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

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

Japan FDA News ••• Topics • Japan Media Directory

Japan FDA Newswire

Get by Email • RSS

Published on 10:35 GMT

FDA approves Selarsdi injection as interchangeable with Stelara

Teva Pharmaceuticals and Alvotech have announced that the US Food and Drug Administration (FDA) has approved the Selarsdi (ustekinumab-aekn) injection as interchangeable with reference biologic Stelara (ustekinumab). As of 30 April, Selarsdi is now …

Source: Pharmaceutical Technology - Neutral
Published on May 5, 2025

FDA approves Genus’ gene-edited PRRS-resistant pigs

Britain-based Genus plc has received U.S. Food and Drug Administration approval for its gene-edited PRRS-resistant pig, marking a major milestone in the company’s push toward commercialization in the U.S. pork market. The approval clears the way for the …

Source: AGDAILY - Michigan - Pending
Published on May 5, 2025

Capricor Therapeutics Stock Tumbles After FDA Confirms Intent To Hold Advisory Committee Meet For Deramiocel Approval: ...

The U.S. FDA stated that its review committee has identified no significant deficiencies and is on track to make a decision on the application by its deadline of the end of August. Capricor Therapeutics (CAPR) announced on Monday that it has completed a …

Source: Asianet Newsable - Pending
Published on May 5, 2025

Taiwan to open doors to imports of all Japanese beef products

Taipei, May 5 (CNA) Taiwan is planning to allow the import of Japanese beef products of all ages but has yet to set a timeline, said Taiwan Food and Drug Administration (TFDA) Director-General Chiang Chih-kang (姜至剛) on Monday. The TFDA first proposed the …

Source: Focus Taiwan - Neutral
Published on May 5, 2025

Intuitive's da Vinci Single-Port Surgical Robot Earns Expanded FDA OK

Intuitive said the FDA cleared the da Vinci Single Port (SP) surgical system for transanal local excision/resection, a form of minimally invasive surgery performed through a natural orifice to avoid abdominal surgical incisions for select procedures. …

Source: Design and Development Today - Wisconsin - Pending
Published on May 5, 2025

Capricor Therapeutics Announces Completion of Mid-Cycle Review Meeting with FDA on Deramiocel for the Treatment of ...

-Company remains on track for PDUFA target action date of August 31, 2025- -Advisory committee meeting to be held in advance of target action date- SAN DIEGO, May 05, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company …

Distribution channels: Technology ...
Published on May 5, 2025

Teva and Alvotech Announce FDA Approval of Interchangeability for SELARSDI™ (ustekinumab-aekn) with Stelara® (...

The U.S. FDA has approved SELARSDI™ (ustekinumab-aekn) as interchangeable with the reference biologic Stelara® (ustekinumab) in all presentations matching the reference product, effective as of April 30, 2025 SELARSDI is approved for all indications …

Distribution channels: Healthcare & Pharmaceuticals Industry, Media, Advertising & PR ...
Published on May 5, 2025

Teva and Alvotech Announce FDA Approval of Interchangeability for SELARSDI™ (ustekinumab-aekn) with Stelara® (...

The U.S. FDA has approved SELARSDI™ (ustekinumab-aekn) as interchangeable with the reference biologic Stelara® (ustekinumab) in all presentations matching the reference product, effective as of April 30, 2025 SELARSDI is approved for all indications …

Distribution channels: Companies, Healthcare & Pharmaceuticals Industry ...
Published on 09:12 GMT

Nagano Lean Body Tonic Reviews (WARNING) Shocking Consumer Reports on Ingredients, Side Effects, And Benefits!

