Search Results
Aug 18, 2026, 03:00 ET Amygdala Neurosciences Announces FDA Clearance of Investigational New Drug (IND) Application for ANS-858
Aug. 18, 2026 /PRNewswire/ -- Amygdala Neurosciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for ANS-858, enabling the Company to advance ANS-858 into clinical development.
More news about: Amygdala Neurosciences Inc.
Aug 18, 2026, 02:15 ET Hansa Biopharma announces first commercial kidney transplant patient treated with Idefirix in Australia
follow-up study and one post-approval efficacy study.In the US, the Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for imlifidase in February of 2026 and assigned a Prescription Drug User Fee Act (PDUFA) action date of December 19, 2026.Full EU product information
More news about: Hansa Biopharma AB
Aug 18, 2026, 02:12 ET Hansa Biopharma announces first commercial kidney transplant patient treated with Idefirix in Australia
follow-up study and one post-approval efficacy study.In the US, the Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for imlifidase in February of 2026 and assigned a Prescription Drug User Fee Act (PDUFA) action date of December 19, 2026.Full EU product information
More news about: Hansa Biopharma AB
Aug 18, 2026, 00:03 ET WuXi XDC Achieves GMP Release of BCM3 Facility at Singapore Site, Enabling Global Clients with Professional Excellence
end-to-end commercial manufacturing services from antibody intermediates to conjugated drug substances. The production line supports batch sizes from 200 L to 2,000 L for antibody intermediates and up to 2,000 L for conjugated drug substances, fully meeting commercial-scale requirements while adhering to a rigorous
More news about: WuXi XDC
Aug 17, 2026, 22:07 ET Rosen Law Firm Encourages Disc Medicine, Inc. Investors to Inquire About Securities Class Action Investigation - IRON
action.What is this about: On February 13, 2026, the U.S. Food and Drug Administration ("FDA") issued a Complete Response Letter ("CRL") to Disc Medicine regarding its bitopertin program. The FDA stated they could not approve Disc Medicine's new drug application ("NDA") as there were uncertainties in the NDA
More news about: THE ROSEN LAW FIRM, P. A.
Aug 17, 2026, 17:18 ET In HelloNation, Criminal Defense Attorney Frank Walker Explains the Difference Between Misdemeanor and Felony Charges
convictions can bring even more severe and lasting consequences. Under Pennsylvania law, felonies include crimes such as robbery, aggravated assault, or drug trafficking. These convictions can result not only in lengthy prison sentences but also in restrictions on voting, firearm ownership, and future job
More news about: HelloNation
Aug 17, 2026, 16:56 ET AARD Stockholder Notice: Robbins LLP Reminds Investors of the Class Action Lawsuit Against Aardvark Therapeutics, Inc.
2, 2026.Then, on May 14, 2026, Aardvark issued a press release "announc[ing] that the U.S. Food and Drug Administration (FDA) has placed a full clinical hold on its investigational new drug application (IND) for ARD-101 related to the Company's previously announced voluntary pause." The press release
More news about: Robbins LLP
Aug 17, 2026, 15:56 ET La función Hearing Aid de los Galaxy Buds de Samsung recibe la aprobación de la FDA
agosto de 2026 /PRNewswire/ -- Samsung Electronics anunció que la función Hearing Aid de sus Galaxy Buds recibió la aprobación de la Food and Drug Administration (FDA) de Estados Unidos. Esta función permite que los Galaxy Galaxy Buds1 compatibles funcionen como un audífono de venta
More news about: Samsung Mexico
Aug 17, 2026, 11:58 ET Lupin Announces Approval from U.S. FDA for Pitolisant Tablets
(REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced that it has received the final approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Pitolisant Tablets, 4.45 mg and 17.8 mg.
More news about: Lupin Pharmaceuticals, Inc.
Aug 17, 2026, 11:00 ET SERVING A SECOND SET: VITAL PROTEINS® RETURNS AS THE OFFICIAL COLLAGEN PARTNER OF THE US OPEN WITH SKIN IN THE GAME
forefront of its business – and achieved B Corp™ certification in 2022. Today, Vital Proteins products can be found in mass retailers, grocery and chain drug stores as well as natural food markets in more than 25 countries. For more information, please visit
More news about: Vital Proteins
Aug 17, 2026, 10:32 ET Hypertrophic Cardiomyopathy Market Set for Transformation Over the Next Decade with the Emergence of Targeted Cardiac Therapies Beyond Conventional Beta-blockers, Calcium Channel Blockers, and Antiarrhythmic Agents | DelveInsight
announced the US FDA accepted a supplemental New Drug Application (sNDA) for Mavacamten as a potential treatment for adolescents (ages 12 years to <18 years) with symptomatic oHCM. The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) date of September 30,
More news about: DelveInsight Business Research, LLP
Aug 17, 2026, 09:15 ET Galmed Announces First Time Results in Prostate Oncology Studies: Aramchol Demonstrates 3-4 Fold Increase in Cell Death Compared to Enzalutamide (XTANDI®) Alone in Prostate Cancer Models
blocker) with an SCD1 inhibitor blocks this lipid synthesis and desaturation, potentially leading to decreased cell viability, and delayed development of drug resistance.The data we present today, demonstrate that a combination of Aramchol (an SCD1 inhibitor) with enzalutamide resulted in 3–4-fold increase
More news about: Galmed Pharmaceuticals Ltd.
