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Published on Apr 4, 2025

District Court Vacates FDA LDT Rule; What’s Next for Regulation of Lab Testing?

On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA. Judge Jordan’s decision vacates and sets aside the Food & Drug …

Source: JD Supra - California - Neutral
Published on Apr 4, 2025

FDA’s LDT Final Rule Rejected by Federal District Court in Texas

As Wilson Sonsini previously reported,1 the U.S. Food and Drug Administration (FDA) had been preparing the industry to comply with the 2024 LDT Final Rule, which phases out the FDA’s enforcement discretion policy for laboratory developed tests (LDTs) and …

Source: JD Supra - California - Neutral
Published on Apr 4, 2025

Nasal Wash Recall Updated to ‘Deadly’ Risk By FDA

The U.S. Food and Drug Administration classified a recent nasal wash recall for SinuCleanse. The recall, initiated due to microbial contamination, has been officially labeled a Class 1 recall, meaning it poses a high risk to consumers. The recall is …

Source: Prevention - Label Pending
Published on Apr 4, 2025

FDA Grants Rare Pediatric Designation to Treatment With NEO100 in Brain Cancer

The United States Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation for NEO100 (perillyl alcohol) in the treatment of pediatric-type diffuse high-grade gliomas, a life-threatening brain cancer, according to a news release …

Source: Cure Today - Neutral
Published on Apr 4, 2025

Amgen Stock Edges Higher After Uplizna Becomes First FDA-Approved Treatment For Immune-Mediated Disorder – Retail Gets ...

Uplizna is now the first FDA-approved treatment for Immunoglobulin G4-related disease, affecting an estimated 20,000 people in the United States Updated: Apr 4, 2025, 10:00 PM IST Read Full Article Shares of medicine manufacturer Amgen Inc (AMGN) are in …

Source: Asianet Newsable - Label Pending
Published on Apr 4, 2025

Congressional Committee Invites Hemp Industry Expert To Testify At Hearing On How FDA ‘Failed’ To Regulate Products

A congressional committee has scheduled a hearing for next week focused on the Food and Drug Administration (FDA), inviting a hemp industry representative to testify on how the agency “failed” to approve certain products such as CBD. The House Oversight …

Source: Marijuana Moment - Neutral
Published on Apr 4, 2025

FDA Grants Breakthrough Therapy to IDE196 in Primary Uveal Melanoma

Treatment with IDE196 (darovasertib) has been granted Breakthrough Therapy designation by the United States Food and Drug Administration (FDA) for the neoadjuvant treatment of adult patients with primary uveal melanoma for whom enucleation has been …

Source: Cure Today - Neutral
Published on Apr 4, 2025

STAT+: FDA tells drugmakers to redo studies run by a contract research firm due to data integrity issues

In a rare move, the Food and Drug Administration told an unspecified number of drug companies that studies used to support therapeutic equivalence of some of their medicines have been rejected due to false data generated by a contract research organization …

Source: STAT - Massachusetts - Neutral
Published on Apr 4, 2025

STAT+: Pharmalittle: We’re reading about FDA scrambling for workers, Pfizer CEO pay and more

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is, so far, rather modest. We plan to promenade with the official mascots, catch …

Source: STAT - Massachusetts - Neutral
Published on Apr 4, 2025

AliveDx seeks FDA approval for MosaiQ AiPlex CTDplus assay

AliveDx has submitted a 510(k) premarket notification seeking approval from the US Food and Drug Administration (FDA) for its MosaiQ AiPlex Connective Tissue Diseases (CTDplus) microarray. This multiplex assay is tailored to improve both the accuracy and …

Source: Medical Device Network - Neutral
Published on 01:03 GMT

Dramatic HHS cuts leave US ‘weaker as a nation,’ says top FDA vaccine official forced out under Kennedy

CNN — Sweeping job cuts and reorganizations taking place at the US Department of Health and Human Services under Secretary Robert F. Kennedy Jr. leave the United States “weaker as a nation,” Dr. Peter Marks told CNN on Friday. Marks, the former director …

Source: CNN - Neutral
Published on Apr 4, 2025

Baby food sold at Target recalled because of lead contamination

FRUSELVA USA of Miami, FL, is recalling 25,600 units of Good & Gather Baby Pea, Zucchini, Kale & Thyme Vegetable Puree because of elevated levels of lead. The product, distributed by Target Corporation in Minneapolis, MN, is sold nationwide at …

