved 317* breakthrough therapy designated products and lists that there have been 1516 total requests for the designation ...
Breakthrough therapy designation: The real-world impact of ... - CAS
Once designated as breakthrough therapies, investigational drugs receive intensive FDA guidance on an efficient drug development program, an organizational ...
BioNTech and DualityBio Receive FDA Breakthrough Therapy ...
(“DualityBio”) today announced that the U.S. Food and Drug Administration (“FDA”) granted Breakthrough Therapy designation for BNT323/DB-1303 ...