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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.

Cancer Patients Have Partial Response With Drug
(05/28/2022)

The developer of this antibody just released the results of its dose evaluation in solid tumors, noted a Wedbush report.

A comparison of safety data shows this Phase 3 treatment candidate for liposarcoma differentiates itself from competitors with its superior safety profile, noted an Oppenheimer report.

FDA Approves New Skin Resurfacing Device
Source: Streetwise Reports (05/26/2022)

Apyx Medical Corp. shares traded 50% higher after the company reported it received U.S. FDA 510(k) clearance for its Renuvion Dermal Handpiece for use in specific cosmetic dermal resurfacing procedures.

"The positive results could drive physician adoption when scheduling colonoscopies for hard-to-prepare patients going forward," noted an H.C. Wainwright & Co. report.

The company is pursuing several strategies to boost revenue, including clinical trials to possibly expand the label of one of its approved dermatological drugs, noted a ROTH Capital Partners report.