Explore the benefits, side effects, and user feedback on Nagano Tonic. Learn how this natural weight loss formula boosts metabolism, supports energy and promotes healthy fat burning with its clinically-backed ingredients. NEW YORK, May 06, 2025 (GLOBE …

Distribution channels: Banking, Finance & Investment Industry, Media, Advertising & PR ...
Published on 12:01 GMT

Ardelyx Presents Data Supporting IBSRELA® (tenapanor) at Digestive Disease Week 2025 Conference

WALTHAM, Mass., May 06, 2025 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today …

Distribution channels: Culture, Society & Lifestyle, Healthcare & Pharmaceuticals Industry ...
Published on 08:54 GMT

Ractopamine detected in more Australian pork, but within legal limits

Taipei, May 6 (CNA) Traces of the controversial veterinary drug ractopamine have been detected in two batches of frozen pork knuckles imported from Australia, the Taiwan Food and Drug Administration (TFDA) said Tuesday. The shipments, totaling 47.25 metric …

Source: Focus Taiwan - Neutral
Published on 01:53 GMT

Longevity Activator Under Review: Best Anti-Aging Supplement for Healthy Cellular Longevity

New York, May 05, 2025 (GLOBE NEWSWIRE) -- In This Article, You’ll Discover: What Longevity Activator is and how it may support healthy aging Why cellular health, telomeres, and mitochondrial function are crucial to aging How ingredients like resveratrol, …

Distribution channels: Consumer Goods, Media, Advertising & PR ...
Published on May 2, 2025

Genmab to Submit Supplemental Biologics License Application (sBLA) to U.S. Food and Drug Administration for Epcoritamab ...

Company Announcement Decision to submit based on a positive overall response rate (ORR) (p-value < 0.0001), one of the dual primary endpoints in the Phase 3 EPCORE® FL-1 trial Full results from the trial will be submitted for presentation at an upcoming …

Distribution channels: Technology ...
Published on May 3, 2025

In selling Maryland, Wes Moore offers Japan, Korea a Trump alternative

SEOUL — For the better part of an hour, the governor’s delegation and Japanese business leaders had pitched Maryland to a room full of investors, entrepreneurs and executives in a Tokyo highrise without the president coming up. Then the questions started. …

Source: Baltimore Banner - Maryland - Pending
Published on May 3, 2025

Fop HHS advisor warns of ‘interconnectivity’ between US food supply and childhood disease

The senior advisor for the Trump administration’s Make America Healthy Again (MAHA) agenda minces no words when it comes to challenging the status quo operations of the Big Pharma and Big Food empires that, up until now, have thrived without exposure. …

Source: CatholicVote - Wisconsin - Right-wing
Published on May 2, 2025

Intuitive wins new FDA nod for single port robot; Resmed buys diagnostic facility

Intuitive Surgical received Food and Drug Administration clearance for its da Vinci Single Port surgical system for procedures performed through the anus. The clearance covers the use of the system for transanal local excision/resection, enabling …

Source: MedTech Dive - Neutral
Published on May 2, 2025

Gene-Edited Pigs Gain FDA Approval

The NPA has welcomed a landmark decision by the US Food and Drug Administration (FDA) to approve the gene edit used in its PIC’s PRRS-resistant pig, determining that the technology is safe and effective. After a long regulatory process to reach this point, …

Source: Northern Ag Network - Pending
Published on May 5, 2025

Urgent choking hazard warning for breakfast favorite that may contain pieces of plastic

A massive recall has been issued for thousands of frozen hash browns after plastic pieces were found in the breakfast favorite. The US Food and Drug Administration said that 34,801 cases of Lamb Weston oval-shaped frozen hash browns have been affected by …

Source: Daily Mail - Right-wing
Published on May 2, 2025

FDA approves sale of gene-edited pigs in the US

FDA approves commercial sale of gene-edited pigs in the US, offering a breakthrough in disease-resistant livestock following UK breakthrough. In a major breakthrough for global food and farming, the US Food and Drug Administration (FDA) has approved the …

Source: New Food Magazine - Neutral

06 days 14:37:26

Featured Releases

Got News to Share? · Submit · See All

Published on May 6, 2025 - 12:00 GMT

Opus Genetics Granted FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for OPGx-LCA5 Gene Therapy Candidate

RESEARCH TRIANGLE PARK, N.C., May 06, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage ophthalmic biotechnology company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and other ophthalmic …

Distribution channels: Healthcare & Pharmaceuticals Industry, Technology ...
Published on May 6, 2025 - 12:00 GMT

SkyDance Vascular Gains FDA Clearance for Innovative Osprey Midline Closed IV Catheter System

New Extended Dwell Catheter System Poised to Advance PIVC Patient Safety and Outcomes DELRAY BEACH, FL, UNITED STATES, May 6, 2025 /⁨EINPresswire.com⁩/ -- SkyDance Vascular, Inc. (SkyDance) today announced it has received 510(k) clearance from the …

Distribution channels: Business & Economy, Healthcare & Pharmaceuticals Industry ...

