Precision Medicine Online

1 week ago | precisionmedicineonline.com | Alexandra Byrne

NEW YORK – Drugmakers will soon be able to compete for a new accelerated review program established this week by the US Food and Drug Administration aimed at therapeutic programs that align with national health priorities, according to the agency.

1 week ago | precisionmedicineonline.com | Alexandra Byrne

NEW YORK – Drugmakers will soon be able to compete for a new accelerated review program established this week by the US Food and Drug Administration aimed at therapeutic programs that align with national health priorities, according to the agency.

1 week ago | precisionmedicineonline.com | Alexandra Byrne

NEW YORK – Lyell Immunopharma announced new clinical data Tuesday from a Phase I/II trial of its dual-targeted CD19/CD20 CAR T-cell therapy for relapsed or refractory large B-cell lymphoma. The company highlighted the durability of the therapy and said it would improve outcomes for high-risk patients but chose to narrow the focus of the Phase II portion to later-line CAR-T naïve patients as it faces a crowded field of similar therapies.

2 weeks ago | precisionmedicineonline.com | Alexandra Byrne

NEW YORK – When she was in medical school, Lauren Merz was asked to write a case report about a patient of Egyptian descent who was said to have something then called "benign ethnic neutropenia." The disorder was described to her as one in which an individual has a low neutrophil count with no added risk of infection. As she researched more, Merz realized the term was a gross misnomer.

2 weeks ago | precisionmedicineonline.com | Turna Ray

NEW YORK – Two newly minted leaders at the US Food and Drug Administration have drafted a new set of priorities for the agency, including modernizing the review process for drugs and devices and addressing the high cost of treatments.