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Published on Jun 30, 2025

FDA hits Unicycive with manufacturing-related complete response letter, delaying hopes for kidney disease prospect

Unicycive Therapeutics has hit a bump on the road in its mission to bring its hyperphosphatemia treatment candidate to patients with chronic kidney disease (CKD) who are on dialysis. The FDA issued the company a complete response letter (CRL), citing …

Source: Fierce Pharma - Neutral
Published on Jun 30, 2025

Aldeyra Therapeutics gets US FDA’s special protocol assessment agreement letter for its drug candidate, ADX-2191 to ...

Aldeyra Therapeutics, Inc, a biotechnology company devoted to discovering innovative therapies designed to treat immune-mediated and metabolic diseases, announced the receipt of a special protocol assessment agreement letter from the US Food and Drug …

Source: Pharmabiz.com - Neutral
Published on Jun 30, 2025

FDA Approves Emapalumab-Lzsg as First-Ever Treatment for Macrophage Activation Syndrome in Still Disease

The FDA has announced regulatory approval of emapalumab-lzsg (Gamifant; Sobi) for the treatment of adult and pediatric patients with hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in known or suspected Still disease, …

Source: Pharmacy Times - Neutral
Published on Jun 30, 2025

FDA Removes REMS Programs for All Currently Approved CD19- and BCMA-Directed CAR T-Cell Therapies in Hematologic ...

The FDA has eliminated the Risk Evaluation and Mitigation Strategies (REMS) programs that were in place for BCMA- and CD19-directed autologous CAR T-cell therapies currently approved for the treatment of patients with various hematologic malignancies, …

Source: OncLive - Pending
Published on Jun 30, 2025

Nestle, Other Food Companies Vow to Ban Artificial Colors

Key Takeaways Nestle and other major food companies are pledging to remove artificial colors from their U.S. food and beverages in the next few years. Petroleum-based artificial colors have been linked to health problems including cancer and behavioral …

Source: The Derby Informer - Kansas - Neutral
Published on Jun 30, 2025

Alzheimer's Setback Hits INmune Bio Stock, But FDA Hopes Remain

INmune Bio Inc. INMB stock is trading lower on Monday, with a session volume of 23.2 million, compared to the average volume of 1.45 million, as per data from Benzinga Pro. The company announced results from its Phase 2 MINDFuL trial evaluating XPro, a …

Source: Benzinga - Neutral
Published on Jun 30, 2025

Clene Inc. Advances Regulatory Strategy For CNM-Au8 With FDA Meetings Scheduled For ALS And MS Programs -

(MENAFN- Evertise Digital) Clene Inc. (NASDAQ: CLNN) has announced significant advancements in its regulatory strategy for CNM-Au8, following a productive Type C meeting with the FDA. The meeting provided valuable feedback on the company's statistical …

Source: MENAFN - Indeterminate
Published on Jun 30, 2025

Biomednewsbreaks Clene Inc. (NASDAQ: CLNN) Advances Regulatory Strategy For CNM-Au8 With FDA Meetings Scheduled For ALS ...

(MENAFN- Investor Brand Network) Clene (NASDAQ: CLNN) announced key regulatory developments following a Type C meeting with the FDA, where it received feedback on its statistical analysis plan (SAP) for evaluating neurofilament light (NfL) biomarker data …

Source: MENAFN - Indeterminate
Published on Jun 30, 2025

FDA accepts new drug application for sublingual epinephrine film

Add topic to email alerts Subscribe We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Key takeaways: Aquestive Therapeutics’ Anaphylm sublingual …

Source: Healio News - Neutral
Published on Jun 30, 2025

FDA Eases Access To Life-Saving Gene Therapies For Blood Cancers

The U.S. Food and Drug Administration (FDA) announced on Friday that it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor CAR T cell immunotherapies. …

Source: Benzinga - Neutral
Published on Jun 30, 2025

FDA Issues CRL to Oxylanthanum Carbonate for Hyperphosphatemia in CKD, Dialysis

The US Food and Drug Administration (FDA) has issued a Complete Response Letter to Unicycive Therapeutics’ New Drug Application for oxylanthanum carbonate for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.1 …

Source: HCPLive - Pending
Published on Jun 30, 2025

Vitalgen’s Gene Therapy Drug VGN-R09b for Primary Parkinson’s Disease Receives FDA Fast Track Designation

