Actuate Therapeutics' elraglusib shows promise in metastatic pancreatic cancer. Upcoming FDA meeting may accelerate approval.

ALS Survival Data Type C Meeting: This meeting will review the long-term survival benefit from CNM-Au8 30 mg treatment compared to concurrently randomized controls from another Healey ALS Platform ...

Legal Matter/Strategic Company DecisionFDA Confirms Type B Meeting on Corticorelin Pivotal Phase 3 Study 31.07.2025 / 06:00 CET/CESTMEDIA RELEASELiestal, Switzerland– Curatis Holding AG (SIX: CURN) – ...

The FDA Type C meeting, scheduled for November 6, will focus on finalizing the design of the Phase 3 trial, a pivotal step toward securing approval for the drug.

The Type C meeting followed a productive End of Phase 2 meeting with FDA and the publication of Phase 2 data of eRapa in FAP at six months at Digestive Disease Week in May 2024 and 12 months data ...

On May 2, 2025, and notwithstanding the FDA’s invitation to submit the sBLA articulated by its leadership at the January Meeting, the FDA delivered an RTF letter.

HONG KONG and WENZHOU, China, June 9, 2025 /PRNewswire/ -- VivaVision Biotech (VivaVision), a late clinical-stage, privately-held biotech company focused on developing innovative ophthalmic drugs ...

Citius Pharmaceuticals (CTXR) announced that the company held a constructive in-person Type C meeting with the U.S. FDA. The meeting followed successful completion of the company’s pivotal Phase ...

This meeting follows CTI's receipt of the FDA's Office of New Drugs' response to CTI's appeal as announced on May 3, 2011, which allows CTI the opportunity to resubmit the NDA.

Clene Provides Regulatory Update Following Constructive FDA Type-C Meeting on Neurofilament Biomarker Analysis Plan and Confirms Two Additional FDA Meetings Jun. 30, 2025 8:00 AM ET Clene Inc. (CLNN) ...