Published on May 6, 2025 - 09:00 GMT

Italfarmaco Announces U.S. FDA Grants Fast Track Designation to Givinostat in Treatment of Polycythemia Vera

MILAN, Italy, May 6, 2025 – Italfarmaco S.p.A. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to givinostat for the treatment of patients with polycythemia vera (PV), a rare haematologic cancer, for …

Distribution channels: Healthcare & Pharmaceuticals Industry, Media, Advertising & PR ...
Published on May 5, 2025 - 18:39 GMT

Filing a Claim for Injuries Caused by Contaminated Food in Louisiana

OPELOUSAS, LA, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- Contaminated food continues to pose a serious risk to public health. Incidents involving foodborne illnesses often result in medical complications, hospitalization, or long-term …

Distribution channels: Culture, Society & Lifestyle, Food & Beverage Industry ...

Published on May 6, 2025 - 12:18 GMT

Windtree Announces Istaroxime Exclusivity and Intellectual Property Potential Strategy for US

WARRINGTON, Pa., May 06, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on becoming a revenue generating company and advancing early and late-stage innovative therapies …

Distribution channels: Healthcare & Pharmaceuticals Industry, Technology ...
Published on May 6, 2025 - 12:00 GMT

Krystal Biotech Announces First Quarter 2025 Financial and Operating Results

VYJUVEK approved in Europe for the treatment of DEB patients from birth $88.2 million in 1Q VYJUVEK revenue and $429.4 million since launch in Q3 2023 Second ophthalmic program in clinic - KB801 for the treatment of neurotrophic keratitis Upcoming clinical …

Distribution channels: Business & Economy, Technology ...
Published on May 6, 2025 - 12:00 GMT

Corbus Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides a Corporate Update

Dose optimization and RP2D determination on schedule for completion in Q4 2025 for the Nectin-4 ADC CRB-701 in HNSCC, cervical and mUC tumors SAD/MAD study on schedule for completion in Q3 2025 for the anti-obesity CB1 inverse agonist CRB-913 Dose …

Distribution channels: Business & Economy, Technology ...
Published on May 6, 2025 - 12:30 GMT

Achieve Life Sciences to Announce First Quarter 2025 Financial Results and Host Conference Call and Webcast on May 13, ...

SEATTLE and VANCOUVER, British Columbia, May 06, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV) a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of …

Distribution channels: Culture, Society & Lifestyle, Healthcare & Pharmaceuticals Industry ...

Got news to share? Submit it now.

Load more FDA news or search news using your own keywords. There are 809,946,358 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: 04/18/2025

World Media Directory

Food & Beverage Industry Press Releases

Got News to Share? · Submit · See All

Published on May 6, 2025 - 13:03 GMT

The Salvation Army of Greater New York Serves Over 10.7 Million Meals in 2024

Relentlessly Fighting Hunger Across the Five Boroughs and Beyond NEW YORK, NY, UNITED STATES, May 6, 2025 /⁨EINPresswire.com⁩/ -- The Salvation Army of Greater New York announced today that the organization served more than 10.7 million meals in …

Distribution channels: Business & Economy, Culture, Society & Lifestyle ...
Published on May 6, 2025 - 12:00 GMT

The Pickled Beet Celebrates Twenty Years in Business

The Award-Winning Culinary Company Has Provided Two Decades of Purposeful Cooking and Heartfelt Service in South Florida MIAMI, FL, UNITED STATES, May 6, 2025 /⁨EINPresswire.com⁩/ -- The Pickled Beet, South Florida’s award-winning gourmet chef and …

Distribution channels: Business & Economy, Companies ...
Published on May 6, 2025 - 11:30 GMT

Nut Butters Market Set for Remarkable Growth: A Comprehensive Overview and Future Outlook 2035 | FMI

Nut Butters Market is experiencing significant growth due to rising demand for healthy, plant-based products and increasing consumer awareness of their benefit NEWARK, DE, UNITED STATES, May 6, 2025 /⁨EINPresswire.com⁩/ -- The global nut butters …

