Home ••• Newswires by Industry • Countries • U.S. States • World Media Directory

FDA News ••• Topics • Countries • U.S. States

Europe FDA News ••• Topics • Europe Media Directory

Europe FDA Newswire

Get by Email • RSS

Published on 03:45 GMT

Health Check: Oncosil scores rare FDA win with bile duct cancer

Oncosil says it has scored a monumental FDA win with its bile duct cancer treatment – but investors are keeping a lid on it. Pic: Getty Images The FDA has approved Oncosil’s device under the Humanitarian Device Exemption pathway ACL attests to tough times …

Source: Stockhead - Neutral
Published on 10:22 GMT

EMA validates Pfizer and Valneva’s Lyme disease vaccine

The European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) from Pfizer and Valneva for their Lyme disease vaccine candidate, PF-07307405. With this validation, the agency will begin its formal assessment of the …

Source: Yahoo News - Center-left
Published on 05:15 GMT

The Cost of Keeping China Out

Travelers returning from China often report having seen the future. The country’s advances in frontier commercial technologies are visible in the robots that make and serve food in restaurants; the drones that deliver food and medicine; and the deployment …

Source: Foreign Affairs - Pending
Published on 13:06 GMT

Genitourinary Drugs Market to reach USD 38.29 Billion by 2035 at 1.72% CAGR

Genitourinary Drugs Market to Surge from USD 32.84 Billion in 2026 to USD 38.29 Billion by 2035—By Demographic Aging, Precision Biologics in Bladder Cancer NY, CA, UNITED STATES, August 17, 2026 /⁨EINPresswire.com⁩/ -- As per Market Research …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on 05:01 GMT

Henlius and Sandoz Enter Strategic Collaboration to Unlock Global Value of Biosimilars Platform

Collaboration may cover up to 10 proposed monoclonal antibody (mAb) and/or antibody-drug conjugate (ADC) biosimilar assets, with the majority of programs at early development stages Based on the initial arrangements, the total invoiced amount expected …

Source: The AI Journal - Pending
Published on 09:21 GMT

/C O R R E C T I O N -- The Galien Foundation/

In the news release, The Galien Foundation Announces 2026 Prix Galien USA Nominees for "Best Digital Health Solution," "Best Medical Technology," "Incubators, Accelerators and Equity," and "Best Startup", issued 13- …

Source: WFMZ - Pennsylvania - Neutral
Published on 06:28 GMT

How AI-enabled Software as Medical Devices are Reshaping Regulatory Routes and Medicine

FDA authorisations of AI-enabled software as medical devices (SaMDs) have increased significantly in recent years. Over 1,500 AI-enabled medical devices were FDA authorised as of April 2026. The majority (97%) of those authorisations happened within the …

Source: BioSpace - Pending
Published on 06:17 GMT

Built to bridge: Joe Henein

Sixteen years ago, Joe Henein wasn’t stepping into a neatly defined CEO role. Instead, he was building something that didn’t yet exist the way he envisioned it. “I started NewBridge Pharmaceuticals,” he tells The CEO Magazine. “I am the operational founder …

Source: The CEO Magazine - Neutral
Published on 03:47 GMT

Orthofix Medical Sees Reimbursement Rebound, but Spine Slump Clouds Outlook

Orthofix Medical (NASDAQ:OFIX) executives said the company’s updated outlook reflects the restoration of bone growth stimulation reimbursement, improving trends in biologics and limb reconstruction, and an expected European inventory order, partly offset …

Source: Nasdaq - Neutral
Published on 11:34 GMT

TAGRISSO® (osimertinib) plus savolitinib demonstrated statistically significant and clinically meaningful improvements ...

WILMINGTON, Del.--(BUSINESS WIRE)--Aug 17, 2026-- Positive high-level results from the SAFFRON Phase III trial showed TAGRISSO ® (osimertinib) plus savolitinib demonstrated a statistically significant and clinically meaningful improvement in both …

Source: The Barre-Montpelier Times Argus - Vermont - Pending
Published on 13:06 GMT

Hernia Repair Market to reach USD 7.17 Billion by 2035 at 4.6% CAGR

Hernia Repair Market to Surge from USD 4.78 Billion in 2026 to USD 7.17 Billion by 2035—Powered by Robotic-Assisted Adoption, Outpatient Reimbursement Expansion NY, CA, UNITED STATES, August 17, 2026 /⁨EINPresswire.com⁩/ -- As per Market Research …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on 12:02 GMT

Antioxidants in Vitiligo: Experts Support Select Ingredients

As antioxidants remain a controversial tool for vitiligo therapy worldwide, experts advise sticking with evidence-based options, which include several supported by clinical studies: combined vitamin C, vitamin E, and alpha-lipoic acid (ALA); Ginkgo biloba …

