Serbia and Montenegro FDA Newswire

Cerapedics Announces FDA Approval of PearlMatrix™ P-15 Peptide Enhanced Bone Graft, The First and Only Proven Bone ...

ASPIRE pivotal Level-1 PMA IDE study evaluated PearlMatrix vs. local autograft in single-level TLIF procedures: - Demonstrated statistically superior fusion speed; - Achieved over twice as many patients fused at six months;  - Included ~60% high-risk …

FDA approves AstraZeneca, Daiichi Sankyo's Datroway in EGFR-mutated lung cancer

FDA's acting CDER head Jacqueline Corrigan-Curay heads for the exit amid period of heavy turnover: reports

Only a few days after reports emerged that the director of the FDA's cell and gene therapy office had been abruptly put on administrative leave, a new departure shows that an intense period of leadership turnover at the agency isn't over. On Monday …

FDA's Accelerated Drug Review Plan Praised By Former Senior Trump Health Official

(MENAFN- PR Newswire) Giroir, CEO of Altesa BioSciences , said: "FDA Commissioner Makary's timely initiative can better enable smaller biotech innovators with breakthrough 'upstream' therapies to compete with Big Pharma's fixation on …

Federal judge upholds FDA’s decision to remove GLP-1 drugs from shortage list

On June 18, a federal judge ruled that the Food and Drug Administration (FDA) acted lawfully when it removed semaglutide (Ozempic, Wegovy) from the drug shortage list, effectively ending legal mass compounding of the medication.  The Outsourcing Facilities …

FDA Recalls Chocolate Candies Over Milk Allergy Risk

Key Takeaways Chocolate candy sold nationwide may contain milk not listed on the label People with milk allergies could have a severe reaction No illnesses have been reported MONDAY, June 23, 2025 (HealthDay News) — Chocolate candy sold across the U.S. is …

Acting CDER Head Becomes Latest in String of FDA Leaders to Leave Agency

The FDA is losing another top regulator amid the ongoing exodus of agency leaders and staffers under the Trump administration. Jacqueline Corrigan-Curay, the acting head of the Center for Drug Evaluation and Research, told employees via email that she is …

STAT+: Pharmalittle: We’re reading about Novo ending Hims deal, FDA transparency, and more

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so-familiar routine of meetings, deadlines, and messages has returned. But what can you do? There is no pause button to …

STAT+: Top drug regulator is retiring as FDA departures mount

WASHINGTON — Jacqueline Corrigan-Curay, the top drug regulator at the Food and Drug Administration, is retiring from the agency in July.  Jacqueline Corrigan-Curay, J.D., M.D.FDA Corrigan-Curay, who took over as acting director of the Center for Drug …

STAT+: FDA chief’s goals of ‘radical transparency’ threatened by agency cuts

WASHINGTON — Even before he took over the Food and Drug Administration, Marty Makary called for frequent, transparent meetings of the independent panels that advise the agency on controversial regulatory decisions. But current and former agency staff, as …

Grandma was wrong: Food myths debunked

A recent survey found 42% of Americans prefer to cook meals traditionally, like their elders. Unfortunately, while we all love Grandma, bless her heart, much of her advice around food was based on folklore and not testing, facts and data. It may have been …

NRx Pharmaceuticals Applies for FDA National Priority Voucher for Intravenous Ketamine (NRX-100)

BREAKING NEWS A new formulation of ketamine is progressing through a novel US Food and Drug Administration review pathway, announced NRx Pharmaceuticals. The company has applied for a Commissioner’s National Priority Voucher (CNPV) for NRX-100, its patent- …

Texas to introduce food-additive warning labels

Texas has passed a legislation that will require food producers to place warning labels on items containing certain artificial colours and additives.  The use of more than 40 substances, including synthetic food dyes and bleached flour, on products sold in …

Archeus Technologies gets FDA approval for ART-101 application

Archeus Technologies has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for ART-101.   This new small molecule is designed for prostate cancer imaging and treatment.   The FDA’s approval …

FDA Recalls Chocolate Candies Over Milk Allergy Risk

US FDA clears Lomond Therapeutics’ IND application for phase 1 multicenter study of lonitoclax in patients with relapsed/...

