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Published on Jul 26, 2025

US FDA grants Fast Track designation to Solid Biosciences' SGT─501, an AAV─based l gene therapy to treat ...

Solid Biosciences Inc., a clinical stage life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, announced that it received Fast Track designation from the US Food and Drug Administration (FDA) for SGT-501, the …

Source: Pharmabiz.com - Neutral
Published on Jul 26, 2025

FDA delays approval decision for Bayer menopause therapy

The Food and Drug Administration has delayed its review of a Bayer therapy for hot flashes related to menopause, telling the drugmaker it needs additional to review the company’s application. In a Friday statement, Bayer said the FDA did not raise any …

Source: BioPharma Dive - Pending
Published on Jul 25, 2025

FDA extends review period for Bayer's elinzanetant for vasomotor symptoms

Menopause patients may have to wait a little longer for another treatment for vasomotor symptoms due in part to the FDA's recent decision to extend the review period for Bayer's elinzanetant, the first neurokinin 1 and neurokinin 3 receptor …

Source: Contemporary OB/GYN - Pending
Published on Jul 25, 2025

US FDA extends review of Bayer’s menopause relief drug

Audio By Carbonatix (Reuters) -The U.S. Food and Drug Administration has extended its review of Bayer’s experimental menopause relief drug, the German drugmaker said on Friday. The non-hormonal treatment, elinzanetant, is being reviewed for relieving …

Source: SRN News - Center-right
Published on Jul 25, 2025

FDA Extends Review Period for Elinzanetant NDA for Menopausal Vasomotor Symptoms

The US FDA has extended its review of Bayer’s New Drug Application (NDA) for elinzanetant, a first-in-class dual neurokinin-1 and neurokinin-3 receptor antagonist, for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause, …

Source: Patient Care - Pending
Published on Jul 25, 2025

Health Canada approves Clearside Biomedical’s Xipere for suprachoroidal treatment for uveitic macular edema

Clearside Biomedical, Inc., a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS), announced that Health Canada has granted approval for Xipere (triamcinolone acetonide …

Source: Pharmabiz.com - Neutral
Published on Jul 25, 2025

Cheap drugs from Canada can't make America healthy

The U.S. Food and Drug Administration recently announced plans to help states and Indian tribes purchase certain prescription drugs from Canada, where brand-name medicines tend to be cheaper because the government caps their price. The new guidance is part …

Source: Imperial Valley Press - California - Neutral
Published on Jul 25, 2025

US FDA extends the review period for GSK’s Blenrep combinations to treat relapsed/refractory multiple myeloma

GSK plc announced the US Food and Drug Administration (FDA) has extended the review period for the Biologics License Application (BLA) for Blenrep combinations for the treatment of patients with relapsed or refractory multiple myeloma who have received at …

Source: Pharmabiz.com - Neutral
Published on Jul 25, 2025

Belantamab Mafodotin Combos Receive EU, Canadian Approval for R/R Myeloma

The European Commission and Health Canada have approved belantamab mafodotin (Blenrep) in combination with bortezomib (Velcade) and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at …

Source: OncLive - Pending
Published on Jul 24, 2025

FDA grants priority review to expanded indication of flibanserin in HSDD

The FDA has granted priority review to a supplemental application seeking an expanded approval of flibanserin (Addyi, 100 mg) to treat hypoactive sexual desire disorder (HSDD) in postmenopausal women, Sprout Pharmaceuticals announced in a news release.1 …

Source: Urology Times - Pending
Published on Jul 24, 2025

Louisiana and Texas Pass Laws Requiring Warning Labels for Certain Food Ingredients

[co-author: Heather Olson, 2025 Summer Associate] Key Takeaways What happened: Two recently enacted laws in Louisiana and Texas will each require separate warning labels on the packaging of food sold in their state if the food contains any of 44 specific …

Source: JD Supra - California - Neutral
Published on Jul 26, 2025

The first 100% effective HIV prevention drug is approved and going global

An epidemic that's been sustained for 44 years might finally be quelled, with the milestone approval of the first HIV drug that offers 100% protection with its twice-yearly injections. It's a landmark achievement that stands to save millions of …

Source: New Atlas - Neutral
Published on Jul 24, 2025

The 3 Best Places to Buy FDA-Approved Gloves for Food Processing

The U.S. Food and Drug Administration (FDA) is the agency responsible for protecting public health. One of its mandates is to oversee the nation’s food supply, processing and preparation. It’s essential to use the correct gloves for food prep — they should …

Source: FoodChain Magazine - Florida - Pending
Published on Jul 25, 2025

Anzupgo FDA Approved as First Treatment Meant for Chronic Hand Eczema in Adults

The FDA approved Anzupgo (delgocitinib) cream today as the first and only treatment specifically for adults with moderate-to-severe chronic hand eczema (CHE) in the United States. Chronic hand eczema is a long-lasting, often painful skin condition that …

