Tag: FDA

CONSHOHOCKEN, Pa., June 17, 2025 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today announced that it granted equity awards on June 15, 2025 to 36 new non-executive employees as equity inducement awards under the terms of Madrigal’s 2023 Inducement Plan. The equity awards were approved by Madrigal’s independent Compensation Committee in accordance with Nasdaq Listing Rule 5635(c)(4).

– Veteran executive with over 20 years of oncology leadership and clinical experience with proven track record of success in bringing development candidates through late-stage clinical development –

Fast Track status enables expedited regulatory review timelines and supports the development of recombinant human plasma gelsolin (rhu-pGSN), a novel immune modulator for inflammatory diseases.

MELVILLE, N.Y., June 17, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage regenerative medicine innovator focused on stem cell-based therapies and products, today announced that its Board of Directors has authorized a stock repurchase program under which the Company may repurchase up to $2 million of its outstanding common stock through June 16, 2026.

SOUTH SAN FRANSCISCO, Calif., June 17, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”) an innovative immunotherapy company seeking to advance the next generation of  engineered T cell therapeutics that deploy phagocytic mechanisms, announces that the U.S. Food and Drug Administration (FDA) has granted CERo’s Orphan Drug Designation (ODD) for the company's lead drug candidate CER-1236, for the treatment of acute myeloid leukemia (AML). CER-1236 is an innovative therapy that engineers a cancer patient's own T cell therapeutics that deploy phagocytic (i.e., target-cell eating) mechanisms alongside the array of built-in target cell destroying mechanisms used by T cells.

NEW YORK, June 16, 2025 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that class actions have been commenced on behalf of stockholders of Reckitt Benckiser Group plc (OTC:RBGLY), UroGen Pharma Ltd. (NASDAQ:URGN), Red Cat Holdings, Inc. (NASDAQ: RCAT) and Fortrea Holdings Inc. (NASDAQ:FTRE). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link provided.