Source: Food Safety News - Neutral
Published on Apr 4, 2025

Consumer sparks debate over health risks of common food product: 'Question and be skeptical'

"Dangerous is subjective." by Cody JanuszkoApril 4, 2025 A Reddit user took to the r/foodscience subreddit to question the necessity and potential dangers of Red 40 dye in the food industry. The post is timely, as many major news networks in …

Source: The Cool Down - Oregon - Label Pending
Published on Apr 4, 2025

Ex-FDA Expert Dr. Yaning Wang Joins Tsingke to Drive Small Nucleic Acid Drug Innovation

BEIJING, April 4, 2025 /PRNewswire/ — Recently, Beijing Tsingke Biotech Co., Ltd. officially announced the appointment of Dr. Yaning Wang, a former senior expert at the FDA, as the company’s Chief Scientific Advisor in the field of small nucleic …

Source: The Laotian Times - Uncategorized
Published on 02:47 GMT

Behind Durvalumab's FDA Approval: NIAGARA Trial in MIBC

Matt Galsky, MD, medical oncologist at the Icahn School of Medicine at Mount Sinai, associate director for translational research for the Tisch Cancer Institute, discusses the phase 3 NIAGARA trial (NCT03732677) that led to the recent FDA approval of …

Source: Targeted Oncology - Label Pending
Published on 02:56 GMT

FDA recalls mislabeled coffee sold in Indiana, 14 other states

INDIANAPOLIS (WISH) — Here is a look at Friday’s business headlines with Jeff Vaughn, where he discusses stocks plunging as markets adjust to Trump’s tariff blitz. Trump tariffs cause stocks to lose trillions in value The “Magnificent Seven” stocks …

Source: WISH 8 - Indiana - Neutral
Published on Apr 4, 2025

FDA staff cuts could disrupt drug reviews, putting agency's critical funding programs at risk: reports

As reports surface detailing the extent of Robert F. Kennedy Jr.’s layoffs at the Department of Health and Human Services, FDA officials are sounding the alarm about their ability to review applications for new drugs moving forward. The 3,500 job cuts …

Source: Fierce Pharma - Neutral
Published on Apr 4, 2025

N-Nitrosamine Impurities and FDA’s Recommendations for Acceptable Intake Limits

Nitrosamines occurring in pharmaceuticals became a developing problem in 2018, and regulatory agencies have been working with pharmaceutical companies since to mitigate the risk of these cancer-causing chemicals in drug products (1). In January 2025, FDA …

Source: Pharmaceutical Technology - Neutral
Published on Apr 4, 2025

FDA destroys massive haul of opioids seized in joint operation

The Food and Drugs Authority (FDA) has begun the safe disposal of a significant quantity of unregistered, high-strength opioid drugs that were illegally imported into Ghana. The destruction exercise follows a court order secured by the FDA after the drugs …

Source: Joy FM - Label Pending

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Published on April 4, 2025 - 15:48 GMT

Bispecific Trispecific Antibodies Market Size FDA Approval Clinical Trials Drug Sales Insight 2030

Delhi, April 04, 2025 (GLOBE NEWSWIRE) -- Over the last two decades, immunotherapy has transformed treatment strategies across various medical fields. The effectiveness of monoclonal antibodies in specifically targeting certain antigens has led to the …

Distribution channels: Banking, Finance & Investment Industry, Environment ...
Published on April 5, 2025 - 02:33 GMT

BeastForce Under Review: Introducing the Blood Flow Reset Formula for Men

Denver, April 04, 2025 (GLOBE NEWSWIRE) -- Many men face challenges related to energy levels, stamina, and confidence, which can significantly impact their quality of life. Enter BeastForce, a revolutionary male enhancement supplement designed to tackle …

Distribution channels: Consumer Goods, Media, Advertising & PR ...