Source: Formulary Watch - Pending
Published on Jul 25, 2025

FDA approves Anzupgo for chronic hand eczema

Key takeaways: Anzupgo (delgocitinib) cream 20 mg/g is a steroid-free JAK inhibitor. Data from the DELTA trials demonstrated the drug’s efficacy for moderate to severe chronic hand eczema. The FDA approved Anzupgo for the treatment of moderate to …

Source: Healio News - Neutral
Published on Jul 24, 2025

FDA Grants Fast Track Designation for Sprout's Flibanserin to Treat HSDD in Postmenopausal Women

The FDA has accepted for Priority Review a supplemental new drug application (sNDA) seeking to expand the indication for flibanserin 100 mg to include postmenopausal women with hypoactive sexual desire disorder (HSDD). Flibanserin, marketed as Addyi by …

Source: Patient Care - Pending
Published on Jul 24, 2025

Solid Biosciences Earns FDA Fast Track for SGT-501 Gene Therapy in CPVT

Solid Biosciences Inc., a clinical-stage company focused on genetic medicines for neuromuscular and cardiac diseases, announced it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its investigational gene therapy SGT …

Source: Pharma Journalist - Neutral
Published on Jul 24, 2025

GSK's Blood Cancer Drug Review Extended As FDA Seeks More Data

The US Food and Drug Administration (FDA) on Wednesday extended the review period for the Biologics License Application (BLA) for GSK plc’s GSK Blenrep combinations for relapsed or refractory multiple myeloma patients who have received at least one prior …

Source: Benzinga - Neutral
Published on Jul 24, 2025

GSK adds EU to Blenrep checklist as FDA sets new PDUFA date

GSK has added the European Medicines Agency to the list of regulatory bodies that have approved Blenrep (belantamab mafodotin) for multiple myeloma, following the UK, Japan, Switzerland, Canada, and the United Arab Emirates. As to whether the US will be …

Source: pharmaphorum - Neutral

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Published on July 26, 2025 - 11:08 GMT

REPL CLASS ACTION ALERT: FDA Response Letter Leads to Replimune Group, Inc. Class Action – Investors are Notified to ...

NEW YORK, July 26, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Replimune Group, Inc. (NASDAQ: REPL) and certain of the Company’s senior executives for potential …

Distribution channels: Consumer Goods, Law ...
Published on July 25, 2025 - 11:00 GMT

Sobi Announces U.S. Food and Drug Administration Approves Doptelet® (avatrombopag) for the Treatment of Thrombocytopenia ...

Doptelet Sprinkle (avatrombopag) was approved as an effective formulation for children one year to less than six years. The primary endpoint was met in 27.8% of patients, confirming the efficacy in children and adolescents with persistent or chronic ITP …

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Published on July 25, 2025 - 22:24 GMT

FDA Investigating Death of 8-Year-Old Boy Who Received Elevidys

For Immediate Release: July 25, 2025 The U.S. Food and Drug Administration is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta Therapeutics gene therapy for Duchenne muscular dystrophy. The death occurred on June 7, 2025. The …

Distribution channels: Food & Beverage Industry
Published on July 25, 2025 - 22:42 GMT

FDA Investigating Death of 8-Year-Old Boy Who Received Elevidys

For Immediate Release: July 25, 2025 The U.S. Food and Drug Administration is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta Therapeutics gene therapy for Duchenne muscular dystrophy. The death occurred on June 7, 2025. The …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 25, 2025 - 17:33 GMT

FDA Clinical Hold on RP-A501 Trial Triggers Rocket Pharmaceuticals (RCKT) Stock Plunge and Class Action – Hagens Berman

SAN FRANCISCO, July 25, 2025 (GLOBE NEWSWIRE) -- When, on May 27, 2025, Rocket Pharmaceuticals (NASDAQ: RCKT) revealed that the FDA put a clinical hold on its Phase 2 pivotal trial for RP-A501, an experimental therapy intended to treat patients with a rare …

Distribution channels: Consumer Goods, Law ...
Published on July 24, 2025 - 20:39 GMT

FDA Advancing Generic Drug Development Training Modules

The content provides access to current FDA thinking, emerging scientific approaches, and real-world application strategies that generic drug manufacturers need to succeed in an increasingly complex regulatory environment. Browse courses available on demand …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on July 24, 2025 - 20:39 GMT

FDA Clinical Trials Training Modules

The content reflects current FDA thinking, emerging guidance, and real-world regulatory experience, providing participants with the most reliable and up-to-date information available. Organizations utilizing this training demonstrate their commitment to …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on July 24, 2025 - 20:39 GMT

