Tag: FDA

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.

Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $100,000 In Sarepta To Contact Him Directly To Discuss Their Options

Public curiosity around nerve health is rising in 2025, with searches, podcasts, and social platforms highlighting natural approaches. Nerve Soothe enters this conversation with a formula designed around ingredient transparency, plant-based extracts, and consumer-driven expectations for wellness support.

Bagsværd, Denmark, 15 August 2025 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved an additional indication for Wegovy^® (semaglutide 2.4 mg) based on a supplemental New Drug Application (sNDA) for treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), in combination with a reduced calorie diet and increased physical activity.

SAN FRANCISCO, Aug. 15, 2025 (GLOBE NEWSWIRE) -- On August 14, 2025 the price of Hims & Hers Health (NYSE: HIMS) shares significantly dropped in after-hours trading after the financial press reported that the FTC is probing the company’s advertising practices and whether it makes it too difficult for customers to cancel subscriptions.

Tonmya is the first FDA-approved therapy for the treatment of fibromyalgia in over 15 years

BOSTON, MASSACHUSETTS, Aug. 15, 2025 (GLOBE NEWSWIRE) -- BIOXYTRAN, INC. (OTCQB: BIXT) (the “Company”), a pioneering clinical stage biotechnology company at the forefront of oxygen therapeutics, is proud to announce a major scientific milestone: the publication of Body Oxygen Homeostasis and Mitochondrial Function from Animal Models to Clinical Applications by Prof. Avraham Mayevsky, a key advisor to Bioxytran. This groundbreaking work dives deep into the science of oxygen regulation and mitochondrial health – revealing transformative insights that could redefine treatment for stroke, Alzheimer’s, and other critical conditions.

https://link.springer.com/book/10.1007/978-3-031-94113-9

Virtual Events Include Investor Webinar and Presentation at Emerging Growth Conference 85

Jennifer Callahan, Chief Financial Officer, appointed Interim CEO