Adcomms

Pictured: FDA signage at its office in Washington, DC

Policy

FDA Questions Benefit, Risk Profile of Geron’s MDS Candidate Ahead of Adcomm

In a briefing document for Thursday’s advisory committee meeting, the FDA pointed to efficacy and safety issues with Geron’s New Drug Application for imetelstat in myelodysplastic syndromes.

March 13, 2024

2 min read

Tristan Manalac

Pictured: FDA sign at its office in Washington, DC/iStock, JHVEPhoto

Policy

FDA Sets Adcomm for BMS, J&J CAR T Therapies Amid Class-Wide Safety Concerns

The FDA’s Oncologic Drugs Advisory Committee will meet on March 15 to discuss BMS and J&J applications for their CAR T-cell therapies Abecma and Carvykti, respectively.

February 5, 2024

2 min read

Tristan Manalac