Why Some Food Additives Banned in Europe Are Still on U.S. Shelves
The unusual way the U.S. regulates ingredients is in the news and the hot seat right now, thanks to the recent ban of a food ...
FiercePharma2d
Pfizer's Braftovi combo on track for full approval in win for FDA's Project FrontRunner
Less than two months after an accelerated approval from the FDA, a drug combination featuring Pfizer’s Braftovi has turned in ...
The American Journal of Managed Care5d
FDA Approves First HER2-Ultralow Companion Diagnostic, Expanding Treatment Eligibility
Roche’s PATHWAY HER2 (4B5) test helps identify patients with HER2-ultralow breast cancer, who may be eligible for targeted ...
360dx5d
FDA Approves Roche Antibody Test as CDx for Enhertu in HER2-Ultralow Breast Cancer Patients
The tissue-based test is approved to identify a new classification in HER2 expression designated as HER2-ultralow.
Roche Gets FDA Approval for Breast Cancer Test
The Swiss pharmaceutical company said the FDA backed a label expansion for the Pathway HER2 (4B5) test to identify patients with HR-positive, HER2-ultralow metastatic breast cancer who could be ...
FDA approves Datroway for HR-positive, HER2-negative breast cancer
The U.S. Food and Drug Administration has approved Datroway (datopotamab deruxtecan-dlnk) for adult patients with ...
Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU
As seen in the DESTINY-Breast06 trial, approximately 20-25 percent of hormone receptor (HR)-positive, HER2-negative breast cancer patients may be considered HER2-ultralow.1 These patients may now be ...
JD Supra6d
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...
BioPharma Dive7d
Enhertu, with new OK, set to supplant chemo in HER2-low breast cancer
The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety ...
FDA expands Enhertu approval to include HER2-ultralow breast cancer patients
AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has received approval from ...
precisionmedicineonline8d
FDA Approves AstraZeneca, Daiichi Sankyo's Enhertu in HER2-Ultralow Breast Cancer
The agency approved the drug based on data from the DESTINY-Breast06 trial, which included patients who had tumors with very low HER2 expression.
Could the FDA's recently approved Pap smear alternative reduce racial disparities in cervical cancer deaths?
Northwell Health partnered with Stacker to explore how a new Pap smear alternative may help prevent deaths from cervical ...