Distribution channels: Food & Beverage Industry ...
Published on May 6, 2025 - 09:00 GMT

Takeout Dinner Market to Reach USD 539,217.9 Million by 2035, Driven by Convenience and Digital Innovations | FMI

The Takeout Dinner Market is expanding steadily, driven by changing lifestyles, rising demand for convenience, and evolving consumer eating habits. NEWARK, DE, UNITED STATES, May 6, 2025 /⁨EINPresswire.com⁩/ -- The global Takeout Dinner Market is …

Distribution channels: Food & Beverage Industry ...
Published on May 6, 2025 - 08:08 GMT

Hyperlocal Grocery Delivery Market to Reach USD 111.3 Billion by 2035, Growing at a CAGR of 8.8% | FMI

Hyperlocal grocery delivery market is growing rapidly, driven by consumer demand for convenience, quick service, and digital ordering platforms. NEWARK, DE, UNITED STATES, May 6, 2025 /⁨EINPresswire.com⁩/ -- The Hyperlocal Grocery Delivery …

Distribution channels: Food & Beverage Industry ...
Published on May 6, 2025 - 07:45 GMT

Olympia’s Small Businesses Face Tough Times—Digital Solutions Hope

In an Era of Rising Costs, Olympia Small Businesses Find a New Ally: Websites That Work Like Employees OLYMPIA, WA, UNITED STATES, May 6, 2025 /⁨EINPresswire.com⁩/ -- In a time when small businesses are facing rising costs, limited staff, and …

Distribution channels: Business & Economy, Companies ...
Published on May 6, 2025 - 05:12 GMT

La Original Banda El Limón celebra el 5 de mayo con 'Enamorado', su nuevo éxito que ya conquista las redes

Ya Disponible en todas las plataformas digitales En radio: 5 de mayo en Estados Unidos / 7 de mayo en México LOS ANGELES, CA, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- En el marco de las celebraciones del 5 de mayo, La Original Banda El …

Distribution channels: Culture, Society & Lifestyle, Food & Beverage Industry ...
Published on May 6, 2025 - 12:42 GMT

Cheez-It™ Frozen Pizza: The Ultimate Snack Collaboration Hits Shelves

Milwaukee, Wisconsin, May 06, 2025 (GLOBE NEWSWIRE) -- Cheez-It™ Frozen Pizza is the unexpected collaboration snack fans didn’t know they needed. Palermo Villa, Inc., a frozen pizza giant, and Cheez-It®, a leading snack brand, have partnered to bring Cheez …

Distribution channels: Companies, Culture, Society & Lifestyle ...
Published on May 6, 2025 - 12:08 GMT

Hardee’s Introduces New Menu Offerings to Kick Off Warmer Weather

ROCKY MOUNT, N.C., May 06, 2025 (GLOBE NEWSWIRE) -- Hardee’s, famous for its golden-brown Made from Scratch™ biscuits, fresh Hand-Breaded Chicken Tenders™ and more, is getting a head start on summer with several exciting new offerings, as well as bringing …

Distribution channels: Food & Beverage Industry, Media, Advertising & PR ...
Published on May 6, 2025 - 00:00 GMT

NEXCOM Enhances Smart Retail Operations with the Versatile Neu-X104

AI-Powered Self-Service Kiosks Improve Contactless Customer Experiences with Faster Data Transfer Speeds FREMONT, CA, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- NEXCOM, a leading global supplier of intelligent retail solutions, announced …

Distribution channels: Automotive Industry, Food & Beverage Industry ...
Published on May 6, 2025 - 12:00 GMT

Portillo’s Inc. Announces First Quarter Financial Results

CHICAGO, May 06, 2025 (GLOBE NEWSWIRE) -- Portillo’s Inc. (“Portillo’s” or the “Company”) (NASDAQ: PTLO), the restaurant concept known for its menu of Chicago-style favorites, today reported financial results for the first quarter ended March 30, 2025. …

Distribution channels: Business & Economy, Culture, Society & Lifestyle ...
Published on May 6, 2025 - 11:00 GMT

