Tag: FDA

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.

PETACH TIKVA, Israel, June 17, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that following its recently announced successful SHIELD II phase 3 topline results, it has secured additional funding through the exercise of warrants with aggregate gross proceeds of $26.7 million. The Company anticipates that with this additional funding, PolyPid’s runway would be extended beyond anticipated FDA approval of D-PLEX₁₀₀.

Advanced Dental Center Expands Full-Mouth Restoration and Gum Disease Treatment with Modern Tools

TORONTO, June 16, 2025 (GLOBE NEWSWIRE) -- MediPharm Labs Corp. (TSX: LABS) (OTCQB: MEDIF) (FSE: MLZ) (“MediPharm” or the “Company”), a pharmaceutical company specialized in precision-based cannabinoids, wishes to respond to a misleading press release published earlier today by Apollo Technology Capital Corporation (“Apollo”) prematurely claiming that it considers the results of the annual and special meeting of shareholders scheduled to take place at 3:00 p.m. today (the “Meeting”) to be a clear victory for Apollo.

MALVERN, Pa., June 16, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) amendment to initiate a Phase 2/3 pivotal confirmatory trial of OCU410ST, a modifier gene therapy candidate being developed for all Stargardt disease (ABCA4-associated retinopathies). The FDA previously granted Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation for OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt disease, retinitis pigmentosa 19, and cone-rod dystrophy 3.

ROCKVILLE, Md. and SUZHOU, China, June 15, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global biopharmaceutical company dedicated to addressing unmet medical needs in cancers, announced that results from 13 studies of its core assets, including the novel drug olverembatinib (HQP1351) and the investigational EED inhibitor APG-5918, have been reported at the 2025 European Hematology Association (EHA) Annual Congress.