SHANGHAI, CHINA, June 30, 2025 /⁨EINPresswire.com⁩/ -- Shanghai Vitalgen BioPharma Co., Ltd. ("Vitalgen") announced that its gene therapy drug, VGN-R09b, for the treatment of Primary Parkinson’s Disease (PD), has received Fast Track …

Distribution channels: Banking, Finance & Investment Industry, Business & Economy ...
Published on Jun 30, 2025

AG Mayes wants to prevent baby food contamination

Arizona Attorney General Kris Mayes urged the FDA to create guidelines to prevent lead and heavy metal contamination in baby food. Mayes highlighted recent recalls of baby food products from Target and Wanabana due to elevated lead levels. She joined other …

Source: AZ Central - Arizona - Neutral
Published on Jun 30, 2025

Chocolate Mousse Recall as FDA Issues Highest Risk Warning

A recall of mousse desserts announced earlier this month has received the highest risk classification by the Food and Drug Administration (FDA). Sabores Fit Bakery, a company in Florida, announced a voluntary recall of a variety of its mousse desserts on …

Source: Newsweek - Left-wing
Published on Jun 30, 2025

FDA approves Sobi’s Gamifant to treat severe inflammatory arthritis complication

The US Food and Drug Administration (FDA) has approved Sobi’s Gamifant (emapalumab-lzsg) as the first-ever treatment for macrophage activation syndrome (MAS) in patients with Still’s disease. The drug has been authorised to treat adult and paediatric …

Source: PMLiVE - Neutral
Published on Jun 30, 2025

Don't make these summer food preparation mistakes

It’s the season of outdoor eating, and chances are you and your family will be hosting a barbecue, enjoying a picnic in the park or roasting hot dogs over an open fire before the summer is through. When the weather turns warm, our meals tend to follow us …

Source: Lancaster Eagle-Gazette - Ohio - Neutral
Published on Jun 30, 2025

FDA’s new mission to speed drug reviews

Between a 20% reduction in workforce in April and the departure of several top officials across departments, the FDA is undergoing a major transition. The job cuts have heightened concerns about potential delays and raised questions about how the federal …

Source: PharmaVoice - Neutral
Published on Jun 30, 2025

Unicycive Therapeutics: FDA Issues CRL For Oxylanthanum Carbonate NDA

Unicycive Therapeutics (UNCY) announced the FDA has issued a CRL for its New Drug Application for OLC to treat hyperphosphatemia in patients with chronic kidney disease on dialysis. Oxylanthanum Carbonate - or OLC - is an investigational oral phosphate …

Source: RTTNews - Neutral
Published on Jun 30, 2025

January - March 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event ...

ELEVIDYS (delandistrogene moxeparvovec-rokl) Hepatotoxicity-associated fatalities in non-ambulatory patients with Duchenne muscular dystrophy FDA is evaluating the need for regulatory action. FDA Safety Communication was issued on June 24, 2025: FDA …

Distribution channels: Healthcare & Pharmaceuticals Industry

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Published on July 1, 2025 - 05:30 GMT

ONWARD Medical Files 510(k) with US FDA for ARC-EX System Home Use and Submits CE Mark Application

FDA 510(k) application submitted to allow marketing of the ARC-EX® System for home use in the United States CE Mark application filed with notified body to enable commercialization of the ARC-EX System in the European Union and other countries EINDHOVEN, …

Distribution channels: Companies, Healthcare & Pharmaceuticals Industry ...
Published on June 30, 2025 - 12:40 GMT

Vitalgen’s Gene Therapy Drug VGN-R09b for Primary Parkinson’s Disease Receives FDA Fast Track Designation

SHANGHAI, CHINA, June 30, 2025 /⁨EINPresswire.com⁩/ -- Shanghai Vitalgen BioPharma Co., Ltd. ("Vitalgen") announced that its gene therapy drug, VGN-R09b, for the treatment of Primary Parkinson’s Disease (PD), has received Fast Track …

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

Published on July 1, 2025 - 00:36 GMT

Mesoblast and FDA Align on Key Items for Revascor® Biologic License Application in Ischemic Heart Failure

NEW YORK, June 30, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced alignment with the United States Food and Drug Administration (FDA) on items required …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on June 30, 2025 - 22:44 GMT

FDA requires expanded labeling about weight loss risk in patients younger than 6 years taking extended-release ...