Source: Medscape - Neutral
Published on Aug 14, 2026

Tavneos trial flagged for 'serious breaches' of protocol as EU regulators dissect market withdrawal decision

With the European Union formally reversing its marketing authorization for the rare disease med Tavneos last week, regulators from the bloc are laying out their concerns about the data backing the complement inhibitor in greater detail. Tavneos, which is …

Source: Fierce Pharma - Neutral
Published on Aug 14, 2026

Final Clinical Research Phase for Novel Haemolytic Uraemic Syndrome Treatment Underway in Europe

This international multicentre study will assess the efficacy and safety of INM004 in hospitalised paediatric patients with a clinical diagnosis of HUS. BUENOS AIRES, ARGENTINA, August 14, 2026 /⁨EINPresswire.com⁩/ -- A Phase 3 clinical study of …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on Aug 14, 2026

Drug Trial Data Manipulation Wiped Avacopan's EU Approval as FDA Hearing Looms

When regulators at the European Medicines Agency published the full scientific rationale behind Europe's withdrawal of avacopan on August 6, 2026, they put on record something that clinical trial sponsors and drug regulators worldwide will be studying …

Source: Tech Times - Neutral
Published on 13:06 GMT

Peptide Therapeutics Market to reach USD 83.80 Billion by 2035 at 6.7% CAGR

Peptide Therapeutics Market to Surge from USD 46.73 Billion in 2026 to USD 83.80 Billion by 2035—By GLP-1 Multi-Agonist Expansion, AI-Driven Discovery Platforms NY, CA, UNITED STATES, August 17, 2026 /⁨EINPresswire.com⁩/ -- As per Market Research …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on Aug 14, 2026

New EU Formaldehyde Limit: TOPSUN Silicone Leather Needs No Reformulation

New EU REACH: TOPSUN zero‑formaldehyde silicone leather complies with 0.062 mg/m³ requirement, no reformulation for furniture & auto interiors. SHENZHEN CITY, GUANGDONG PROVINCE, CHINA, August 14, 2026 /⁨EINPresswire.com⁩/ -- New EU rules …

Distribution channels: Automotive Industry, Building & Construction Industry ...
Published on 06:25 GMT

Top 10 Reputable Bamboo Fiber Disposable Sanitary Napkin Manufacturers in China 2026: Pure & Natural

Absorption and Protection Inspired by Nature – Exploring the Comfort Limits of Biodegradable Materials CALIFORNIA, CA, UNITED STATES, August 17, 2026 /⁨EINPresswire.com⁩/ -- QUANZHOU, China, Aug. 17, 2026Family Cares Group and its Ecolivia brand …

Distribution channels: Consumer Goods, Healthcare & Pharmaceuticals Industry ...
Published on Aug 13, 2026

MLM Medical Labs and Amprion Announce Strategic Collaboration to Expand Access to α-Synuclein Testing in Europe

MLM and Amprion partner to expand access to breakthrough α-synuclein biomarker testing for European neurodegenerative clinical trials. MöNCHENGLADBACH, NORTH RHINE-WESTPHALIA, GERMANY, August 13, 2026 /⁨EINPresswire.com⁩/ -- MLM Medical Labs (MLM), a …

Distribution channels: Business & Economy, Companies ...

07 days 14:51:06

Featured Releases

Got News to Share? · Submit · See All

Published on August 17, 2026 - 11:30 GMT

Radiopharm Theranostics To Meet with U.S. FDA to Align on Pivotal Phase 3 Trial Design for RAD 101 in Diagnosis of Brain ...

RAD 101 Phase 2b trial demonstrated 93% concordance with MRI across all evaluable lesions, meeting the Phase 2 trial's primary endpoint End-of-Phase 2 meeting with the U.S. FDA scheduled for October 1st , 2026; on track to be Phase 3 ready by year-end …

Distribution channels:
Published on August 17, 2026 - 11:00 GMT

EyePoint Announces Topline Data from LUGANO, the First of Two Pivotal Phase 3 Clinical Trials for DURAVYU™ 2.7mg in Wet ...

