Tag: FDA

SEATTLE and VANCOUVER, British Columbia, June 30, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence for smoking cessation, today announced the closing of its underwritten public offering of 15,000,000 shares of its common stock and accompanying common warrants to purchase up to 16,766,666 shares of common stock at a public offering price of $3.00 per share and accompanying warrant, which includes common warrants to purchase up to 1,766,666 shares issued upon the partial exercise by the underwriters of their option to purchase additional shares of common stock and/or accompanying warrants. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, were $45.0 million.

TORONTO, ONTARIO, June 30, 2025 (GLOBE NEWSWIRE) -- COSCIENS Biopharma Inc. (NASDAQ: CSCI; TSX: CSCI) (“COSCIENS” or the “Company”), a life sciences company developing and commercializing a diversified portfolio of cosmeceutical, nutraceutical and pharmaceutical products, today announced the voting results on the items of business considered at the virtual annual general and special meeting of shareholders of the Company (the “AGSM”) held today.

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”).