Through Pediatric Research Equity Act (PREA) postmarketing requirements (PMR), FDA required drug sponsors to evaluate pharmacokinetics (PK), efficacy, and safety of extended-release stimulants in children 4 to 5 years of age. Although the Agency determined …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 30, 2025 - 19:07 GMT

Cutting Edge Foot and Ankle Clinic Now Offers FDA-Cleared Laser Treatment for Toenail Fungus

Nashville-Davidson, June 30, 2025 (GLOBE NEWSWIRE) -- NASHVILLE, Tenn. — Cutting Edge Foot and Ankle Clinic has introduced a new treatment for onychomycosis, more commonly known as toenail fungus. The clinic now offers the FDA-cleared PinPointe FootLaser, …

Distribution channels: Media, Advertising & PR ...
Published on June 30, 2025 - 17:06 GMT

Rocket Pharmaceuticals, Inc. (RCKT) Faces Securities Class Action Amid Protocol Change and FDA’s Clinical Hold on Gene ...

SAN FRANCISCO, June 30, 2025 (GLOBE NEWSWIRE) -- A securities class action lawsuit styled Ho v. Rocket Pharmaceuticals, Inc., et al., No. 3:25-cv-10049 (D. N.J.) has been filed and seeks to represent investors who purchased or otherwise acquired Rocket …

Distribution channels: Consumer Goods, Law ...
Published on June 30, 2025 - 11:00 GMT

Avadel Pharmaceuticals Announces Unanimous Appeals Court Decision Upholding FDA Approval of LUMRYZ in Narcolepsy in ...

DUBLIN, June 30, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced that, on Friday, June 27, 2025, the U.S. Court of Appeals for the District of …

Distribution channels: Healthcare & Pharmaceuticals Industry, Law ...
Published on June 30, 2025 - 12:30 GMT

Minovia Therapeutics Announces FDA Fast Track and Rare Pediatric Disease Designations for MNV-201 in Pearson Syndrome

Haifa, ISRAEL, June 30, 2025 (GLOBE NEWSWIRE) -- Minovia Therapeutics Ltd. (“Minovia” or the “Company”), a clinical-stage biotechnology company developing novel therapies to treat mitochondrial diseases and combat age-related decline, announces that the U. …

Distribution channels: Banking, Finance & Investment Industry, Healthcare & Pharmaceuticals Industry ...

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Food & Beverage Industry Press Releases

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Published on July 1, 2025 - 07:30 GMT

Healthy For Life Foods and Abayance Bay Marina Announce Partnership to Bring Jaca® To The Premier Food Destination

Jaca® Allulose Debuts at Abayance Bay Marina, Bringing Zero-Calorie And Diabetic Friendly Sweetness to Lake Koocanusa’s Finest Food Shop. DELRAY BEACH, FL, UNITED STATES, July 1, 2025 /⁨EINPresswire.com⁩/ -- Healthy For Life Foods, the trailblazer behind …

Distribution channels: Consumer Goods, Culture, Society & Lifestyle ...
Published on July 1, 2025 - 07:15 GMT

ESource AI Course-building Tool Sets Record

ESource L&D Expert Assistant Surpasses Industry Benchmarks with Record-Setting Speed and Automation ATLANTA, GA, UNITED STATES, July 1, 2025 /⁨EINPresswire.com⁩/ -- ESource AI University today announced the latest benchmark results for its …

Distribution channels: Business & Economy, Education ...
Published on July 1, 2025 - 06:49 GMT

Soy Sauce Market is Predicted to Reach USD 83.52 Billion 2032, Expanding at a CAGR of 5.1% From 2025 To 2032

Soy Sauce Market revenue is expected to grow at a CAGR of 5.1% from 2025 to 2032, reaching nearly USD 83.52 Bn by 2032. WILMINGTON, DE, UNITED STATES, July 1, 2025 /⁨EINPresswire.com⁩/ -- Stellar Market Research examines the growth rate of the Soy …

Distribution channels: Food & Beverage Industry ...
Published on July 1, 2025 - 06:47 GMT

Pioneering Australian Agri-Tech, núaFEEDs, Set to Transform UAE Livestock Feed Sector and Tackle Food Waste Challenge