Published on April 5, 2025 - 02:36 GMT

Genuine Purity Liposomal NMN: Best NMN Supplement Brand by Leading Edge Health

Las Vegas, April 04, 2025 (GLOBE NEWSWIRE) -- In the world of anti-aging and cellular health, one NAD+ booster has risen above all others as the premier solution for longevity, energy, and age-defying wellness: GenuinePurity™ Liposomal NMN, developed and …

Distribution channels: Consumer Goods, Media, Advertising & PR ...
Published on April 5, 2025 - 00:22 GMT

Arialief Reviews Reveal Natural Neuropathy Pain Relief Claims: Everything to Know

Denver, April 04, 2025 (GLOBE NEWSWIRE) -- Neuropathy, a condition affecting millions globally, manifests as nerve pain, tingling, and numbness, significantly impacting the quality of life. Traditional treatments often yield temporary relief or come with …

Distribution channels: Consumer Goods, Media, Advertising & PR ...

Published on April 4, 2025 - 23:19 GMT

LungExpand Pro: Review the Unique Lung Clearing Breathing Solution for Healthy Respiratory System

Akron, April 04, 2025 (GLOBE NEWSWIRE) -- In today’s fast-paced world, respiratory health has become a growing concern for many individuals. With increasing pollution levels, lifestyle changes, and stress factors, the need for effective respiratory support …

Distribution channels: Consumer Goods, Media, Advertising & PR ...
Published on April 4, 2025 - 14:19 GMT

Cardiac Safety Services Market to Reach USD 510.7 Billion by 2033, Driven by Rising Cardiovascular Disease Cases

The global Cardiac Safety Services Market is poised for significant growth, with market size expected to increase from an estimated USD 310.1 billion in 2024 VANCOUVER, BRITISH COLUMBIA, CANADA, April 4, 2025 /⁨EINPresswire.com⁩/ -- The Global …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on April 4, 2025 - 16:16 GMT

The Silhouette Clinic and Dr. Halim Charbel now offering Spatz Balloon Procedure

The Silhouette Clinic & Dr. Halim Charbel now offer the FDA-approved Spatz3 adjustable gastric balloon for non-surgical, personalized weight loss and wellness. GERMANTOWN, MD, UNITED STATES, April 4, 2025 /⁨EINPresswire.com⁩/ -- The Silhouette …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on April 4, 2025 - 10:00 GMT

ACC.25 Panel of Experts Awards VisCardia Top Honors for Innovation in MedTech

VisCardia wins ACC.25 Innovation Pitch Competition Award PORTLAND, OR, UNITED STATES, April 4, 2025 /⁨EINPresswire.com⁩/ -- VisCardia, Inc. is honored to announce that our team has won the judge’s vote during the Future Hub ACC.25 Innovation Pitch …

Distribution channels: Banking, Finance & Investment Industry, Business & Economy ...

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Published on April 4, 2025 - 22:52 GMT

OneCert Ushers in a Dynamic New Chapter with Karlin Warner as CEO

OneCert, Inc., a leading force in organic certification, is thrilled to announce a significant transition in leadership. LINCOLN, NE, UNITED STATES, April 4, 2025 /⁨EINPresswire.com⁩/ -- OneCert, Inc., a leading force in organic certification, is …

Distribution channels: Agriculture, Farming & Forestry Industry, Business & Economy ...
Published on April 4, 2025 - 22:32 GMT

Jans Launches Sparkling Prebiotic Drinks: Fruity, Fizzy, and Made for Every Moment

Jans Enterprises introduces its latest lineup of Sparkling Prebiotic Drinks—low-sugar, non-GMO beverages available in four fruity, refreshing flavors. LOS ANGELES, CA, UNITED STATES, April 4, 2025 /⁨EINPresswire.com⁩/ -- Jans Enterprises Corp, a …

Distribution channels: Food & Beverage Industry, Retail ...
Published on April 4, 2025 - 21:07 GMT

Whataburger Celebrates 75th Anniversary with Bold 'Orange Out' Airport Activation by FPO Marketing

Hometown Brand Welcomes Fans at San Antonio International Airport During the Nation’s Biggest Men's College Basketball Weekend SAN ANTONIO, TX, UNITED STATES, April 4, 2025 /⁨EINPresswire.com⁩/ -- As San Antonio hosts the nation’s biggest weekend in …

Distribution channels: Aviation & Aerospace Industry, Consumer Goods ...
Published on April 4, 2025 - 20:00 GMT

