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Published on November 12, 2024 - 20:58 GMT

Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers

Docket Number: FDA-2016-D-2285 Issued by: Guidance Issuing Office Center for Veterinary Medicine Center for Drug Evaluation and Research Center for Devices and Radiological Health Center for Biologics Evaluation and Research Office of the Commissioner OMB …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on November 12, 2024 - 19:57 GMT

FDA Rationale for Recognition Decision: Cefiderocol

FDA has reevaluated data supporting cefiderocol breakpoints against Stenotrophomonas maltophilia. The review included data submitted to FDA under the cefiderocol new drug application, published literature, and materials presented at a Clinical and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 12, 2024 - 17:54 GMT

NovaBone Secures FDA Clearance for Expanded Indications of Putty in Interbody Fusion Applications

ALACHUA, FL, UNITED STATES, November 12, 2024 /⁨EINPresswire.com⁩/ -- NovaBone Products, a leader in synthetic bone graft solutions, has announced its latest milestone: FDA clearance for its bioactive synthetic bone graft, NovaBone Putty, now …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on November 12, 2024 - 06:00 GMT

Best Vascular/Novoste Celebrates the 24th Anniversary of Vascular Brachytherapy Approval & Use of by US FDA

WASHINGTON, DC, UNITED STATES, November 12, 2024 /⁨EINPresswire.com⁩/ -- It has been over 30 years since the first vascular brachytherapy (VBT) animal experiments and human clinical trials were performed and 24 years since the approval of VBT for …

Distribution channels: Companies, Conferences & Trade Fairs ...

Published on November 12, 2024 - 14:00 GMT

Philips Spectral CT 7500 RT, world’s first spectral 4DCT respiratory-gated imaging receives FDA 510(k) clearance

November 12, 2024 Designed specifically for use in radiation oncology, new Spectral CT 7500 RT enables personalized radiation therapy planning to deliver better care for more cancer patients Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on November 12, 2024 - 13:00 GMT

Intercept Receives Complete Response Letter from FDA Addressing OCALIVA supplemental New Drug Application (sNDA)

MORRISTOWN, N.J., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a wholly owned biopharmaceutical subsidiary of Alfasigma S.p.A., today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter ( …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on November 12, 2024 - 13:00 GMT

Actuate Announces FDA Rare Pediatric Disease Designation Granted to Elraglusib for Treatment of Ewing Sarcoma

Ewing Sarcoma is a Highly Metastatic Form of Sarcoma and the Second Most Prevalent Primary Malignant Tumor in Children and Adolescents Ongoing Enrollment in Phase 1/2 Trial of Elraglusib in Relapsed/Refractory Ewing Sarcoma with Topline Phase 1 …

Distribution channels: Healthcare & Pharmaceuticals Industry, Technology ...
Published on November 12, 2024 - 13:00 GMT

iCAD's ProFound Detection Version 4.0 Gains FDA Clearance

NASHUA, N.H., Nov. 12, 2024 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD) (“iCAD” or the “Company”) a global leader in clinically proven AI-powered cancer detection solutions, announced today that its ProFound Detection Version 4.0 for Digital Breast …

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

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Published on November 12, 2024 - 21:08 GMT

lil Coffea Shops in Denver Now Open 24 Hours

TWO OF DENVER'S FAVORITE CAFE'S NOW JOINING THE ALL NIGHT SCENE DENVER, CO, UNITED STATES, November 12, 2024 /⁨EINPresswire.com⁩/ -- Lil Coffea Shops, local coffee spots in Denver, have announced that both locations are now open 24 hours …

Distribution channels: Food & Beverage Industry ...
Published on November 12, 2024 - 21:04 GMT

Football, Fandom, and Mental Health: Savvy Seats Changes the Game

A unique tailgating experience at MetLife Stadium merges game-day excitement with meaningful conversations on mental health EAST RUTHERFORD, NJ, UNITED STATES, November 12, 2024 /⁨EINPresswire.com⁩/ -- Football season just got a whole lot more …

Distribution channels: Culture, Society & Lifestyle, Food & Beverage Industry ...
Published on November 12, 2024 - 20:00 GMT

