Seeking Alpha

Avant Technologies and JV Partner, Ainnova, Prepare for Key FDA Milestone with Next Week's Pre-Submission Meeting

LAS VEGAS, June 30, 2025 /PRNewswire/ -- Avant Technologies, Inc. (OTCQB: AVAI) ("Avant" or the "Company"), and its JV partner, Ainnova Tech, Inc., (Ainnova), a leading healthcare technology company ...
Business Insider

Opus Genetics Announces Successful FDA Meeting Supporting Advancement of OPGx-LCA5 Toward Pivotal Trial for LCA5-Related Inherited Retinal Disease

Outcome of Regenerative Medicine Advanced Therapy (RMAT) meeting provides the potential for an accelerated regulatory pathway to approval of OPGx-LCA5 First participant enrolled in run-in period for ...
JD Supra

FDA PreCheck meeting weighs how more clarity may help de-risk US manufacturing investments - Agency invites additional comments on PreCheck in public docket

At a September 30, 2025, public meeting hosted by the U.S. Food and Drug Administration (FDA), industry stakeholders expressed strong support for the newly launched FDA PreCheck Program, while raising ...
Hosted on MSN

Lawmakers invited to FDA meeting for Soon-Shiong’s drug

(Bloomberg) -- Two Republican lawmakers were invited to attend a Food and Drug Administration meeting about the potential expanded approval of a drug backed by billionaire Patrick Soon-Shiong, but the ...
Seeking Alpha

Capricor Therapeutics Announces Completion of Mid-Cycle Review Meeting with FDA on Deramiocel for the Treatment of Duchenne Muscular Dystrophy Cardiomyopathy

-Advisory committee meeting to be held in advance of target action date- SAN DIEGO, May 05, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (CAPR) (NASDAQ: CAPR), a biotechnology company developing ...
MedTech Dive

Medtech industry calls for FDA staffing transparency in MDUFA talks

Medical device lobbyists called for more staffing transparency in user fee negotiations with the Food and Drug Administration ...