À la découverte du Saint Graal : le trésor caché de Valence au cœur de l’Europe

Conférence à Léognan sur le Saint Calice de Valence, source du mythe du Graal, et son itinéraire culturel européen. Réservation obligatoire. LéOGNAN (BORDEAUX), ZARAGOZA, FRANCE, April 4, 2025 /⁨EINPresswire.com⁩/ -- Le samedi 5 avril 2025 à 10h30 …

Distribution channels: Agriculture, Farming & Forestry Industry, Conferences & Trade Fairs ...
Published on April 4, 2025 - 17:56 GMT

The Nerds to Headline Fundraiser for Westfield American Legion Housing Project

The Nerds, along with emerging talents such as Kobi Reese and Better Late, will be performing at third annual 'Rock the Foundation' fundraiser on May 3, 2025. WESTFIELD, NJ, UNITED STATES, April 4, 2025 /⁨EINPresswire.com⁩/ -- The Nerds, New …

Distribution channels: Food & Beverage Industry, Human Rights ...
Published on April 4, 2025 - 17:55 GMT

Juan Valdez continues its expansion plan in the United States

Juan Valdez plans 16 stores in Miami and Orlando by 2025, offering premium Colombian coffee, a unique experience, and a diverse product lineup. MIAMI, ORLANDO, FL, UNITED STATES, April 4, 2025 /⁨EINPresswire.com⁩/ -- According to its positioning …

Distribution channels: Business & Economy, Culture, Society & Lifestyle ...
Published on April 4, 2025 - 17:25 GMT

International Food & Beverage Association, Hospitality Alliance Singapore, and IEG Asia form Historic Partnership

To Drive Industry Innovation and Elevate the F&B and Ho.Re.Ca. Industry at SIGEP Asia & Restaurant Asia 2025 SINGAPORE, SINGAPORE, April 5, 2025 /⁨EINPresswire.com⁩/ -- The International Food & Beverage Association (IFBA), Hospitality …

Distribution channels: Business & Economy, Conferences & Trade Fairs ...
Published on April 4, 2025 - 17:13 GMT

ACHS Appoints Dr. Patricia Kaufman as Dean of Integrative Health and Nutrition

ACHS promotes Dr. Patricia Kaufman to Dean of Integrative Health & Nutrition, highlighting her impact on functional nutrition, research, and student success. PORTLAND, OR, UNITED STATES, April 4, 2025 /⁨EINPresswire.com⁩/ -- The American …

Distribution channels: Beauty & Hair Care, Consumer Goods ...
Published on April 4, 2025 - 15:58 GMT

Bringing Tulum to Bangkok: The Vision Behind the City’s Most Stylish New Rooftop

BANGKOK, THAILAND, April 4, 2025 /⁨EINPresswire.com⁩/ -- Rising above the city’s vibrant streets, Tulum Sky Bar Bangkok is more than just a nightlife venue—it is a design-driven rooftop sanctuary that fuses Mexican-inspired elegance with Bangkok’s urban …

Distribution channels: Culture, Society & Lifestyle, Food & Beverage Industry ...
Published on April 4, 2025 - 15:06 GMT

Alarming Levels of Heavy Metals Found in 95% of Commercial Baby Foods, New Report Reveals

Groundbreaking report by health and nutrition authority FoodNourish.net exposes regulatory failures allowing toxic contaminants in foods marketed for infants SEATTLE, WA, UNITED STATES, April 4, 2025 /⁨EINPresswire.com⁩/ -- A groundbreaking …

Distribution channels: Consumer Goods, Environment ...
Published on April 4, 2025 - 14:56 GMT

Sea Moss Gummies Market anticipated to reach US$554.855 million by 2030 at a CAGR of 5.74%

The sea moss gummies market is anticipated to grow at a CAGR of 5.74% from US$419.789 million in 2025 to US$554.855 million by 2030. NEW YORK, NY, UNITED STATES, April 4, 2025 /⁨EINPresswire.com⁩/ -- According to a new study published by Knowledge …

Distribution channels: Food & Beverage Industry ...
Published on April 4, 2025 - 14:49 GMT

Frozen Food Leader Strengthens MRO Data Governance with Verdantis Ahead of SAP S/4HANA Migration

PRINCETON, NJ, UNITED STATES, April 4, 2025 /⁨EINPresswire.com⁩/ -- Verdantis, the AI Super-Agent for Master Data, has announced a new partnership with a leading U.S.-based frozen food manufacturer. As a trusted name in consumer and food service …