FDA Pharmaceutical Quality Training Modules

The content provides essential expertise in pharmaceutical quality regulation, supply chain integrity, and manufacturing innovation – equipping professionals with the knowledge to navigate today's complex regulatory landscape and ensure patient safety …

Distribution channels: Healthcare & Pharmaceuticals Industry

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Food & Beverage Industry Press Releases

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Published on July 27, 2025 - 04:14 GMT

From Aristocracy to Authenticity: Cook with a Real Duchess at Butera 28 Apartments in Palermo

PALERMO, ITALY, July 27, 2025 /⁨EINPresswire.com⁩/ -- In an age of curated experiences and instant itineraries, Butera 28 Apartments offers something deeply personal and genuinely Sicilian: cooking with a real Duchess inside a historic palazzo. …

Distribution channels: Companies, Culture, Society & Lifestyle ...
Published on July 27, 2025 - 01:39 GMT

BPX Strengthens SAP Signavio Practice to Deliver Next-Gen Process Intelligence

A world leader in business process consultancy, Business Process Xperts (BPX), has announced a major build-up of its SAP Signavio practice. PUNE, MAHARASHTRA, INDIA, July 27, 2025 /⁨EINPresswire.com⁩/ -- The intention behind this growth is to deliver next …

Distribution channels: Business & Economy, Companies ...
Published on July 27, 2025 - 01:18 GMT

Tom’s Pest Control Perth Delivers Chain-Wide Pest Program for Café Group

Tom’s Pest Control Perth rolls out pest program across 12 cafés, helping the chain stay compliant, pest-free, and consistent with brand hygiene standards. PERTH, WA, AUSTRALIA, July 27, 2025 /⁨EINPresswire.com⁩/ -- Tom’s Pest Control Perth has …

Distribution channels: Building & Construction Industry, Consumer Goods ...
Published on July 27, 2025 - 01:16 GMT

Tom’s Pest Control Brisbane Safely Removes Possum from Warehouse Ceiling Without Disrupting Operations

Tom’s Pest Control Brisbane removes possum from warehouse roof, avoiding damage and disruption. Legal, humane solution with ongoing inspections in place. BRISBANE, QLD, AUSTRALIA, July 27, 2025 /⁨EINPresswire.com⁩/ -- Tom’s Pest Control Brisbane has …

Distribution channels: Building & Construction Industry, Companies ...
Published on July 26, 2025 - 13:00 GMT

A Spirited Honor: Beyond Distilling Company Named 2025 Best of South Carolina Honorable Mention

NORTH CHARLESTON, SC, UNITED STATES, July 26, 2025 /⁨EINPresswire.com⁩/ -- Beyond Distilling Company, a Charleston-based craft distillery known for its bold flavors and inclusive mission, has been named a 2025 Best of South Carolina Honorable Mention …

Distribution channels: Culture, Society & Lifestyle, Food & Beverage Industry ...
Published on July 27, 2025 - 00:54 GMT

Tropicale Foods Recalls Certain Helados Mexico and La Michoacana Products Due to Undeclared Milk

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 26, 2025 - 23:23 GMT

Tropicale Foods Recalls Certain Helados Mexico and La Michoacana Products Due to Undeclared Milk

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 26, 2025 - 22:08 GMT

Tropicale Foods Recalls Certain Helados Mexico and La Michoacana Products Due to Undeclared Milk

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 26, 2025 - 08:45 GMT

Restaurantes en Polanco apuestan por cenas ligeras y equilibradas: Estas son las mejores opciones

Restaurantes en Polanco apuestan por cenas ligeras y saludables, ofreciendo opciones balanceadas que siguen la tendencia del bienestar gastronómico. MEXICO CITY , MEXICO, July 26, 2025 /⁨EINPresswire.com⁩/ -- Los restaurantes en Polanco han sabido …

Distribution channels: Food & Beverage Industry, Travel & Tourism Industry ...
Published on July 25, 2025 - 21:30 GMT

Community Action of Napa Valley Opens Outdoor Learning Center & Playground Thanks to CalFire Grant

The new center expands Community Action of Napa Valley’s mission to nurture, educate, and empower children in need. NAPA, CA, UNITED STATES, July 25, 2025 /⁨EINPresswire.com⁩/ -- Community Action of Napa Valley (CANV) and CANV Kids Development …

Distribution channels: Agriculture, Farming & Forestry Industry, Culture, Society & Lifestyle ...
Published on July 25, 2025 - 20:34 GMT

Bell Springs Winery & Brewery Becomes First in Texas to Brew and Serve 100% Gluten-Free Beer

Hill Country favorite sets a new standard for inclusivity and flavor with a bold lineup brewed entirely from gluten-free ingredients. DRIPPING SPRINGS, TX, UNITED STATES, July 25, 2025 /⁨EINPresswire.com⁩/ -- Bell Springs Winery & Brewery is …