ABU DHABI, ABU DHABI CITY, UNITED ARAB EMIRATES, July 1, 2025 /⁨EINPresswire.com⁩/ -- The UAE's commitment to food security and sustainability initiatives is set to receive a significant boost with the imminent entry of núaFEEDs, an innovative …

Distribution channels: Agriculture, Farming & Forestry Industry, Business & Economy ...
Published on July 1, 2025 - 06:16 GMT

Irish Whiskey Market Share to Reach USD 7.67 Billion by 2027; Industry Compound Annual Growth Rate of 9.2%

Global Irish whiskey industry generated $4.26 billion in 2019, and is expected to reach $7.67 billion by 2027, witnessing a CAGR of 9.2% from 2021 to 2027. WILMINGTON, DE, UNITED STATES, July 1, 2025 /⁨EINPresswire.com⁩/ -- Experimentation and innovation …

Distribution channels: Business & Economy, Food & Beverage Industry ...
Published on July 1, 2025 - 06:15 GMT

Mega Sardines: 50 years of serving nutritionally-packed delicacies to lower income consumers... and primed to go global

A legacy of nutrition, innovation, and malasakit fuels Mega Prime Foods’ next chapter as a global wellness leader. MANILA, PHILIPPINES, July 1, 2025 /⁨EINPresswire.com⁩/ -- A pivot to wellness becomes a vital part of a food company that has been …

Distribution channels: Business & Economy, Companies ...
Published on July 1, 2025 - 05:53 GMT

O Canada, O Crumbl! Celebrate Canada’s Birthday With Festive Desserts

Fireworks of Flavor — From Old Favorites to a New Summer Treat LINDON, UT, UNITED STATES, June 30, 2025 /⁨EINPresswire.com⁩/ -- Grab your maple leaf gear and get ready to celebrate Canada with Crumbl! This year’s Canada Day menu includes fan- …

Distribution channels: Consumer Goods, Culture, Society & Lifestyle ...
Published on July 1, 2025 - 05:48 GMT

Frozen Mushrooms Market Supported by a CAGR of 5.4% by 2032 | Okechamp, Beatnic, Costa Group, Denis Vidmar

The growing awareness regarding vegan products and the rising consumer preference for plant-based options are projected to drive the global market’s growth. WILMINGTON, DE, UNITED STATES, July 1, 2025 /⁨EINPresswire.com⁩/ -- Frozen mushrooms …

Distribution channels: Business & Economy, Food & Beverage Industry ...
Published on June 30, 2025 - 23:30 GMT

Expana and Gluna Shrimp Announce Exclusive Data Partnership Covering Ecuadorian Shrimp Markets

Expana partners with Gluna Shrimp to expand Ecuadorian shrimp pricing data, adding 40+ price points and expert Gabriel Luna to enhance global market insights. LONDON, UNITED KINGDOM, July 1, 2025 /⁨EINPresswire.com⁩/ -- Expana, the world’s largest …

Distribution channels: Agriculture, Farming & Forestry Industry, Consumer Goods ...
Published on June 30, 2025 - 21:15 GMT

Leoforce Launches 24/7 Candidate Engagement Agent to Transform Career Site Conversions

AI-powered Candidate Engagement Agent boosts apply rates, improves candidate quality, and reduces recruiter workload—24/7, across all devices. RALEIGH, NC, UNITED STATES, June 30, 2025 /⁨EINPresswire.com⁩/ -- Leoforce has unveiled its …

Distribution channels: Banking, Finance & Investment Industry, Food & Beverage Industry ...
Published on June 30, 2025 - 18:50 GMT

Third Semi-Annual Pallet Market Survey Finds Buyers, Sellers Cautiously Optimistic on Market Demand, Growth Prospects

Potential impact of tariff policies, lumber prices, rising operating costs and economic uncertainty weigh on market sentiment. SOUTH PLAINFIELD, NJ, UNITED STATES, June 30, 2025 /⁨EINPresswire.com⁩/ -- PalletTrader, the U.S. supply chain industry’ …

Distribution channels: Agriculture, Farming & Forestry Industry, Building & Construction Industry ...
Published on June 30, 2025 - 18:26 GMT