PACIFIC BELLS OPENS NEWEST TACO BELL IN CHIPPEWA FALLS

Join the grand opening fiesta early for a chance to win Free Taco Bell for a Year, Nov. 15 CHIPPEWA FALLS, WI, UNITED STATES, November 12, 2024 /⁨EINPresswire.com⁩/ -- Pacific Bells, a leading Taco Bell franchisee operating nearly 300 Taco Bell …

Distribution channels: Business & Economy, Companies ...
Published on November 12, 2024 - 18:35 GMT

Sign-up Surge as Utahns Feed Children During Holiday Break

SALT LAKE CITY, UT, UNITED STATES, November 12, 2024 /⁨EINPresswire.com⁩/ -- Utahns have showcased unparalleled support for USANA Foundation’s initiative to combat child hunger, reserving in the first week a remarkable 80% of the food bags …

Distribution channels: Food & Beverage Industry, Human Rights ...
Published on November 12, 2024 - 18:30 GMT

Cactus-Based Beverage Innovator Caliwater Announces Official Partnership with American Forests

LOS ANGELES, CA, UNITED STATES, November 12, 2024 /⁨EINPresswire.com⁩/ -- Caliwater, a leading innovator in plant-based hydration beverages, is proud to announce an official partnership with American Forests. Caliwater and American Forests are …

Distribution channels: Agriculture, Farming & Forestry Industry, Companies ...
Published on November 12, 2024 - 17:43 GMT

Lavae McClinnahan Introduces Montauk: A Sophisticated Coastal Dining Experience in Redondo Beach

Entrepreneur and restauranteur is set to open the highly anticipated Montauk: a chic coastal dining establishment in Redondo Beach, CA. REDONDO BEACH, CA, UNITED STATES, November 12, 2024 /⁨EINPresswire.com⁩/ -- Renowned entrepreneur Lavae …

Distribution channels: Food & Beverage Industry ...
Published on November 12, 2024 - 17:33 GMT

C-store prepared beverage success requires strategic approach to value and innovations, finds Technomic report

CHICAGO, IL, UNITED STATES, November 12, 2024 /⁨EINPresswire.com⁩/ -- Due to the ongoing inflationary environment, disconnect exists between operators and consumers when it comes to pricing of prepared beverages at c-stores. Nearly three in 10 c- …

Distribution channels: Food & Beverage Industry ...
Published on November 12, 2024 - 16:38 GMT

Arbol Eatery, a division of Monarca Food Group, and InterNations Host Vibrant Diwali Celebration in Uptown Charlotte

Arbol Eatery, Monarca Food Group, and InterNations celebrate Diwali with vibrant decor, diverse cuisine, and cultural performances in Uptown Charlotte. CHARLOTTE, NC, UNITED STATES, November 12, 2024 /⁨EINPresswire.com⁩/ -- Charlotte’s vibrant …

Distribution channels: Business & Economy, Culture, Society & Lifestyle ...
Published on November 12, 2024 - 16:15 GMT

Global Herbal Supplements Market Set For 7.3% Growth, Reaching $66.77 Billion By 2028

Herbal Supplements Global Market Report 2024 – Market Size, Trends, And Forecast 2024-2033 LONDON, GREATER LONDON, UNITED KINGDOM, November 12, 2024 /⁨EINPresswire.com⁩/ -- The Business Research Company’s Early Year-End Sale! Get up to 30% off …

Distribution channels: Business & Economy, Food & Beverage Industry ...
Published on November 12, 2024 - 16:13 GMT

Huddle House Elevates Comfort Classics with New Maple Butter Chicken & Waffle Lineup

Meets Demand with Improved and Portable Menu Additions ATLANTA, GA, UNITED STATES, November 12, 2024 /⁨EINPresswire.com⁩/ -- Huddle House, serving freshly prepared, homestyle food since 1964, is continuing to take its menu innovation to new …

Distribution channels: Companies, Culture, Society & Lifestyle ...
Published on November 12, 2024 - 16:09 GMT

Handel’s Homemade Ice Cream Debuts in Georgia with Cumming Grand Opening

Join the Celebration on Nov. 21 Where the First 100 Guests Receive Free Ice Cream for a Year! CUMMING, GA, UNITED STATES, November 12, 2024 /⁨EINPresswire.com⁩/ -- Handel’s Homemade Ice Cream is scooping up something sweet in the Peach State! …

Distribution channels: Business & Economy, Companies ...
Published on November 12, 2024 - 16:06 GMT

