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Published on Jul 2, 2025

Regulatory tracker: With FDA filing, J&J targets Caplyta expansion into schizophrenia relapse prevention

Welcome to Fierce Pharma's regulatory tracker for the second half of 2025. On this page, we're recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Be sure to come back regularly …

Source: Fierce Pharma - Neutral

06 days 05:16:01

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Published on July 8, 2025 - 20:05 GMT

Solid Biosciences Announces FDA IND and Health Canada CTA Approval for First-in-Class Cardiac Gene Therapy to Treat ...

- SGT-501 is a novel gene therapy for rare, life-threatening, genetic arrhythmogenic disease with no approved therapies - - SGT-501 has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA - - Solid expects to initiate Phase …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on July 8, 2025 - 13:15 GMT

Longeveron® Announces U.S. FDA Approval of IND Application for a Phase 2 Pivotal Registration Study Evaluating ...

Accepted IND application allows for development program to move directly to a Phase 2 pivotal registration clinical trial Phase 2 clinical trial initiation anticipated in first half of 2026 Pediatric cardiomyopathies affect at least 100,000 children …

Distribution channels: Technology ...

Published on July 8, 2025 - 22:21 GMT

Mondelēz Global LLC Conducts U.S. Voluntary Recall of Four Carton Sizes of RITZ Peanut Butter Cracker Sandwiches Due ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Food & Beverage Industry
Published on July 8, 2025 - 11:52 GMT

ZyVersa Therapeutics Supports FDA-Authorized Emergency Compassionate Use of Cholesterol Efflux Mediator™ VAR 200 in a ...

ApoCII amyloidosis, resulting from abnormal organ deposition of toxic fibrillar amyloid proteins, is an ultra-rare condition that mostly affects the kidneys and manifests with protein spillage into the urine (proteinuria) and chronic kidney disease. …

Distribution channels: Healthcare & Pharmaceuticals Industry, Media, Advertising & PR ...

Published on July 8, 2025 - 10:50 GMT

Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-600 (Desmopressin Oral Solution)

- NDA assigned a Target Action Date of February 25, 2026 - - Product has patent protection through 2044 - DEER PARK, Ill., July 08, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on July 8, 2025 - 21:45 GMT

Mondelēz Global LLC Conducts U.S. Voluntary Recall of Four Carton Sizes of RITZ Peanut Butter Cracker Sandwiches Due ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Food & Beverage Industry
Published on July 8, 2025 - 21:22 GMT

Mondelēz Global LLC Conducts U.S. Voluntary Recall of Four Carton Sizes of RITZ Peanut Butter Cracker Sandwiches Due ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Consumer Goods
Published on July 8, 2025 - 20:01 GMT

Rhythm Pharmaceuticals To Announce Topline Results from Phase 2 Trial Evaluating Oral MC4R Agonist Bivamelagon in ...

BOSTON, July 08, 2025 (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 Company …

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

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Food & Beverage Industry Press Releases

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Published on July 8, 2025 - 21:58 GMT

Juan Valdez® Becomes Official Coffee of the LA Rams

Green Coffee Company and Los Angeles Rams Announce New Multi-Year Partnership to Make Juan Valdez® the Official Coffee of the Rams MIAMI, FL, UNITED STATES, July 8, 2025 /⁨EINPresswire.com⁩/ -- Today, Green Coffee Company and the Los Angeles Rams …

Distribution channels: Business & Economy, Culture, Society & Lifestyle ...
Published on July 8, 2025 - 21:36 GMT

Alphatechs USA Presents Innovative School Cafeteria Scanners at SNA ANC 2025

Alphatechs USA is proud to present its line of innovative school lunch scanners for K12 cafeterias at SNA ANC 2025 in San Antonio. TX. IRVINE, CA, CA, UNITED STATES, July 8, 2025 /⁨EINPresswire.com⁩/ -- Alphatechs USA is proud to present its line …

Distribution channels: Conferences & Trade Fairs, Education ...
Published on July 8, 2025 - 21:12 GMT

Yala Greek Ice Cream Makes U.S. Debut on National Ice Cream Day

Greek American founder rooted in D.C. and Baltimore opens America’s first authentic Greek ice cream shop in Georgetown WASHINGTON, DC, UNITED STATES, July 8, 2025 /⁨EINPresswire.com⁩/ -- This summer, Washington, DC will make history as the first U …