U.S. Supreme Court Swats Away Pork Industry's Latest Challenge to Proposition 12

Animal Wellness Action and the Center for a Humane Economy applaud high court’s refusal to undermine landmark animal welfare law WASHINGTON , DC, UNITED STATES, June 30, 2025 /⁨EINPresswire.com⁩/ -- Today, the U.S. Supreme Court declined to accept …

Distribution channels: Agriculture, Farming & Forestry Industry, Environment ...
Published on June 30, 2025 - 17:37 GMT

FMS President Chris Conner & Global Franchise CEO Paulo Mauro Co-Author New Book The Future of Franchising

Franchise development & sales experts co-author book covering key questions & strategies to take business to next level in franchising’s competitive landscape. ATLANTA, GA, UNITED STATES, June 30, 2025 /⁨EINPresswire.com⁩/ -- Atlanta-based …

Distribution channels: Business & Economy, Companies ...
Published on June 30, 2025 - 16:52 GMT

Surcheros Celebrates Midyear Growth, Plans 10 New Units by End of 2025

ALPHARETTA, GA, UNITED STATES, June 30, 2025 /⁨EINPresswire.com⁩/ -- Surcheros, a community favorite rooted in bold flavors with Southern hospitality, continues to grow its footprint across the Southeast, most recently expanding into South Carolina …

Distribution channels: Business & Economy, Companies ...
Published on June 30, 2025 - 16:06 GMT

Owners of Zotter Chocolates US Star in Their Own Episode of Legacy Makers TV on Inside Success TV

Andreas and Barbara Dolleschal, owners of Zotter Chocolates US, share their extraordinary journey of grit, determination, and reinvention CAPE CORAL, FL, UNITED STATES, June 30, 2025 /⁨EINPresswire.com⁩/ -- Andreas and Barbara Dolleschal, owners …

Distribution channels: Companies, Education ...
Published on June 30, 2025 - 16:00 GMT

Qalitex Laboratories Raises Concern Over Stability Data Gaps in Novel Dosage Formats

Qalitex urges brands to rethink how gummies and stick packs are validated, highlighting stability issues missed by standard testing protocols. IRVINE, CA, UNITED STATES, June 30, 2025 /⁨EINPresswire.com⁩/ -- As innovation in consumer product …

Distribution channels: Chemical Industry, Food & Beverage Industry ...
Published on June 30, 2025 - 15:45 GMT

Roam Tillamook Unveils New Year-Round Cabins on the Oregon Coast

Located in the historic fishing village of Garibaldi, the cabins feature sweeping views of scenic Tillamook Bay GARIBALDI, OR, UNITED STATES, June 30, 2025 /⁨EINPresswire.com⁩/ -- Roam America is proud to announce the addition of 20 new cabins at …

Distribution channels: Culture, Society & Lifestyle, Food & Beverage Industry ...
Published on June 30, 2025 - 15:00 GMT

NECESITA TEQUILA LAUNCHES WITH A BOLD, FEMALE-LED SPIRIT AND A STORY WORTH SIPPING TO

Introducing NECESITA Tequila: sparked in a global shutdown, distilled through perseverance, and now raising the bar for what tequila can be. PORTLAND, OR, UNITED STATES, June 30, 2025 /⁨EINPresswire.com⁩/ -- NECESITA TEQUILA LAUNCHES WITH A BOLD, …

Distribution channels: Food & Beverage Industry ...
Published on June 30, 2025 - 14:49 GMT

Perkins Griddle & Go Coming To Middlesex County

Entrepreneurs sign 10-unit deal to expand fast casual brand in New Jersey EAST BRUNSWICK, NJ, UNITED STATES, June 30, 2025 /⁨EINPresswire.com⁩/ -- East Brunswick entrepreneurs and residents Praveen and Geetha Appana recently signed a 10-unit …

Distribution channels: Business & Economy, Companies ...
Published on June 30, 2025 - 14:20 GMT

Young Entrepreneur Brings Kitchen Guard Franchise to Orange County, California

28-Year-Old Elijah Arcos Secures Five-Territory Deal, Expands Life-Saving Kitchen Safety Services Across Southern California ORANGE COUNTY, CA, UNITED STATES, June 30, 2025 /⁨EINPresswire.com⁩/ -- At just 28 years old, Elijah Arcos is stepping …

Distribution channels: Business & Economy, Companies ...