Tag: FDA

MINNEAPOLIS, June 03, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC) (“Celcuity” or the “Company”), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, today announced the pricing of its upsized underwritten public offering of $500,000,000 aggregate principal amount of its 0.250% convertible senior notes due 2032 (the “Convertible Notes”). The aggregate principal amount of the offering was increased from the previously announced offering size of $400,000,000.

The global leader within intimate healthcare today announced FDA approval of Titan Prime, an inflatable penile prosthesis (IPP) that represents the company’s next-generation device and will be available in the U.S. in late 2026. 

ניו יורק, June 03, 2026 (GLOBE NEWSWIRE) --

מדוע: משרד רוזן עורכי דין (Rosen Law Firm), משרד עורכי דין בינלאומי העוסק בזכויות משקיעים, ממשיך לחקור תביעות ניירות ערך פוטנציאליות מטעם בעלי המניות של Disc Medicine, Inc (נאסד"ק: IRON) הנובעות מטענות לפיהן יתכן ש-  Disc Medicine פרסמה מידע עסקי מטעה באופן מהותי לציבור המשקיעים.

- The INDIGO study met its primary and all key secondary endpoints with statistically significant results -

NULISA™ DBS Extraction Kit recovers proteins from dried blood spot and dried plasma spot microsamples collected on leading third-party remote sampling devices 

ROCKVILLE, Md. and SUZHOU, China, Aug. 17, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced that it has received clearance by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to conduct GLORA-4 study (NCT06641414), a global registrational Phase III study of lisaftoclax (APG-2575), a proprietary Bcl-2 inhibitor, in combination with azacitidine (AZA), for the treatment of patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS).

NEW YORK, Aug. 17, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Biohaven Ltd. (“Biohaven” or the “Company”) (NYSE: BHVN) and certain officers. The class action, filed in the United States District Court for the District of Connecticut, and docketed under 25-cv-01120, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Biohaven securities between March 24, 2023 and May 14, 2025, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 sand Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.