The FDA has approved a label update for an inhaled insulin indicated for adults with type 1 or type 2 diabetes, according to ...
FDA labeling now recommends DPYD variant testing before initiating capecitabine or 5-FU, except when immediate treatment is ...
FDA allows “no artificial colors” claims for natural dyes, but undefined “petroleum-based” categories leave manufacturers ...
On January 12, NP-G2-044 (Prilukae), a novel oral fascin inhibitor earned ODD for the treatment of pancreatic cancer. This designation covers the use of the agent as monotherapy and in combination ...
FDA assigns Prescription Drug User Fee Act (PDUFA) target date of June 29, 2026Ended 2025 with unaudited cash position of $41 ...
Company highlights accelerating access and revenue growth for ARBLI™ and confirms REZENOPY™ launch timeline, addressing a combined US annual losartan and naloxone market size of close to $385 million ...
The company said that the FDA hold has impacted two experimental gene therapies, RGX-111 and RGX-121. ・REGENXBIO added that ...
- a single-arm, open-label registrational trial in 2nd-line refractory high-grade NMIBC with CIS - a randomized vs observation single trial in intermediate-risk NMIBC in the adjuvant setting Phase 3 ...
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