Distribution channels: Chemical Industry, Consumer Goods ...
Published on April 4, 2025 - 14:38 GMT

BuyRexroth.com Increases Offerings, Adds Complementary Products

It has added components from Anchor Fluid Power, Emerson Aventics, CEJN, DMIC, Flextral, Hedland, Hengst, NoShok, and Thermal Transfer. CINCINNATI, OH, UNITED STATES, April 4, 2025 /⁨EINPresswire.com⁩/ -- Introduced in 2020, BuyRexroth.com now …

Distribution channels: Agriculture, Farming & Forestry Industry, Automotive Industry ...
Published on April 4, 2025 - 14:38 GMT

Starkel Capital Invests in Apothecary Farms, a Leading Multi-State Cannabis Operator Poised for Accelerated Growth

Starkel Capital invests in Apothecary Farms, a vertically-integrated multi-state cannabis operator in the Midwest OMAHA, NE, UNITED STATES, April 4, 2025 /⁨EINPresswire.com⁩/ -- Starkel Capital Management, Inc. ("SCM"), an investment …

Distribution channels: Agriculture, Farming & Forestry Industry, Consumer Goods ...
Published on April 4, 2025 - 14:29 GMT

CATENA NAMED THE NUMBER ONE WORLD’S MOST ADMIRED WINE BRAND 2025 BY DRINKS INTERNATIONAL MAGAZINE

The Catena family celebrates this recognition in the 15th edition of the Drinks International ranking MENDOZA, ARGENTINA, April 4, 2025 /⁨EINPresswire.com⁩/ -- On March 27th, Drinks International announced that Catena was voted The World’s Most …

Distribution channels: Food & Beverage Industry ...
Published on April 4, 2025 - 13:28 GMT

Beef Tallow Market projected to achieve a CAGR of 4.72% to reach US$4.809 billion by 2030

The beef tallow market is anticipated to grow at a CAGR of 4.72% from US$3.818 billion in 2025 to US$4.809 billion by 2030. NEW YORK, NY, UNITED STATES, April 4, 2025 /⁨EINPresswire.com⁩/ -- According to a new study published by Knowledge Sourcing …

Distribution channels: Food & Beverage Industry ...
Published on April 4, 2025 - 09:00 GMT

Bertolli Reinvents Olive Oil for a New Era, Bringing Mediterranean 'Good Living' to American Kitchens

New CBS documentary showcases how the world’s leading olive oil brand is pioneering sustainability and innovation. DALLAS, TX, UNITED STATES, April 4, 2025 /⁨EINPresswire.com⁩/ -- As the very first branded olive oil imported to the United States …

Distribution channels: Consumer Goods, Culture, Society & Lifestyle ...
Published on April 4, 2025 - 09:00 GMT

Upskilling in the digital age: Axonify’s innovative training drives peak frontline performance

New CBS series debuts impact for leading global brands Kroger and Marriott International WATERLOO , ONTARIO , CANADA, April 4, 2025 /⁨EINPresswire.com⁩/ -- Today, Axonify, a global leader in frontline learning and enablement, announces its …

Distribution channels: Banking, Finance & Investment Industry, Food & Beverage Industry ...
Published on April 4, 2025 - 20:30 GMT

Beyond Oil Announces Distribution Agreement in the Netherlands with Mandarin Food Products

VANCOUVER, BC and KIBBUTZ YIFAT, Israel, April 04, 2025 (GLOBE NEWSWIRE) -- Beyond Oil Ltd. (CSE: BOIL) (OTCQB: BEOLF) (Frankfurt: UH9) ("Beyond Oil" or the "Company"), a food-tech innovation company dedicated to reducing health risks …

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Published on April 4, 2025 - 20:23 GMT

Far Niente Steps Up to the Plate as Proud Partner of the San Francisco Giants

Oakville, CA, April 04, 2025 (GLOBE NEWSWIRE) -- Far Niente Wine Estates, one of Napa Valley’s most venerated wine houses, is delighted to announce it will bring its portfolio to Oracle Park as a proud partner of the San Francisco Giants. Beginning this …

Distribution channels: Companies, Food & Beverage Industry ...