TOSLA Nutricosmetics Named Finalist for the Prestigious Cosmetics & Toiletries Allē Awards 2025 for Lumina365 Supplement

TOSLA Nutricosmetics is thrilled to be a finalist in the Ingredient Blend: Color, Sun, and Nutricosmetic category at the Cosmetics & Toiletries Allē Awards. AJDOVščINA, SLOVENIA, November 12, 2024 /⁨EINPresswire.com⁩/ -- Innovation and …

Distribution channels: Beauty & Hair Care, Business & Economy ...
Published on November 12, 2024 - 15:15 GMT

New Research Shows U.S. Agriculture Has Potential to be Greenhouse Gas Negative

Peer-reviewed report provides more scientific evidence that agriculture is part of the solution to climate change PARK RIDGE, IL, UNITED STATES, November 12, 2024 /⁨EINPresswire.com⁩/ -- U.S. agriculture, with enhanced implementation of …

Distribution channels: Agriculture, Farming & Forestry Industry, Environment ...
Published on November 12, 2024 - 14:45 GMT

Modern Businesses Embrace Containers4Less for Strategic Storage Container Rentals

The use of 20’ and 40’ storage container rentals has become a strategic choice for many industries, particularly in construction. RALEIGH, NC, UNITED STATES, November 12, 2024 /⁨EINPresswire.com⁩/ -- As business storage needs have evolved, so has …

Distribution channels: Building & Construction Industry, Companies ...
Published on November 12, 2024 - 14:26 GMT

Beverage Packaging Market: Shaping the Future of Consumer Convenience and Sustainability | S&S Insider

"The Beverage Packaging Market is adapting to provide innovative, eco-friendly solutions that prioritize convenience & enhance the overall drinking experience." AUSTIN, TX, UNITED STATES, November 12, 2024 /⁨EINPresswire.com⁩/ -- The …

Distribution channels: Food & Beverage Industry ...
Published on November 12, 2024 - 14:26 GMT

Soluble Fiber Market to USD 5.01 Billion by 2032 | Increasing Awareness of Health Benefits

Soluble fiber is known for its benefits, including lowering cholesterol levels, stabilizing blood sugar, supporting weight management, and improving gut health. AUSTIN, TX, UNITED STATES, November 12, 2024 /⁨EINPresswire.com⁩/ -- The Soluble Fiber …

Distribution channels: Food & Beverage Industry ...
Published on November 12, 2024 - 14:26 GMT

Alcohol Packaging Market Set to Reach $112.97 Bn by 2032, Fuelled by Shifts Toward Sustainability & E-commerce Expansion

Alcohol Packaging Market is experiencing steady growth, fuelled by a rise in consumption trends & shift towards sustainable & innovative packaging solutions. AUSTIN, TX, UNITED STATES, November 12, 2024 /⁨EINPresswire.com⁩/ -- The Alcohol …

Distribution channels: Food & Beverage Industry ...
Published on November 12, 2024 - 14:05 GMT

YRC Launches Comprehensive Business Plan Writing Services to Empower Startups & SMEs in Securing Funding, Driving Growth

A business plan is crucial for startups and SMEs to attract investors and build their confidence in investing. PUNE, MAHARASHTRA, INDIA, November 12, 2024 /⁨EINPresswire.com⁩/ -- A business plan has several imperative functions and repercussions …

Distribution channels: Business & Economy, Consumer Goods ...
Published on November 12, 2024 - 14:00 GMT

Rockit™ Apple Partners with Elite Supercross Team, Host Grindstone Friesen Group

Sponsorship Supports Pro Riders Max Sanford and Dylan Walsh, and the Grindstone Compound’s Training Facility. CHELAN, WA, UNITED STATES, November 12, 2024 /⁨EINPresswire.com⁩/ -- Rockit™ Apple announces a new partnership with Host Grindstone …

Distribution channels: Agriculture, Farming & Forestry Industry, Culture, Society & Lifestyle ...
Published on November 12, 2024 - 13:47 GMT

New byko-visc CP Cone & Plate Viscometers

Accurate, Repeatable, and Technologically Advanced Line of Precision Viscometers powered by Direct Drive Technology COLUMBIA, MD, UNITED STATES, November 12, 2024 /⁨EINPresswire.com⁩/ -- BYK-Gardner USA, a worldwide partner of the automotive, …

Distribution channels: Beauty & Hair Care, Chemical Industry ...