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CAPR updates FDA on Deramiocel BLA, plans HOPE-3 CSR filing in February

Capricor Therapeutics CAPR recently provided a regulatory update on its Biologics License Application (BLA) for Deramiocel, ...
Business Insider

BioRestorative Granted Type B Meeting with FDA to Discuss Accelerated BLA Approval Pathway for BRTX-100 in Chronic Lumbar Disc Disease

MELVILLE, N.Y., Nov. 17, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX) , a ...

Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA Following FDA Review of HOPE-3 Topline Data

FDA has requested the HOPE-3 clinical study report (CSR) as part of the BLA review processCompany expects to submit updates to the BLA in ...

Sangamo Therapeutics Initiates Rolling Submission of BLA to U.S. FDA for ST-920 in Fabry Disease

Detailed price information for Sangamo Therapeutics (SGMO-Q) from The Globe and Mail including charting and trades.
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

INO-3107 At The Crossroads: FDA Review Drives Inovio's Upside And Risk

Inovio Pharmaceuticals faces an October 30 PDUFA date for INO-3107 with high regulatory risk and only a 5-7 month cash runway. Read why INO stock is a hold.