J & J Snack Foods Reports Fiscal 2025 Second Quarter Results

MOUNT LAUREL, N.J., May 06, 2025 (GLOBE NEWSWIRE) -- J & J Snack Foods Corp. (NASDAQ: JJSF) (the “Company”) today reported financial results for the second quarter ended March 29, 2025. Second Quarter Actuals $ vs. LY % vs. LY Net Sales $356.1M ($3 …

Distribution channels: Business & Economy, Food & Beverage Industry ...
Published on May 6, 2025 - 10:55 GMT

Slimjaro Under Review : Inspecting the Results of Slim jaro ingredients, Benefits, Pros and Cons! Pink Salt Trick Recipe ...

Kansas City MO, May 06, 2025 (GLOBE NEWSWIRE) -- Let's face it - we're drowning in weight loss products that promise the world but leave us high and dry. But there's a new kid on the block called Slimjaro, and it's got doctors, researchers, …

Distribution channels: Food & Beverage Industry, Healthcare & Pharmaceuticals Industry ...
Published on May 5, 2025 - 22:08 GMT

La Concha Key West Chef Wins Top Prize in the Fourth Annual Cuban Sandwich Throwdown

KEY WEST, FL, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- La Concha Key West, Autograph Collection, the ultimate escape from the ordinary with a warm and vibrant tropical Key West experience, is thrilled to announce its Executive Chef, Juan Cuadra, …

Distribution channels: Culture, Society & Lifestyle, Food & Beverage Industry ...
Published on May 6, 2025 - 10:05 GMT

Ingredion Incorporated Reports Strong First Quarter Results and Improves Full-Year Outlook

First quarter 2025 reported and adjusted* operating income increased 30% and 26% compared to prior year First quarter 2025 reported and adjusted EPS were $3.00 and $2.97, compared with $3.23 and $2.08 in the first quarter 2024 Improving guidance for full- …

Distribution channels: Business & Economy, Culture, Society & Lifestyle ...
Published on May 6, 2025 - 10:00 GMT

BIGELOW TEA CELEBRATES 80 YEARS OF "CONSTANT COMMENT"®

Fairfield, Connecticut, May 06, 2025 (GLOBE NEWSWIRE) -- Bigelow Tea celebrates 80 years of "Constant Comment"®, the iconic blend that launched America's first specialty tea company in 1945. As a third-generation, family and woman-owned …

Distribution channels: Culture, Society & Lifestyle, Food & Beverage Industry ...
Published on May 5, 2025 - 21:18 GMT

Volunteer Botanicals Launches Service to Help Brewers, Distillers Expand Product Line, Generate New Revenue

‘Beverage Accelerator Program’ lets beverage makers go from idea to distribution in 90 days utilizing Volunteer Botanicals’ proprietary functional ingredients MURFREESBORO, TN, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- Volunteer Botanicals, …

Distribution channels: Food & Beverage Industry ...
Published on May 5, 2025 - 20:00 GMT

BIATCH Tequila Celebrates Milestone Launch Year with Major Cinco de Mayo Push

Distinctive Tequila for a Distinctive Celebration NEW YORK, NY, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- BIATCH Tequila, the boundary-pushing 100% woman owned brand that combines traditional Mexican craftsmanship with bold modern flair, …

Distribution channels: Culture, Society & Lifestyle, Food & Beverage Industry ...
Published on May 5, 2025 - 18:46 GMT

Inside the Fire Code: What NYC Restaurants Need to Know About Hood Cleaning

BROOKLYN, NY, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- New York City restaurants are facing a hidden threat that often goes unnoticed: neglected kitchen exhaust hoods. FDNY data show nearly 200 restaurant fires occur in NYC each year, …

Distribution channels: Business & Economy, Emergency Services ...
Published on May 5, 2025 - 18:39 GMT

Filing a Claim for Injuries Caused by Contaminated Food in Louisiana

OPELOUSAS, LA, UNITED STATES, May 5, 2025 /⁨EINPresswire.com⁩/ -- Contaminated food continues to pose a serious risk to public health. Incidents involving foodborne illnesses often result in medical complications, hospitalization, or long-term …

Distribution channels: Culture, Society & Lifestyle, Food & Beverage Industry ...