– DURAVYU was non-inferior to on-label aflibercept control (nominal p-value = 0.0096) in an ad hoc analysis excluding a 4% asymmetric cohort (9 of 211 patients) who experienced vision loss (≥ 15 letters) unrelated to wet AMD; primary endpoint not achieved …

Distribution channels:

Published on August 17, 2026 - 12:00 GMT

UroGen Submits NDA for UGN-103, an Investigational Treatment of Recurrent LG-IR-NMIBC

PRINCETON, N.J., Aug. 17, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the submission of a New …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on August 17, 2026 - 12:00 GMT

Rhythm Pharmaceuticals Announces Appointment of Manher (AJ) Joshi as Chief Medical Officer

BOSTON, Aug. 17, 2026 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced the …

Distribution channels:

Published on August 17, 2026 - 08:54 GMT

Five Reputable Orthodontic Supplies Manufacturers in China 2026: Advancing High-precision Dental Clinical Materials

Discover Reliable Chinese Orthodontic Suppliers Offering Quality Brackets, Archwires, Dental Materials, and Custom Solutions for Modern Clinical Applications CALIFORNIA, CA, UNITED STATES, August 17, 2026 /⁨EINPresswire.com⁩/ -- Hangzhou DTC Medical …

Distribution channels: Business & Economy, Healthcare & Pharmaceuticals Industry ...
Published on August 17, 2026 - 11:50 GMT

NovaScan Announces Nature Portfolio Publication on Rapid AI-Guided Margin Assessment in Mohs Surgery

Published in npj Biomedical Innovations, the study reports strong performance for NovaScan’s AI-guided bioimpedance platform in Mohs surgery CHICAGO, IL, UNITED STATES, August 17, 2026 /⁨EINPresswire.com⁩/ -- NovaScan, Inc., a clinical-stage …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on August 17, 2026 - 11:00 GMT

Can-Fite: Namodenoson Enhances the Anti-Cancer Effect of Chemotherapy in Pancreatic Cancer

The New Mechanistic Findings Support Can-Fite’s Ongoing Phase IIb Study Design Following Positive Phase IIa Results Ramat Gan, Israel, Aug. 17, 2026 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage …

Distribution channels: Technology ...
Published on August 17, 2026 - 11:00 GMT

NRx Pharmaceuticals (Nasdaq:NRXP) Reports Second Quarter 2026 Financial Results and Provides Corporate Update; ...

Key recent and second quarter highlights include: Completed first-cycle FDA review of the Company’s ANDA for preservative-free ketamine with no drug-related major deficiencies. The sole remaining item, a manufacturer's attestation on the vial, has been …

Distribution channels:

Got news to share? Submit it now.

Load more FDA news or search news using your own keywords. There are 934,785,683 articles in our news database.

Online News Monitoring Made Simple

Established in 1995, EIN Newsdesk helps millions of users track breaking news across thousands of trusted websites. Users may set up custom email newsletters and RSS feeds or search among thousands of preset news sections. As a member, you may also submit your own news using the EIN Presswire distribution service. Membership is free and we do not sell or lease any information about you. Press release distribution, dedicated APIs, and custom services generate the revenue that allow us to offer you free basic access.

News by Country & by Industry

Worldwide News Coverage

Track news across more than 5,000 sources by country or industry or search our real-time news index.

FDA News by Country

FDA News by U.S. State

FDA News Topics

Online News Publications

World News Report

News Alerts & News Feeds

Custom News Monitoring

News page results can be outputted as RSS or received daily by email. You may also use our NewsPlugin for WordPress.

Create Email Newsletter

Create RSS Feed

NewsPlugin for WordPress

Submit News

PR Distribution Service

Our EIN Presswire's distribution footprint reaches millions. You can upload news which is re-published through EIN Newsdesk, fed into Twitter and Facebook, and onto partner sites, Google News, Bing News, etc.

EIN Presswire

Events

World Media Directory

News Media Guide

This is a listing of the world’s TV stations, radio stations, newspapers, and blogs. Last update: 08/11/2026

World Media Directory

Food & Beverage Industry Press Releases

Got News to Share? · Submit · See All

Published on August 17, 2026 - 13:00 GMT

Yip Hong's Dim Sum Restaurant Earns 7th Consumer Choice Award for Authentic Chinese Cuisine

SASKATOON, SASKATCHEWAN, CANADA, August 17, 2026 /⁨EINPresswire.com⁩/ -- Consumer Choice Award is proud to announce that Yip Hong's Dim Sum Restaurant has been named the 2026 Consumer Choice Award winner in the Chinese Restaurants category. …

Distribution channels: Companies, Culture, Society & Lifestyle ...
Published on August 17, 2026 - 13:00 GMT

Picknic's Catering Recognized for Exceptional Catering Experiences With 2026 Consumer Choice Award

SASKATOON, SASKATCHEWAN, CANADA, August 17, 2026 /⁨EINPresswire.com⁩/ -- Consumer Choice Award is proud to announce that PickNic's Catering has been named the 2026 Consumer Choice Award winner in the Caterers category. This recognition reflects …