Distribution channels: Culture, Society & Lifestyle, Food & Beverage Industry ...
Published on July 8, 2025 - 20:47 GMT

Sweet Robo Wraps Pilot with Food Bazaar Supermarket Chain, Bringing a Fun New Store Experience

Sweet Robo’s high-tech vending machines drive new engagement and excitement in grocery retail through its successful Food Bazaar pilot program. BROOKLYN, NY, UNITED STATES, July 8, 2025 /⁨EINPresswire.com⁩/ -- Sweet Robo, the leader in interactive …

Distribution channels: Amusement, Gaming & Casino, Food & Beverage Industry ...
Published on July 8, 2025 - 19:00 GMT

Magnetic Products, Inc. Launches Redesigned Website to Deliver Streamlined User Experience and Enhanced Product Access

Magnetic Products, Inc. (MPI), New Site Structure, Navigation, and Content Support Customer Success Across Industries HIGHLAND, MI, UNITED STATES, July 8, 2025 /⁨EINPresswire.com⁩/ -- Magnetic Products, Inc. (MPI), a leading provider of magnetic …

Distribution channels: Food & Beverage Industry ...
Published on July 8, 2025 - 18:48 GMT

Gallivant Mawa Ice Cream Lands in Minnesota

Now Scooping in 29 Lunds & Byerlys Stores Across the North Star State HOUSTON, TX, UNITED STATES, July 8, 2025 /⁨EINPresswire.com⁩/ -- Gallivant Mawa Ice Cream, the Texas-based brand known for its globally inspired flavors and rich, creamy …

Distribution channels: Food & Beverage Industry ...
Published on July 8, 2025 - 18:01 GMT

xosialX Introduces Low-Cost Business Entry Program Amid Shifting Wellness Industry Trends

The “Business in a Bag” package centers around XILERATE, xosialX’s new clean energy sachet. RENO, NV, UNITED STATES, July 8, 2025 /⁨EINPresswire.com⁩/ -- xosialX, a wellness and lifestyle company operating across North America and Europe, has …

Distribution channels: Beauty & Hair Care, Business & Economy ...
Published on July 8, 2025 - 17:41 GMT

Clean Remedies Highlights Commitment to Transparency Through Comprehensive Third-Party Lab Testing

Clean Remedies, a CBD and THC company, is highlighting the rigorous third-party lab testing behind all its products. AVON, OH, UNITED STATES, July 8, 2025 /⁨EINPresswire.com⁩/ -- Clean Remedies, a family-owned CBD and THC company, is highlighting …

Distribution channels: Consumer Goods, Culture, Society & Lifestyle ...
Published on July 8, 2025 - 17:00 GMT

The Houstonian Hotel, Club & Spa Named No. 1 Resort in Texas in 2025 Travel + Leisure World’s Best Awards

Voted No. 1 Resort in Texas by Travel + Leisure readers, The Houstonian delivers luxury, wellness, and Southern charm on 27 wooded acres in Houston. HOUSTON, TX, UNITED STATES, July 8, 2025 /⁨EINPresswire.com⁩/ -- Travel + Leisure has announced …

Distribution channels: Conferences & Trade Fairs, Culture, Society & Lifestyle ...
Published on July 8, 2025 - 16:36 GMT

JUARA Announces Limited-Time July Promotions Featuring Signature Skincare Products

JUARA, the skincare and wellness brand inspired by the ancient Indonesian tradition of Jamu, is pleased to announce two limited-time promotions for July. NEW YORK, NY, UNITED STATES, July 8, 2025 /⁨EINPresswire.com⁩/ -- JUARA, the skincare and …

Distribution channels: Beauty & Hair Care, Consumer Goods ...
Published on July 8, 2025 - 16:35 GMT

Oola Bowls® Opens New Location at The Grove in Malvern, PA on July 12 with Grand Opening Celebration

MALVERN, PA, UNITED STATES, July 8, 2025 /⁨EINPresswire.com⁩/ -- Oola Bowls, the vibrant better-for-you brand known for its signature, high-pulp açaí bowls and commitment to “what happiness tastes like,” is thrilled to open its second Chester …

Distribution channels: Food & Beverage Industry, Retail ...
Published on July 8, 2025 - 16:00 GMT

Stella Rising Launches TokTrak.io: First Dedicated TikTok Rank Tracking Platform for Brands and Agencies