Lomond Therapeutics Holdings, Inc. (Lomond Therapeutics), a clinical-stage biotechnology company dedicated to discovering and developing potentially best-in-class and first-in-class medicines for the treatment of haematological malignancies, announced that …

Sanofi/Regeneron’s Dupixent granted FDA approval for bullous pemphigoid

Sanofi and Regeneron’s Dupixent (dupilumab) has been approved by the US Food and Drug Administration (FDA) to treat bullous pemphigoid (BP) in adults. The drug is now the only targeted medicine approved in the US to treat the chronic and relapsing skin …

FDA Clears IND for Phase 1 Study of Lonitoclax in Relapsed/Refractory AML

The FDA cleared the investigational new drug (IND) application for a phase 1 multicenter study of lonitoclax in relapsed/refractory (R/R) acute myeloid leukemia (AML). The study will evaluate the safety, feasibility, and efficacy of lonitoclax in …

Compass Plots Path to FDA With ‘Meaningful’ Phase III Data for Psilocybin Drug in Depression

Compass Pathway’s investigational psilocybin therapy COMP360 significantly eases symptoms in patients with treatment-resistant depression, clearing the way for regulatory discussions. A release from the company on Monday was light on specifics, without any …

Frozen Shrimp Market Registering at a CAGR of 8.3%, and is Projected to Reach $21.9 Billion by 2032

Increase in health consciousness, convenience & versatility, and globalization & trade liberalization are the factors that drive the growth of the market. WILMINGTON, DE, UNITED STATES, June 25, 2025 /⁨EINPresswire.com⁩/ -- Frozen shrimp …

Puerto Rico Debuts Premium Artisanal Rum Collection, Reinforcing Its Title as the Rum Capital of the World

SAN JUAN, PUERTO RICO, June 24, 2025 /⁨EINPresswire.com⁩/ -- Puerto Rico has taken a bold step forward in the evolution of its iconic rum industry with the launch of eight new artisanal brands in the U.S. market. This unprecedented expansion of …

The King of the Boogie Comes Home: John Lee Hooker’s Award-Winning Bourbon Launches in Michigan

A Hero’s Return: Family-Owned John Lee Hooker Legacy Spirits Brings Its Soulful, 14-Time Award-Winning Bourbon Back to the State That Forged a Legend DETROIT, MI, UNITED STATES, June 24, 2025 /⁨EINPresswire.com⁩/ -- DETROIT, MI – [June 24, 2025] – …

Endless Orchard Cider Wins Top Awards with Arctic® Apple Blends, Highlighting OSF’s Innovation in Value-Added Produce

Arctic® apples continue to transform what’s possible in produce and premium beverages LAKE CHELAN, WA, UNITED STATES, June 24, 2025 /⁨EINPresswire.com⁩/ -- Endless Orchard® Cider Wins National Recognition—Showcasing the Innovation of Arctic® …

The CBMAS Announce 2025 'CRUSHIE' Award Winners

CELEBRATING EXCELLENCE IN GLOBAL CRAFT BEVERAGE MARKETING FOR SIX YEARS MELVILLE, NY, UNITED STATES, June 24, 2025 /⁨EINPresswire.com⁩/ -- The Craft Beverage Marketing Awards (CBMAs), affectionately known as “The Crushies,” are proud to announce …

Wellness For Women Nutritional Health Package Helps Hundreds Achieve Sustainable Weight Loss and Transform Their Health

LONDON, SURREY, UNITED KINGDOM, June 24, 2025 /⁨EINPresswire.com⁩/ -- Women across the UK are celebrating remarkable weight loss and improved well-being thanks to a revolutionary programme developed by Wellness For Women. The company’s Bespoke …

Everiday Foods Ignites U.S. Pantries with Four Clean-Label Asian Chili Sauces

Four bold, extra-virgin olive oil–based condiments make their U.S. debut at Summer Fancy Foods Show, June 29–July 1 at Javits Center, NYC NEW YORK, NY, UNITED STATES, June 24, 2025 /⁨EINPresswire.com⁩/ -- Four bold, extra-virgin olive oil–based …

Industry Powerhouse Chris Weinberg To Host A Premier Business & Leadership Conference for Event Professionals

The Event Summit 2025 is coming to Miami this October. MIAMI, FL, UNITED STATES, June 24, 2025 /⁨EINPresswire.com⁩/ -- Renowned luxury event planner and business strategist Chris Weinberg has officially announced the launch of The Event Summit …

Made In America Warehouse Automation: Strengthening Domestic Supply Chains

Why Made in America Matters More Than Ever WIXOM, MI, UNITED STATES, June 24, 2025 /⁨EINPresswire.com⁩/ -- Integrated Systems Design (ISD), a distinguished systems integrator and OEM provider of advanced warehouse automation solutions, announces its …

