Accelerated approval pathways stories

Oct 30, 2026

FDA approves Inovio's Voceryq for recurrent respiratory papillomatosis

The U.S. Food and Drug Administration has approved Inovio Pharmaceuticals' treatment Voceryq for recurrent respiratory papillomatosis, a rare throat disease. The approval sent Inovio's shares surging.

Oct 30, 20264 sources

Sep 21, 2026

FDA grants breakthrough therapy designation for DT120 ODT in depression treatment

The FDA has granted breakthrough therapy designation to Definium Therapeutics' DT120 Orally Disintegrating Tablet after preliminary clinical evidence showed significant improvements in treating major depressive disorder.

Sep 21, 20261 source

May 10, 2026

China's NHWD-870 Receives Breakthrough Therapy Designation for Rare NUT Carcinoma

Chinese innovative drug NHWD-870 has received Breakthrough Therapy Designation for NUT carcinoma, a rare and aggressive cancer that has historically had very poor outcomes. The designation represents a significant milestone for patients with this previously untreatable condition.

May 10, 20261 source

May 7, 2026

Sanofi Withdraws Diabetes Drug from FDA's Expedited Review Program After Political Interference

Sanofi requested the FDA remove its type 1 diabetes drug from Commissioner Marty Makary's new speedy drug review voucher program after a political appointee interfered with the review process.

May 7, 20261 source

Top claims

▪Recurrent respiratory papillomatosis is a rare condition caused by HPV types 6 and 11 that causes recurrent non-cancerous wart-like growths in the throat and airways, affecting speech and breathing.
▪Inovio Pharmaceuticals' application for Voceryq was supported by an early- to mid-stage study in adults with recurrent respiratory papillomatosis who had undergone two or more surgeries in the prior year.
▪Inovio Pharmaceuticals expects to submit a draft protocol for Voceryq's FDA-required confirmatory study by the end of 2026 and finalize the study design by mid-2027.

Subtopics

Drug Policy, Pricing & Approval4 Drug Approval and Clinical Trials3 Fast track designation3 Biotechnology1 Cancer & Oncology1 Cancer Treatment & Therapies1 Cancer Types1 Clinical trials1 Depression1 FDA considers first psychedelic drug approval1 FDA drug approval1 Healthcare Policy1 Immunotherapy1 Mental Health & Wellbeing1 Rare diseases1 Respiratory diseases1 Stress, Burnout & Well-being1

Related timelines