Distribution channels: Companies, Culture, Society & Lifestyle ...
Published on August 17, 2026 - 12:45 GMT

ComOps and ROI Solutions Partner to Turn Customer Experience Insights into Measurable Business Results

Strategic partnership connects customer and employee insights with hands-on leadership development, guest experience, marketing and operational expertise. DAVIE, FL, UNITED STATES, August 17, 2026 /⁨EINPresswire.com⁩/ -- ComOps, a strategic consulting and …

Distribution channels: Amusement, Gaming & Casino, Business & Economy ...
Published on August 17, 2026 - 12:00 GMT

Lisa’s Fifth Street Diner Earns 2026 Best of Kentucky Regional Award

BOWLING GREEN, KY, UNITED STATES, August 17, 2026 /⁨EINPresswire.com⁩/ -- Lisa’s Fifth Street Diner, a local favorite known for homemade comfort food, fresh daily meals, and a welcoming diner atmosphere, has been named a 2026 Best of Kentucky Regional …

Distribution channels: Culture, Society & Lifestyle, Food & Beverage Industry ...
Published on August 17, 2026 - 12:00 GMT

Two Synergy Logistics Leaders Named 2026 Women in Supply Chain Award Winners

Karolina "Nina" Grzebieniowska recognized as a Trailblazer, while Nicole Napoli earns Rising Stars honors CHICAGO, IL, UNITED STATES, August 17, 2026 /⁨EINPresswire.com⁩/ -- Synergy Logistics, the company behind the SnapFulfil and ORCA …

Distribution channels: Food & Beverage Industry, IT Industry ...
Published on August 17, 2026 - 12:00 GMT

Lionston Group Opens TownePlace Suites by Marriott Vaughan, SkyVu Event Centre and Golden Flame at 231 Cityview Blvd

Lionston Group officially opens TownePlace Suites by Marriott Vaughan alongside SkyVu Event Centre and Golden Flame dining in Vaughan, Ontario. VAUGHAN, ONTARIO, CANADA, August 17, 2026 /⁨EINPresswire.com⁩/ -- Lionston Group, a hospitality investment and …

Distribution channels: Business & Economy, Companies ...
Published on August 17, 2026 - 11:08 GMT

One Million Wine Events and Counting: LocalWineEvents.com Marks 26 Years in the Industry

The longest-running food & drink event platform hits a milestone that reflects a quarter-century of grassroots promotion. PHILADELPHIA, PA, UNITED STATES, August 17, 2026 /⁨EINPresswire.com⁩/ -- LocalWineEvents.com, the nation's longest- …

Distribution channels: Food & Beverage Industry ...
Published on August 17, 2026 - 10:01 GMT

Year-Round Outdoor Trading Reshapes Lighting Requirements for UK Hospitality Venues, Festive Lights Reports

An overview of how pubs, bars, restaurants and hotels are specifying commercial-grade exterior lighting to extend outdoor use beyond the summer season. CHORLEY, CHARNAROCK RICHARD, UNITED KINGDOM, August 17, 2026 /⁨EINPresswire.com⁩/ -- Festive …

Distribution channels: Culture, Society & Lifestyle, Electronics Industry ...
Published on August 17, 2026 - 10:00 GMT

Sbarro Celebrates 70 Years as the Global Leader in XL New York Pizza-by-the-Slice

'70 Years – One Iconic Slice' Honors the Brand's Legacy While Celebrating Continued Innovation and Global Growth COLUMBUS, OH, UNITED STATES, August 17, 2026 /⁨EINPresswire.com⁩/ -- For 70 years, Sbarro, LLC has been serving the …

Distribution channels: Amusement, Gaming & Casino, Consumer Goods ...
Published on August 17, 2026 - 07:49 GMT

KKday Launches Guide for USJ Halloween Horror Nights 2026

KKday releases an essential booking guide and ticket portal for USJ’s 25th Anniversary and Halloween Horror Nights 2026 to help travelers secure park entry. OSAKA, JAPAN, August 17, 2026 /⁨EINPresswire.com⁩/ -- Universal Studios Japan (USJ) is …

Distribution channels: Amusement, Gaming & Casino, Culture, Society & Lifestyle ...
Published on August 17, 2026 - 06:25 GMT

Burt Machinery Announces Availability of CE and ISO 9001 Certified Maize Milling Equipment

HANZHONG, SHAANXI, CHINA, August 17, 2026 /⁨EINPresswire.com⁩/ -- When investing in industrial grain processing, choosing the right China Reliable Maize Milling Machine Supplier requires careful consideration of facility dimensions, output goals, …

