The Approval Process in Action

Life Sciences Tools & DiagnosticsMedical DevicesRegenerative MedicineBiotechnology / Pharmaceuticals

Source: The Life Sciences Report and Visual Capitalist (5/1/13)

What catalysts in the drug development process move biotech company stocks? The savvy investor must know what steps in the U.S. Food and Drug Administration's approval process can propel a stock up or down. From drug discovery to the much-anticipated PDUFA date, The Life Sciences Report and the Visual Capitalist have collaborated on an infographic that describes both the process and related catalysts.

New Drug for Duchenne Muscular Dystrophy Nears Potential Approval
Source: James Molloy (10/06/2025)

Capricor Therapeutics Inc. (CAPR:NASDAQ) could receive a PDUFA date for its cell therapy as early as spring 2026 if it follows the FDA-outlined path forward, noted an Alliance Global Partners report.

Clean Tech Co.'s 'Forever Chemical' Solution Is a PFAS Breakthrough
Source: Streetwise Reports (10/02/2025)

Clean technology company BioLargo Inc. (BLGO:OTCQX) announced compelling new findings about its proprietary Aqueous Electrostatic Concentration (AEC) "forever chemicals" solution. Read to discover why one expert thinks the breakthrough is important to the company's future.

Biotech Battles FDA, Target Price Shows Potential 90% Gains
Source: Dr. Boobalan Pachaiyappan (10/01/2025)

Capricor Therapeutics Inc. (CAPR:NASDAQ) has recently been involved in a "tug-of-war with the FDA." Read on to see why one Roth analyst still rates this stock as a Buy.

Biotech Secures FDA Alignment on Late-Stage Duchenne Therapy
Source: Streetwise Reports (10/01/2025)

Capricor Therapeutics Inc. (CAPR:NASDAQ) reached agreement with the FDA to include HOPE-3 trial data in its BLA for Deramiocel, its cell therapy for Duchenne muscular dystrophy. With topline results due in Q4, learn how the company is advancing one of the few late-stage programs in this high-need rare disease space.

Pharma's Flu Drug Could Be Worth Billions, Analyst Says
Source: Brian Abrahams (09/29/2025)

Cidara Therapeutics Inc. (CDTX:NASDAQ) shares the minutes from an important meeting with the FDA, and the overall feedback was encouraging. Find out what one analyst predicts that will mean for Phase III development.