FDA Fast-Tracks Vera's At-Home Kidney Drug

Vera Therapeutics stock rose on FDA acceptance of atacicept BLA for priority review in IgAN, a potential multi-billion dollar ...

OTLK Stock Crashes 67% in a Week: Here's What You Need to Know

Outlook Therapeutics stock plunges 67% in a week after the FDA issues a third CRL rejecting its ONS-5010 BLA for wet AMD, again seeking confirmatory data.

FDA Denies Approval of Outlook Therapeutics' ONS-5010 BLA: Key Takeaways

A complete response letter is a formal communication from the FDA indicating that an application cannot be approved in its present form. In the case of Outlook Therapeutics, the FDA noted that while ...
Ophthalmology Times

FDA update: Outlook Therapeutics receives CRL for resubmitted ONS-5010 BLA

The FDA issued a CRL for ONS-5010, citing the need for additional confirmatory efficacy evidence despite previous trials ...
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 ...
Seeking Alpha

Sangamo Therapeutics Announces FDA Acceptance of BLA Rolling Submission Request for ST-920 in Fabry Disease

RICHMOND, Calif., Nov. 21, 2025 (GLOBE NEWSWIRE) -- Sangamo Therapeutics, Inc. (SGMO), a genomic medicine company, today announced that the U.S. Food and Drug Administration (FDA) has accepted Sangamo ...
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 ...
Zacks Investment Research on MSN

3 biotech stocks with major 2026 catalysts

The biotech sector staged a robust comeback in 2025, with the Nasdaq Biotechnology Index climbing 33.8%. Although concerns ...