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Aug 11, 2026, 09:01 ET Neurolief Expands Veterans' Access to Prescription Neuromodulation for Depression and Migraine Through New VA Contract

professor of psychiatry, radiology and neurosciences at the Medical University of South Carolina (MUSC). "Proliv Rx gives us a rigorously studied, non-drug therapy that individuals can use at home under our care, and it lets us reach those who have run out of other answers and offer them a real chance to

More news about: Neurolief Inc.


Aug 11, 2026, 09:01 ET Neurolief Expands Veterans' Access to Prescription Neuromodulation for Depression and Migraine Through New VA Contract

professor of psychiatry, radiology and neurosciences at the Medical University of South Carolina (MUSC). "Proliv Rx gives us a rigorously studied, non-drug therapy that individuals can use at home under our care, and it lets us reach those who have run out of other answers and offer them a real chance to

More news about: Neurolief Inc.


Aug 11, 2026, 09:01 ET Datasea Announces FDA Registration and Device Listing for NeuroVibe Acoustic BCI Biofeedback System as a Class II 510(k)-Exempt Biofeedback Medical Device

("Shuhai Jingwei"), the Company's variable interest entity in China, has completed establishment registration and device listing with the U.S. Food and Drug Administration ("FDA") for its NeuroVibe Biofeedback System, including products NV-02 and NV-03. The products are listed under FDA product code HCC

More news about: Datasea Intelligent Technology Ltd.


Aug 11, 2026, 09:00 ET EIT Pharma Announces FDA Acceptance of New Drug Application for Lonafarnib for Treatment of Chronic Hepatitis D

a biotechnology company focused on developing therapies for infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for lonafarnib for the treatment of chronic hepatitis D.

More news about: EIT Pharma


Aug 11, 2026, 09:00 ET Mighty Therapeutics and University of Washington Team Named Milestone 2 Awardee in $101M XPRIZE Healthspan Competition

pipeline to directly address bioenergetic deficits at the source.In September 2025, Mighty marked a historic milestone with the U.S. Food and Drug Administration (FDA) approval of its first commercial therapy, establishing both the first FDA-approved treatment for Barth syndrome and the first FDA-approved

More news about: Mighty Therapeutics


Aug 11, 2026, 09:00 ET 10 Finalist Teams Awarded $1M to Advance in XPRIZE Healthspan $101 Million Race to Transform Healthy Aging

the competition and expand their therapeutic solutions even further - with highly accessible scalable solutions like foods and supplements, existing drug combinations, and even completely new breakthrough approaches that cross categories."Over the past several years, we've watched these teams transform

More news about: XPRIZE


Aug 11, 2026, 09:00 ET The Galien Foundation Announces 2026 Prix Galien USA Nominees for "Best Biotechnology Product," "Best Pharmaceutical Product," and "Best Product for Rare/Orphan Diseases"

the Galien Foundation received a record number of submissions across these three categories.To qualify, each candidate must be U.S. Food and Drug Administration (FDA) approved for marketing within the last five years and demonstrate tremendous potential to improve human health. Sales data are

More news about: The Galien Foundation


Aug 11, 2026, 08:31 ET Ceramedix Awarded Up to $4.5 Million NIAID Contract to Advance Lead GI-ARS Therapeutic Toward IND Submission

of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA).Ceramedix's proprietary anti-ceramide antibodies represent a significant breakthrough with the potential to enable lifesaving treatment of GI-ARS. The company's lead drug candidate is designed for subcutaneous

More news about: Ceramedix, Inc.


Aug 11, 2026, 08:30 ET The9 Investee Nanyang Biologics (NYB) Advancing Planned Nasdaq Listing for the US$1.5 Billion Business Combination

and Nasdaq approval.NYB is a Singapore-headquartered, AI-first drug discovery company focused on natural compounds. At the center of its platform is a library cataloging over one million natural compounds, and DTIGN, a Drug-Target Interaction Graph Neural Network that predicts how natural compounds

More news about: The9 Limited


Aug 11, 2026, 08:00 ET Kalohexis Appoints Life Sciences Leader, Jeffrey Sherman, MD, to Board of Directors

Squibb. He was the former board chairperson and now inaugural fellow of the Drug Information Association (DIA), a board member of the Center for Healthcare Innovation, and a past steering committee member of the U.S. Food and Drug Administration (FDA)-sponsored Clinical Trial Transformation Initiative (CTTI). "Kalohexis'

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Aug 11, 2026, 08:00 ET Bracco Marks Major Global Milestone with U.S. FDA 510(k) Clearance and Health Canada Authorization for VueJect®, the First Dedicated Ultrasound Contrast Delivery System to Support Cardiology Imaging

dedicated ultrasound contrast delivery system engineered to support cardiology imaging specifically, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and authorization from Health Canada. These regulatory milestones represent the first step in Bracco's broader global commercialization

More news about: Bracco Group


Aug 11, 2026, 08:00 ET Sentynl Therapeutics and Mereo BioPharma Announce Option and License Agreement for alvelestat in Alpha-1 Antitrypsin Deficiency-Associated Lung Disease (AATD-LD)

bronchiectasis, cystic fibrosis, COVID-19 and bronchiolitis obliterans syndrome following allogeneic stem cell transplant.Alvelestat has received Orphan Drug Designation for AATD-LD from the European Commission and the FDA. It has also received Fast Track designation from the FDA.About Zydus Lifesciences

