FDA, Telix agree on NDA resubmission pathway for TLX101-CDx, an investigational agent for glioma imaging

FDA cracks down on direct-to-consumer ads, including the Hims & Hers Superbowl blitz

FDA has begun to crack down on direct-to-consumer prescription drug advertising.

September 19, 2025

FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer

FDA approved gemcitabine intravesical system (Inlexzo) for adults with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.

September 19, 2025

Vol.51 No.34

Drugs & Targets

FDA approves Bosaya and Aukelso, denosumab biosimilars, for osteoporosis

FDA approved Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq) injections, biosimilars of Prolia and Xgeva respectively, for the treatment of osteoporosis. In addition, FDA granted provisional interchangeability designation for both Bosaya and Aukelso.

September 19, 2025

Vol.51 No.34

Drugs & Targets

FDA approves selumetinib for pediatric neurofibromatosis indication

FDA approved selumetinib (Koselugo) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas. FDA previously approved selumetinib capsules for pediatric patients 2 years of age and older with NF1 who have symptomatic, inoperable PN.

September 19, 2025

Vol.51 No.34

Cancer Policy

Vinay Prasad regains role as FDA chief medical and scientific officer

Vinay Prasad has regained his role as FDA’s chief medical and scientific officer, according to an update on the agency’s website.

September 12, 2025

Vol.51 No.33

By Claire Marie Porter

Cancer Policy

FDA advances rare disease drug development with new evidence principles

FDA introduced the Rare Disease Evidence Principles to provide greater speed and predictability in the review of therapies intended to treat rare diseases with very small patient populations with significant unmet medical need and that are driven by a known genetic defect.

September 12, 2025

Vol.51 No.33

By Jacquelyn Cobb