Distribution channels: Food & Beverage Industry ...
Published on July 25, 2025 - 20:22 GMT

From Soirées to Back-to-School Bites, Celebrity Chef and Entertainer George Duran Serves up Summer Family Inspo

NEW YORK, NY, UNITED STATES, July 25, 2025 /⁨EINPresswire.com⁩/ -- Summer is in full swing, bringing backyard BBQs, casual get-togethers, and prep for the busy back-to-school season. Celebrity chef and entertainer George Duran shares tips to elevate summer …

Distribution channels: Consumer Goods, Culture, Society & Lifestyle ...
Published on July 25, 2025 - 19:30 GMT

King Kongin Signals a Health-First Future for Energy Drinks with Natural Formulas and Clean Ingredients

LOS ANGELES, CA, UNITED STATES, July 25, 2025 /⁨EINPresswire.com⁩/ -- In an energy drink industry historically dominated by sugar-packed, artificially flavored beverages, King Kongin is carving a new lane—one rooted in clean, functional ingredients …

Distribution channels: Consumer Goods, Culture, Society & Lifestyle ...
Published on July 25, 2025 - 18:50 GMT

ConServ Introduces 3.2 cu. ft. Retro Convertible Mini Refrigerator-Freezer

HOUSTON, TX, UNITED STATES, July 25, 2025 /⁨EINPresswire.com⁩/ -- ConServ, a trusted name in compact home appliances, announces the launch of the ConServ 3.2 cu. ft. Retro Convertible Refrigerator-Freezer, a versatile and stylish cooling solution …

Distribution channels: Electronics Industry, Food & Beverage Industry ...
Published on July 25, 2025 - 17:47 GMT

Crossover Meats becomes the Official Chef-Inspired Burger of the Kannapolis Cannon Ballers

Crossover Meats is stepping up to the plate this summer through a partnership with the Kannapolis Cannon Ballers, bringing fans bold flavor, smarter nutrition. KANNAOPOLIS, NC, UNITED STATES, July 25, 2025 /⁨EINPresswire.com⁩/ -- Crossover Meats, …

Distribution channels: Consumer Goods, Culture, Society & Lifestyle ...
Published on July 25, 2025 - 16:47 GMT

Peralta Associates and Defense New Integration of Everbridge FIRST Alert is Breaking the Traditional Security Norm

Peralta Associates and Defense is integrating FIRST Alert into its regular security services in order to be more proactive in deterring criminal activity LOS ANGELES, CA, UNITED STATES, July 25, 2025 /⁨EINPresswire.com⁩/ -- Peralta Associates and …

Distribution channels: Building & Construction Industry, Business & Economy ...
Published on July 25, 2025 - 16:34 GMT

Cheese the Day: Easy Ideas for Fun Summer Entertaining

CHICAGO, IL, UNITED STATES, July 25, 2025 /⁨EINPresswire.com⁩/ -- Wowing your guests this summer doesn’t have to be as hard as you might think. Use everyday ingredients found at any grocery store – featuring cheeses, simple accompaniments and …

Distribution channels: Consumer Goods, Culture, Society & Lifestyle ...
Published on July 25, 2025 - 16:28 GMT

Sugar Confectionery Market Size Projected to reach Approximately USD 55,594 Million

Sugar Confectionery Market was valued at $44,481 million in 2015, and is projected to reach $55,594 million by 2022, growing at a CAGR of 3.2% WILMINGTON, DE, UNITED STATES, July 25, 2025 /⁨EINPresswire.com⁩/ -- The demand for sugar confectionery in Asia …

Distribution channels: Business & Economy, Food & Beverage Industry ...
Published on July 25, 2025 - 15:43 GMT

Krak Boba Rolls Out Flavorful New Drinks for Summer

Krak Boba’s summer just got bolder with five new drinks featuring taro, matcha, peach, banana and more! Now available at all locations. ORANGE COUNTY, CA, UNITED STATES, July 25, 2025 /⁨EINPresswire.com⁩/ -- Krak Boba, the innovative Southern …

Distribution channels: Companies, Consumer Goods ...
Published on July 25, 2025 - 14:55 GMT

U.S. and Canada Beauveria Bassiana Market Expected to Reach $98.7 Million by 2035 | CAGR of 9.0%

U.S. and Canada Beauveria Bassiana Market by Type, by Application, by Distribution Channel, by Crop Type: Opportunity Analysis and Industry Forecast, 2024-2035. WILMINGTON, DE, UNITED STATES, July 25, 2025 /⁨EINPresswire.com⁩/ -- U.S. and Canada …

Distribution channels: Agriculture, Farming & Forestry Industry, Food & Beverage Industry ...