Chef Karl Wilder’s Boston Terrier, Milou, Named Official Mascot of TheChefTours.com

A Brand Mascot for Food Tourism PARIS, FRANCE, June 24, 2025 /⁨EINPresswire.com⁩/ -- FOR IMMEDIATE RELEASE Contact: Karl Wilder Email: karl.wilder@thecheftours.com Website: www.thecheftours.com Chef Karl Wilder’s Boston Terrier, Milou, Named …

Ezassi Enhances Innovation Management Platform with AI-Powered Ideation Feature

Ezassi adds GPT-4 and RAG to its ideation platform, automating idea evaluation for efficient innovation while ensuring data privacy. PONTE VEDRA BEACH, FL, UNITED STATES, June 24, 2025 /⁨EINPresswire.com⁩/ -- Ezassi, a leader in innovation …

Fresh Monkee Surpasses 1.5 Million Shakes Sold, Expands to 15 States With 20 Locations and Counting

Fastest-Growing Fresh Protein Shake Brand Celebrates Explosive Growth and National Expansion WETHERSFIELD, CT, UNITED STATES, June 24, 2025 /⁨EINPresswire.com⁩/ -- Fresh Monkee, the fast-casual protein shake brand redefining what it means to eat …

Hearth, Patio & Barbecue Association Shares Insights for July's National Grilling Month

Celebrate National Grilling Month in July with HPBA insights into premium outdoor cooking trends, consumer habits, and outdoor kitchen investments. ARLINGTON, VA, UNITED STATES, June 24, 2025 /⁨EINPresswire.com⁩/ -- July marks National Grilling Month, the …

Oola Bowls® Debuts in Massachusetts with 100 Free Bowls Grand Opening Celebration in Newburyport, MA on June 28

NEWBURYPORT, MA, UNITED STATES, June 24, 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 announce the opening of …

Kate’s Real Food Launches 'Preserve Where You Play,' a Platform for Outdoor Conservation and Sustainability Education

Strategic partnerships with Wyoming State Parks and Penn State University drive conservation and education efforts in the places that grow and inspire adventure JACKSON, WY, UNITED STATES, June 24, 2025 /⁨EINPresswire.com⁩/ -- Kate’s Real Food, …

Global Dairy Processing Equipment Market Growth: Projected To Reach $19.77524 Billion By 2029 With Impressive 5.57% CAGR

The Business Research Company’s Dairy Processing Equipment Global Market Report 2025 – Market Size, Trends, And Forecast 2025-2034 LONDON, GREATER LONDON, UNITED KINGDOM, June 24, 2025 /⁨EINPresswire.com⁩/ -- The dairy processing equipment market …

Briggs Coffee Brewer Provides Affordable, Eco-Friendly Coffee Brewing Solution

Briggs Coffee Brewer aims to reduce plastic waste while keeping brewing costs low. LOS ANGELES, CA, UNITED STATES, June 24, 2025 /⁨EINPresswire.com⁩/ -- In a world where billions of cups of coffee are consumed annually, the hidden costs of the …

TONNINO BRINGS GOURMET SHELF-STABLE SEAFOOD TO CENTER STAGE AT THE SUMMER FANCY FOOD SHOW

Premium Tuna and Salmon Take the Spotlight with Bold Flavors, Gourmet Formats, and a Modern Approach to Mealtime NEW YORK, NY, UNITED STATES, June 24, 2025 /⁨EINPresswire.com⁩/ -- Tonnino, long recognized for setting the standard in gourmet tuna, …

Attention Travelers: Sovány Sparkling Water Lands at Boston Logan International Airport

Now Available at Berkshire Farms Market – The Refreshment of Summer Travel LAS VEGAS, NV, UNITED STATES, June 24, 2025 /⁨EINPresswire.com⁩/ -- Sovány, the premium organic sparkling water brand known for its vibrant flavor and clean ingredients, is now …

Whitefish Food & Wine Returns for Second Annual Festival Sept 8–14, 2025, Co-Founded by Award-Winning Chef Todd English

The premier culinary celebration of Whitefish, Montana, returns for its sophomore year with expanded lineup of chefs, wineries, and one-of-a-kind experiences. WHITEFISH , MT, UNITED STATES, June 24, 2025 /⁨EINPresswire.com⁩/ -- Whitefish Food …