More news about: Sentynl Therapeutics


Aug 11, 2026, 08:00 ET Novo Nordisk's Awiqli®, the first once-weekly basal insulin for adults with type 2 diabetes, now available in the US

adjunct to diet and exercise to improve glycemic control (blood sugar) in adults living with type 2 diabetes,1 following the U.S. Food and Drug Administration (FDA) approval earlier this year."Awiqli® represents meaningful progress in the options available for basal insulin

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Aug 11, 2026, 07:50 ET SLENYTO® (melatonin extended-release tablets) is now available in Canada as a prescription treatment for insomnia in children and adolescents with autism spectrum disorder (ASD) and/or Smith-Magenis syndrome (SMS).

the discovery and development of groundbreaking new medicines for disorders related to the central nervous system (CNS). With a proven track record of drug development and commercialization, Neurim's first products, Circadin® and Slenyto®, are already in use in more than 40 countries across 5 continents.

More news about: Kye Pharmaceuticals Inc.


Aug 11, 2026, 07:30 ET Intensity Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Update

skin irritation near the tumor site. In March 2026, a protocol amendment was approved by the Swissmedic and the Swiss Ethics Committee to use a lower drug volume per tumor volume ratio and a single injection of INT230-6 in Cohort A.  In August 2026, the Company opened its first site in France for accrual

More news about: Intensity Therapeutics Inc.


Aug 11, 2026, 07:00 ET RazorMetrics Named to Inc. 5000 Fastest-Growing Companies List for Second Consecutive Year

strong growth driven by increasing demand from health plans, employers, PBMs, and other organizations seeking practical ways to reduce prescription drug spend without placing more burden on patients or disrupting provider workflows."Being named to the Inc. 5000 for a second consecutive year is

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Aug 11, 2026, 07:00 ET Transpire Bio's Dr. Lei Mao Appointed as Board Chair of the IPAC-RS for its 2026-2028 Term

election reflects both his individual and scientific expertise and highlights Transpire Bio's position as a global thought leader in inhalation and inhaled drug-device combination products. We believe engagement with organizations such as IPAC-RS is important in shaping the scientific and regulatory environment

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Aug 11, 2026, 06:30 ET Immunic, Inc. Reports Second Quarter 2026 Financial Results and Provides Corporate Update

which was related to non-cash stock compensation, (ii) a $3.9 million increase due to drug-drug interaction studies in support of a potential NDA filing, (iii) a $3.1 million increase for vidofludimus calcium drug supply and (iv) a $1.3 million increase related to costs across numerous categories, partially

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Aug 11, 2026, 06:30 ET CAPR INVESTOR DEADLINE: Capricor Therapeutics, Inc. Investors with Substantial Losses Have Opportunity to Lead Shareholder Class Action Lawsuit

allegedly failed to disclose that they adopted changes to the pre-specified statistical analysis plan (SAP) without agreement from the U.S. Food and Drug Administration (FDA) prior to resubmitting its Biologics License Application (BLA).The HOPE-3 Trial Breakthrough and Subsequent Capital RaiseOn

More news about: Hagens Berman Sobol Shapiro LLP


Aug 11, 2026, 06:00 ET Cambrex Milan Celebrates 80th Anniversary with Construction of New $30 Million R&D Facility

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical services.With over 45 years of experience and a

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Aug 11, 2026, 06:00 ET Cambrex Milan Celebrates 80th Anniversary with Construction of New $30 Million R&D Facility

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical services.With over 45 years of experience and a

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Aug 11, 2026, 05:45 ET Insilico Medicine Announces 2026 Interim Earnings Conference Call Dates

Aug. 11, 2026 /PRNewswire/ -- Insilico Medicine ("Insilico"; HKEX: 3696), a clinical-stage generative artificial intelligence (AI)-driven drug discovery company, today announced that it will hold conference calls to discuss its financial results for the six months ended June 30, 2026 and provide

More news about: Insilico Medicine


Aug 11, 2026, 02:57 ET Cost neutrality of BLC versus WLC in a real-world setting demonstrated by new OPTUM study in the U.S.

https://www.cancer.org/cancer/bladder-cancer.html About Hexvix®/Cysview® (hexaminolevulinate HCl)Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the bladder, making them glow bright pink during Blue Light Cystoscopy (BLC®). BLC with

More news about: Photocure


Aug 11, 2026, 02:52 ET Cost neutrality of BLC versus WLC in a real-world setting demonstrated by new OPTUM study in the U.S.

https://www.cancer.org/cancer/bladder-cancer.html About Hexvix®/Cysview® (hexaminolevulinate HCl)Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the bladder, making them glow bright pink during Blue Light Cystoscopy (BLC®). BLC with

More news about: Photocure


Aug 10, 2026, 21:30 ET Aureka Biotechnologies Raises US$100 Million Series B to Build a Biological World Model for Drug Discovery

models do not just solve individual drug discovery tasks; they learn the rules of biology, to understand, generate, predict and intervene in complex biological systems.As foundation models and automated R&D converge, Aureka is shifting from using AI to make drug discovery more efficient to using

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