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precisionmedicineonline
3 天
At Some Hospitals, Expert Panels Help Guide Anti-Amyloid Drug Decisions for Alzheimer's ...
These boards are cropping up around the US as neurologists acclimate to a new class of drugs, but not everyone agrees such ...
precisionmedicineonline
2 天
NICE Recommends Vertex, CRISPR Therapeutics' Casgevy for Sickle Cell Under Managed Access Deal
The gene-editing treatment will be available to certain patients with sickle cell disease in England as Vertex commits to collecting additional data.
precisionmedicineonline
1 天
CHMP Recommends European Approval for AstraZeneca, Daiichi Sankyo's Datroway in Breast Cancer
The committee's recommendation was based on data from the TROPION-Breast01 trial, which also supported the US approval of Datroway in January.
precisionmedicineonline
5 天
FDA Issues Safety Alert Reminding Doctors to Discuss DPD Deficiency Risk With Cancer Patients
The FDA, which has stopped short of requiring DPYD testing for patients before receiving fluoropyrimidines, emphasized the ...
precisionmedicineonline
1 天
CHMP Issues Positive Opinion for BMS's Breyanzi in Third-Line Follicular Lymphoma
The committee reviewed data showing a 94 percent complete response rate as a third- or later-line treatment for refractory follicular lymphoma.
precisionmedicineonline
2 天
AstraZeneca, Daiichi Sankyo Begin Phase III Trial of Datroway in High-Risk Early-Stage NSCLC
The firms will evaluate two adjuvant treatment options, Datroway with rilvegostomig or rilvegostomig monotherapy, against standard-of-care treatment.
precisionmedicineonline
2 天
Fractyl Health Expects to Launch Clinical Trial of Type 2 Diabetes Gene Therapy in 2025
While the company is prioritizing RJVA-001 and a lead program in obesity, it's pausing some R&D efforts and laying off 17 percent of its workforce.
precisionmedicineonline
1 天
Novartis Posts Strong Q4 Sales of Kisqali, Pluvicto
During 2024, the radiopharmaceutical Pluvicto achieved blockbuster status, while sales of the breast cancer drug Kisqali grew 46 percent compared to 2023.
precisionmedicineonline
5 天
Sarepta's DMD Gene Therapy Elevidys Shows Sustained Benefits in Updated Phase III Data
The positive results from the second part of the EMBARK trial contrast with findings from one-year post treatment, which did ...
precisionmedicineonline
3 天
EC Approves Amgen's Blincyto as Consolidation Treatment for Certain Newly Diagnosed ...
The EC's decision was based on results from a Phase III trial of Blincyto with multiphase consolidation chemotherapy.
precisionmedicineonline
3 天
Amgen's Blincyto Approved in Europe as Consolidation Treatment for Certain Newly Diagnosed ...
The EC's decision was based on results from a Phase III trial of Blincyto with multiphase consolidation chemotherapy.
precisionmedicineonline
2 天
Roche Looks Forward to Itovebi Approval in Europe Amid Steady Q4 Revenue Growth
The firm will share new overall survival data from the INAVO120 trial with regulators to support the breast cancer drug's approval.
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