Serbia and Montenegro FDA Newswire

Q3 2025: 10 FDA Decisions to Watch in the Realm of Oncology

As the second quarter of 2025 closes, the pace of oncology innovation shows no signs of slowing. Recent FDA approvals have reinforced the shift toward more targeted, immunologically driven, and personalized therapies across a broad spectrum of cancers. …

FDA Indicates AdComm Not Currently Required for Capricor’s BLA for DMD Cardiomyopathy Cell Therapy Deramiocel

The FDA has indicated an advisory committee (AdComm) meeting regarding the biologics license application (BLA) for Capricor Therapeutics’ Deramiocel (also known as CAP-1002), an investigational allogeneic cardiosphere-derived cell therapy under review for …

New generic drug for skin infections is approved by the FDA

Officials for the FDA have approved a generic drug for the treatment of canine and feline skin infections. Cefovecin Sodium for Injection is sponsored by Qilu Animal Health Products Co. in Shandong, China.1 Cefovecin Sodium for Injection is an …

FDA Approves At-Home Belimumab Autoinjector for Pediatric Lupus Nephritis

The FDA has approved the 200 mg/mL autoinjector formulation of belimumab (Benlysta; GSK) for subcutaneous use in pediatric patients 5 years and older with active lupus nephritis, expanding treatment options for children living with this serious …

FDA Skips Advisory Committee For Capricor's Duchenne Cell Therapy

Capricor Therapeutics Inc CAPR on Tuesday provided regulatory updates related to its Biologics License Application (BLA) for Deramiocel, the company’s lead cell therapy candidate for the treatment of Duchenne Muscular Dystrophy (DMD)—associated …

FDA Greenlights Expanded Indication for Vizamyl in Alzheimer Disease Diagnosis

The FDA has approved an expanded indication on GE Healthcare’s PET imaging agent Vizamyl to include both quantification of amyloid burden for patients with suspected Alzheimer disease (AD) and use in therapy monitoring. With the expanded indication, …

Tissum wins FDA nod for polymer platform for sutureless nerve repair

The Tissium Coaptium Connect for sutureless nerve repair. [Image courtesy of investor Cathay Health] Tissium announced today that it received FDA de novo marketing authorization for Coaptium Connect with Tissium Light. The Paris-based company, which has …

The FDA Is Begging Americans to Stop Buying Gas Station Heroin

It’s always fun to take a gander at the odd collection of “health supplements” being sold at your local gas station, either by the counter or tucked away in a darkened corner aisle where someone was shot once. Only there will you find the choicest …

FDA, EMA Grant Lu AG13909 Orphan Drug Status for Treatment of Congenital Adrenal Hyperplasia

Lundbeck's novel humanized monoclonal antibody Lu AG13909 has received orphan drug designation from both the FDA and European Medicines Agency for the treatment of congenital adrenal hyperplasia (CAH), a rare autosomal recessive disorder affecting …

AI Spine Assistant Software Tool Receives FDA Clearance

June 24, 2025 —Smart Soft Healthcare has announced that CoLumbo, the company's advanced AI spine assistant, has received FDA 510(K) clearance for its latest version, Version 3. This achievement marks a significant milestone in CoLumbo's commitment …

BIO2025 Recap: FDA Reducing Animal Testing, Governor Shapiro On Supporting Biopharma, Practical AI Use

By Tyler Menichiello, Chief Editor, Bioprocess Online June 16 marked the beginning of this year’s BIO International Convention in Boston — a multiday gathering of the brightest minds and stakeholders from across the biotech world. Founders, CEOs, CSOs, …

Belimumab Autoinjector Receives FDA Approval for Children With Active Lupus Nephritis

The FDA approved an autoinjector of belimumab (Benlysta; GSK) for the subcutaneous injection in children aged 5 years and older with active lupus nephritis (LN) who are receiving standard therapy. This 200 mg/mL autoinjector was also approved for …

Device that uses biodegradable polymers to repair peripheral nerves gets FDA clearance

“This approval is really a game-changer for patients with peripheral nerve injuries,” said Jeffrey Karp, a Tissium co-founder who developed the device’s technology. “For the first time, surgeons now have a sutureless, bio-inspired option that can really …

Archeus Technologies Gets FDA Clearance for ART-101 Prostate Cancer Trial

Archeus Technologies announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ART-101, a novel receptor-based targeting small molecule that Archeus has developed for the imaging and treatment …

Gland Pharma facility in Vizag recieves EIR from U.S. FDA

Gland Pharma’s facility in Visakhapatnam, which was earlier this year issued Form 483 with three observations by the U.S. Food and Drug Administration, has since received an establishment inspection report from the agency, the generic injectable focussed …

FDA hires former FDA scientist Michael Davis as CDER deputy director

FDA says it's investigating Sarepta’s Duchenne patient deaths

FDA approves biannual HIV prevention shot

Sources: FDA chief Makary sought rejection of KalVista's drug

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 …