Aug 17, 2026, 09:00 ET Connext Completes Enrollment in Phase 2 Trial of CNT201 in Dupuytren's Contracture
late 2026.Connext initiated the Phase 1/2 clinical trial of CNT201 in 2024 following clearance of its investigational new drug application by the U.S. Food and Drug Administration. The Phase 1 portion of the trial confirmed the safety and tolerability of CNT201, supporting advancement into Phase
More news about: Connext
Aug 17, 2026, 09:00 ET Ispire Technology Inc. Appoints Steven Przybyla as President
biotechnology company, where he helped secure the only Modified Risk Tobacco Product authorization for a combustible cigarette granted by the U.S. Food and Drug Administration to date. Previously, he was President of the Medical Division at Jushi, Inc., a multi-state cannabis operator, from 2018 to 2020; General
More news about: Ispire Technology Inc.
Aug 17, 2026, 08:39 ET Dongguk University Researchers Develop Innovative Electromagnetically Controllable Gene Switch
electrical signals. However, current versions are limited in offering precise control over the timing and duration of gene expression. Additionally, drug-based gene switches can have undesirable adverse effects, while some stimuli such as light can make penetrating deeper tissues challenging.Addressing
More news about: Dongguk University
Aug 17, 2026, 08:34 ET YMX's Adam Buttgenbach Honored as Fleet Innovator Amid Growing Focus on Optimized and Autonomous Yard Operations
analytical reporting on major issues such as the latest EPA diesel emissions standards, the corrosive dangers of newfangled road de-icers, employee drug testing, counterfeit parts, fuel quality problems, driver fatigue, the highway funding debate, the fuel price crisis and more.Truckinginfo.comTruckinginfo.com
More news about: YMX Logistics
Aug 17, 2026, 08:30 ET Insilico Medicine Included in MSCI Global Small Cap Indexes, Gaining Capital Market Endorsement in Core Strengths
been included into several major index series, including the China Securities Index (CSI) Series (CSI Hong Kong Connect Innovative Drug Index, CSI Hong Kong Brand Name Drug Index, and CSI HK Connect Health Care Composite Index), Hang Seng Composite Index, Hang Seng Healthcare Index, Hang Seng Biotechnology
More news about: Insilico Medicine
Aug 17, 2026, 08:30 ET The9 Limited to Report Second Quarter 2026 Results on August 24, 2026
continues to explore emerging opportunities across AI-empowered industries and the broader digital ecosystem, including an equity stake in AI-driven drug discovery company NYB, building a multi-engine business positioned at the frontier of AI and the new economy, reshaping how value is created and shared.
More news about: The9 Limited
Aug 17, 2026, 08:30 ET Access Program Process Changes to Increase Speed to Therapy, Upcoming Webinar Hosted by Xtalks
drive every hub vendor evaluation, the performance signals that most brands are not monitoring closely enough and the operational realities of specialty drug access (and where automation can help or hurt).Drawing on direct experience with hub program transitions and vendor assessments, this webinar
More news about: Xtalks
Aug 17, 2026, 08:30 ET A Practical Guide to Conducting In-Trial Patient Interviews, Upcoming Webinar Hosted by Xtalks
TORONTO, Aug. 17, 2026 /PRNewswire/ -- Regulators increasingly would like to see the patient voice included to inform drug development, and in-trial patient interviews are one of the most direct ways to capture it. Done well, they transform patient experience into evidence
More news about: Xtalks
Aug 17, 2026, 08:04 ET First Ascent Biomedical Names Dr. Gilberto Lopes Chairman of Its Medical Advisory Board
precision oncology company developing patient-specific cancer treatment decision support. Its xDRIVE Ex Vivo Drug Response Identification & Validation Engine combines live-cell functional drug-response testing, genomic DNA and RNA information and machine-learning-guided analysis to provide treating
More news about: First Ascent Biomedical
Aug 17, 2026, 08:01 ET Acurx Pharmaceuticals Receives FDA Conditional Acceptance and USPTO Trademark Allowance for the Company's Brand Name for Ibezapolstat
biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, today announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proposed proprietary, or brand name, CIFBEZY for ibezapolstat, the Company's lead antibiotic product
More news about: Acurx Pharmaceuticals, Inc.
Aug 17, 2026, 08:00 ET 28bio Launches CNS-3D Plasticity Organoids to Assess Drug Effects on Human Learning and Memory
options for evaluating a drug candidate's effect on learning and memory. The Network Potentiation Assay measures how a drug candidate affects potentiation, the strengthening of neural connections that underlie learning and memory. The Synaptic Plasticity Assay measures a drug candidate's effect on reward-based
More news about: 28bio
Aug 17, 2026, 08:00 ET Labcorp to Host Investor Day on September 10, 2026
clear and confident decisions. We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities. The company's nearly 71,000 employees serve clients in approximately 100 countries, provided support for more than
More news about: Labcorp Holdings Inc
Aug 17, 2026, 08:00 ET OncoC4 Announces First Patient Dosing in Phase 1 Clinical Trial of ONC-783 for the Treatment of Advanced Solid Tumors
medicines for cancer and neurodegenerative diseases, today announced dosing of the first patient following the clearance of the Investigational New Drug (IND) application for a Phase 1 clinical trial (NCT07408258) of ONC-783, the company's investigational T-cell engager developed based on the proprietary
More news about: OncoC4