Distribution channels: Agriculture, Farming & Forestry Industry, Business & Economy ...
Published on August 17, 2026 - 06:00 GMT

Völur and Avinyó Launch Partnership to Unlock Value Capture in Pork Processing with AI

July launch will focus on cut-specific opportunities to increase value per carcass OSLO, NORWAY, August 17, 2026 /⁨EINPresswire.com⁩/ -- Völur, an AI decision-support company for meat processing, today announced a new partnership with Matadero …

Distribution channels: Agriculture, Farming & Forestry Industry, Business & Economy ...
Published on August 17, 2026 - 05:57 GMT

Suresh Naik Named Among India’s ‘25 Visionaries of India’ for Contribution to India’s $5 Trillion Economy Ambition

Harley’s Fine Baking Founder & CEO recognised on the eve of India’s 80th Independence Day for entrepreneurship, job creation and his vision CHICAGO, IL, UNITED STATES, August 17, 2026 /⁨EINPresswire.com⁩/ -- Suresh Naik, Founder and CEO of …

Distribution channels: Agriculture, Farming & Forestry Industry, Banking, Finance & Investment Industry ...
Published on August 17, 2026 - 05:55 GMT

Burt Machinery: Certified Reliable Maize Flour Milling Manufacturer

HANZHONG, SHAANXI, CHINA, August 17, 2026 /⁨EINPresswire.com⁩/ -- Integrating Certifications with Proven Milling Excellence When searching for a Reliable Maize Flour Milling Machine Manufacturer, a simple glance at a certificate is never enough …

Distribution channels: Agriculture, Farming & Forestry Industry, Business & Economy ...
Published on August 17, 2026 - 05:55 GMT

Achieving High Quality Maize Milling via Burt Machinery Design & Service

HANZHONG, SHAANXI, CHINA, August 17, 2026 /⁨EINPresswire.com⁩/ -- Establishing a successful grain processing enterprise extends far beyond simply acquiring robust machinery. It demands a holistic strategy where facility planning, mechanical …

Distribution channels: Agriculture, Farming & Forestry Industry, Business & Economy ...
Published on August 17, 2026 - 05:54 GMT

Levels Nightclub to Mark 14th Anniversary With 'Beneath the Surface' Celebration

Bangkok venue to transform into an undersea world for its 14th anniversary celebration on 27 August BANGKOK, THAILAND, August 17, 2026 /⁨EINPresswire.com⁩/ -- Levels will mark its 14th anniversary on Thursday, 27 August, with "Beneath the …

Distribution channels: Amusement, Gaming & Casino, Culture, Society & Lifestyle ...
Published on August 16, 2026 - 14:40 GMT

Never Give Up Day Is Mapping What the World Refuses to Give Up On

This August 18, a growing global map offers a new window into the dreams, causes, people and missions behind human perseverance. MIAMI BEACH, FL, UNITED STATES, August 16, 2026 /⁨EINPresswire.com⁩/ -- What people refuse to give up on is rarely …

Distribution channels: Business & Economy, Energy Industry ...
Published on August 16, 2026 - 13:00 GMT

8it’s Family Meal™ Returns with a Puerto Rican Pool Party Celebrating NYC’s Food & Beverage Industry

Top Chef Winner Danny Garcia Headlines Family Meal™ Vol. 21, While Hennessy Introduces Its New Ready to Serve Cocktails to NYC's F&B Industry BROOKLYN, NY, UNITED STATES, August 16, 2026 /⁨EINPresswire.com⁩/ -- 8it will bring its industry …

Distribution channels: Business & Economy, Culture, Society & Lifestyle ...
Published on August 15, 2026 - 20:11 GMT

Golden Waffle Turns Post-Disney Blues into Breakfast Magic for UK Families

Customers pair the UK-blended mix with Mickey-shaped waffle makers bought on Amazon to recreate treasured holiday breakfasts at home. LONDON, UNITED KINGDOM, August 15, 2026 /⁨EINPresswire.com⁩/ -- One bite, and suddenly the family kitchen feels …

Distribution channels: Consumer Goods, Food & Beverage Industry ...
Published on August 15, 2026 - 19:36 GMT

Rereleased Book, The Nutritional Handguide, Delivers 50 Essential Health Tips for Healthy Aging

The Book Also Includes Must-Read Nutritional Tips for Anyone who Drinks Alcohol or Smokes Anything GAITHERSBURG, MD, UNITED STATES, August 15, 2026 /⁨EINPresswire.com⁩/ -- FOR IMMEDIATE RELEASE August 15, 2026 …

Distribution channels: Consumer Goods, Culture, Society & Lifestyle ...