Tag: FDA

BOSTON, June 30, 2025 (GLOBE NEWSWIRE) -- PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AISight® Dx*—its digital pathology image management system—for use in primary diagnosis in clinical settings. Building on the initial 510(k) clearance for AISight Dx(Novo) in 2022, this latest milestone underscores the platform’s continuous innovation and PathAI’s commitment to delivering enhanced capabilities as the product evolves.

SAN DIEGO, June 30, 2025 (GLOBE NEWSWIRE) -- Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of Sarepta Therapeutics, Inc. (NASDAQ: SRPT) securities between June 22, 2023 and June 24, 2025, both dates inclusive (the “Class Period”), have until August 25, 2025 to seek appointment as lead plaintiff of the Sarepta class action lawsuit. Captioned Dolgicer v. Sarepta Therapeutics, Inc., No. 25-cv-05317 (S.D.N.Y.), the Sarepta class action lawsuit charges Sarepta and certain of Sarepta’s top executives with violations of the Securities Exchange Act of 1934.

— Approval based on Phase III SACHI Trial results which showed a 66% reduced risk of progression or death as compared to platinum-based chemotherapy —

The 2025 update explores how evolving consumer interest in brain fog, coffee-enhanced wellness routines, and ingredient transparency is shaping the future of cognitive support.

NEW YORK, June 27, 2025 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed in the United States District Court for the Southern District of New York on behalf of all persons or entities who purchased or otherwise acquired Sarepta Therapeutics, Inc. (“Sarepta” or the “Company”) (NASDAQ: SRPT) securities between June 22, 2023 and June 24, 2025, both dates inclusive (the “Class Period”).

PALM BEACH, Fla., June 27, 2025 (GLOBE NEWSWIRE) -- Today marks a significant milestone for theranos and its diagnostic technology. The theranos system performs automated sample processing and analysis to produce clinical test results. The U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has affirmed that the core technology is not under question.

NEW YORK, June 27, 2025 (GLOBE NEWSWIRE) --

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of PepGen Inc. (NASDAQ: PEPG) between March 7, 2024 and March 3, 2025, both dates inclusive (the “Class Period”), of the important August 8, 2025 lead plaintiff deadline.

Boca Raton, Florida, June 27, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company, today announced that it has entered into securities purchase agreements with two healthcare focused institutional investors for the purchase and sale of 3,000,000 shares of its common stock in a registered direct offering (the "Offering") at a purchase price of $6.30 per share, priced at-the-market under Nasdaq rules.