Revolutionary SaaS Platform Enables Brands to Track Organic Search Performance on TikTok for the First Time SOUTHPORT, CT, UNITED STATES, July 8, 2025 /⁨EINPresswire.com⁩/ -- Stella Rising, a leading digital marketing agency focused on accelerating …

Distribution channels: Beauty & Hair Care, Consumer Goods ...
Published on July 8, 2025 - 15:59 GMT

Limegreen Southeast Asian Grill: Bringing a Culinary Vision to Life at UT Austin

An Innovative Adaptive Reuse Project West Campus at the University of Texas at Austin AUSTIN, TX, UNITED STATES, July 8, 2025 /⁨EINPresswire.com⁩/ -- Limegreen Southeast Asian Grill, a vibrant fast-casual Asian food restaurant, is two months away from …

Distribution channels: Building & Construction Industry, Business & Economy ...
Published on July 8, 2025 - 15:30 GMT

Ale-8-One Goes Tropical Announcing Launch of PAWPAW Ale-8

Ale-8-One goes tropical with their latest summer limited launch of Pawpaw Ale-8, a crystal-clear soda based on the local fruit. WINCHESTER, KY, UNITED STATES, July 8, 2025 /⁨EINPresswire.com⁩/ -- Ale-8-One goes tropical with their latest summer …

Distribution channels: Food & Beverage Industry ...
Published on July 8, 2025 - 15:11 GMT

Faex Health Launches Free App That Delivers Instant Gut Insights—No Labs, No Guesswork

Gut health has entered the mainstream, but understanding what’s really going on inside your body is still too often expensive. Faex Health is changing that... BOULDER, CO, UNITED STATES, July 8, 2025 /⁨EINPresswire.com⁩/ -- Gut health has entered …

Distribution channels: Beauty & Hair Care, Food & Beverage Industry ...
Published on July 8, 2025 - 15:04 GMT

Retirement Tax Consultants Unveils Roth Conversion Strategy That Cuts Taxes by 35% or More

The Best Way to Save on Roth Conversion Taxes Your CPA or Financial Adviser Doesn't Know About MCKINNEY, TX, UNITED STATES, July 8, 2025 /⁨EINPresswire.com⁩/ -- Retirement Tax Consultants, a national leader in retirement tax and income …

Distribution channels: Banking, Finance & Investment Industry, Culture, Society & Lifestyle ...
Published on July 8, 2025 - 15:00 GMT

Zotter Chocolates Launches Golden Ticket Contest, a Real-Life 'Willy Wonka' Experience at the Zotter Factory in Austria

This unique competition offers chocolate enthusiasts the extraordinary opportunity to win an all-expenses-paid trip to the Zotter Chocolate Factory in Austria. FORT MYERS, FL, UNITED STATES, July 8, 2025 /⁨EINPresswire.com⁩/ -- Zotter Chocolates …

Distribution channels: Amusement, Gaming & Casino, Consumer Goods ...
Published on July 8, 2025 - 14:30 GMT

Global Cocoa Market to Surpass USD 96 Billion by 2035, Growing at a CAGR of 5.4%

The cocoa butter segment projected to grow at a CAGR of 4.0%, whereas the cocoa liquor segment is likely to grow at 6.1%. In terms of countries, India projected MD, UNITED STATES, July 8, 2025 /⁨EINPresswire.com⁩/ -- The global cocoa market is expected to …

Distribution channels: Food & Beverage Industry ...
Published on July 8, 2025 - 14:12 GMT

Forward in The Field Event Showcases Innovation and Honors Agricultural Leadership in Franklin County, Tennessee

3 Rivers Energy Partners hosted Forward in The Field in Franklin County, showcasing autonomous fertilizer system and honoring 2024 TN Young Farmers of the Year. FRANKLIN COUNTY, TN, UNITED STATES, July 8, 2025 /⁨EINPresswire.com⁩/ -- 3 Rivers …

Distribution channels: Agriculture, Farming & Forestry Industry, Energy Industry ...
Published on July 8, 2025 - 14:00 GMT

Bonanno Concepts Makes Restaurant History With Triple Wine Spectator Award Sweep

Mizuna, Luca, and Osteria Marco Score Coveted Wine Industry Honors DENVER, CO, UNITED STATES, July 8, 2025 /⁨EINPresswire.com⁩/ -- They're popping bottles over at Bonanno Concepts, yet again recognized by the prestigious Wine Spectator Restaurant …

Distribution channels: Food & Beverage Industry ...