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Published on 14:55 GMT

A Looming FDA Decision, Approval Odds, Investor Takeaways

Late-stage biopharma Scholar Rock (SRRK) is approaching a pivotal catalyst: the FDA decision on apitegromab, its investigational muscle-targeted therapy for spinal muscular atrophy (SMA). A verdict is expected on September 22, and the company appears well- …

Source: Forbes - Neutral
Published on 05:59 GMT

Incyte Announces Additional FDA Approval of Opzelura® Cream in Children Ages 2-11 with Atopic Dermatitis

Opzelura is the first topical JAK inhibitor approved in the U.S. for pediatric atopic dermatitis (AD) Phase 3 data supporting the approval show that treatment with Opzelura resulted in significant efficacy, with no new safety concerns identified This …

Source: Investing News Network - Neutral
Published on 14:52 GMT

FDA proposes ban on obsolete food dye Orange B

USA – Federal regulators are moving to eliminate another artificial dye from the U.S. food supply, this time targeting Orange B, a synthetic color additive that has not been used in decades. The U.S. Food and Drug Administration (FDA) recently announced …

Source: Food Business Africa Magazine - Pending
Published on 14:20 GMT

Replimune Group (REPL) Nosedives 39% as FDA Approval for Melanoma Treatment ‘Uncertain’

We recently published 10 Stocks Losing Big Amid Market Boom. Replimune Group, Inc. (NASDAQ:REPL) is one of the best performers on Thursday. Replimune extended losses to a second consecutive day on Thursday, slashing 39.40 percent to close at $3.46 apiece …

Source: Yahoo Finance - Center-left
Published on 11:58 GMT

Minovia Therapeutics’ MNV-201 Granted FDA Fast Track Designation for Myelodysplastic Syndrome

Minovia Therapeutics Ltd., a clinical-stage biotech focused on mitochondrial diseases and age-related conditions, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its lead investigational drug, MNV- …

Source: Pharma Journalist - Neutral
Published on 14:52 GMT

BENEO secures Thai FDA approval for exclusive prebiotic claim on its chicory root fibre

THAILAND – BENEO, a leading global manufacturer of functional ingredients for food, feed, and pharmaceuticals, has achieved a major milestone with the Thai Food and Drug Administration (FDA) granting exclusive approval for a prebiotic claim on its chicory …

Source: Food Business Africa Magazine - Pending
Published on 12:47 GMT

FDA Expands Incyte's Opzelura Approval To Treat Atopic Dermatitis In Children

The U.S. Food and Drug Administration (FDA) on Thursday approved Incyte Corporation’s INCY announced Opzelura (ruxolitinib) cream 1.5% for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non- …

Source: Benzinga - Neutral
Published on 14:37 GMT

FDA Warns About Cookware That Could Leach Toxic Chemical Into Your Food

The Food and Drug Administration (FDA) has issued an urgent warning about certain nonstick cookware potentially leaching significant levels of lead into food. Initially announced on August 13, 2025, the FDA updated the warning on September 12, adding three …

Source: News Radio 610 WTVN - Pending
Published on 14:48 GMT

FDA should prioritize oversight of widely used food additives rather than abandoned ones

Sept. 19, 2025 7 AM PT To the editor: The Food and Drug Administration’s proposal to formally ban Orange B, a synthetic food dye not used for decades, may seem largely symbolic (“FDA proposes ban on Orange B, a food dye not used for decades,” Sept. 17), …

Source: Los Angeles Times - Center-left
Published on 11:03 GMT

Indoco’s API facility at Patalganga completes US FDA inspection with zero observations

Indoco Remedies, a fully integrated, research-oriented pharmaceutical company, has announced that the United States Food and Drug Administration (FDA) successfully completed inspection of its active pharmaceutical ingredients (API) manufacturing facility …

Source: Pharmabiz.com - Neutral
Published on 14:09 GMT

Ruthless Spine wins FDA clearance, patent approval for spinal navigation device

Ruthless Spine said it has received U.S. Food and Drug Administration 510(k) clearance for its NavJam Jamshidi device, alongside a newly allowed U.S. patent application, marking a milestone in the company’s effort to reshape spinal screw placement …

Source: Medical Economics - Neutral
Published on 09:34 GMT

FDA nicotine pouch pilot to ease manufacturers' research burden - report

AndreyPopov/iStock via Getty ImagesThe U.S. Food and Drug Administration will ease requirements on nicotine pouch manufacturers under a new pilot program, Reuters reported on Friday, citing internal meeting transcripts. The FDA looks to ensure products …

Source: Markets Insider - Neutral
Published on 14:09 GMT

Medtronic wins FDA approval for new tibial neuromodulation device

Medtronic plc announced that the U.S. Food and Drug Administration has approved its Altaviva implantable tibial neuromodulation (ITNM) device, a minimally invasive therapy for patients with urge urinary incontinence. The device, implanted near the ankle, …

Source: Medical Economics - Neutral
Published on 12:50 GMT

Brainlab unveils FDA-approved spine mixed reality navigation in US

Digital medical technology company Brainlab has announced 510(k) clearance for its Spine Mixed Reality Navigation by the Food and Drug Administration, marking the system’s official launch in the US. This surgical navigation tool provides mixed reality …

Source: Medical Device Network - Neutral
Published on 14:00 GMT

3 FDA approval firsts that could be around the corner

The industry’s final months of 2025 could be action-packed as the FDA renders approval decisions on drugs that would be groundbreaking in their indications. For some of pharma’s largest drugmakers, upcoming PDUFA dates could pave the way for new …

Source: PharmaVoice - Neutral
Published on 14:52 GMT

FDA Approves Ruxolitinib Cream for Atopic Dermatitis in Children 2 Years and Older

The FDA approved ruxolitinib (Opzelura) cream 1.5% for the short-term and noncontinuous chronic treatment of mild to moderate atopic dermatitis (AD) in nonimmunocompromised children 2 years and older whose disease is inadequately controlled with topical …

Source: Drug Topics - Neutral
Published on 14:38 GMT

FDA updates Airsupra prescribing information in mild asthma

September 19, 2025 2 min read Add topic to email alerts Subscribe We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Key takeaways: The risk for …

Source: Healio News - Neutral
Published on 14:16 GMT

Medtronic gets FDA nod for implantable neuromod for urinary incontinence

Medtronic (NYSE: MDT) + announced today that it received FDA approval for its Altaviva neuromodulation device. Atlaviva, a minimally invasive implantable tibial neuromodulation (ITNM) device, is inserted near the ankle and designed to treat urge urinary …

Source: MassDevice - Neutral
Published on 05:23 GMT

FDA threatens to eliminate natural thyroid treatment

A recent announcement by the Food and Drug Administration about natural thyroid treatment has readers of this newspaper column up in arms. Nearly 5% of American adults have a thyroid gland that doesn’t function well (hypothyroidism). The treatment supplies …

Source: The Vindicator - Ohio - Pending

03 days 11:20:38

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Published on September 19, 2025 - 12:15 GMT

Polyrizon Submits Pre-Sub Package to the FDA for PL-14 Allergy Blocker

Ra’anana, Israel, Sept. 19, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a biotechnology company focusing on the development of intranasal products, today announced the submission of its full pre-submission (Pre- …

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Published on September 18, 2025 - 22:37 GMT

FDA vacates final rule regulating lab-developed tests as medical devices

The Food and Drug Administration released a final rule Sept. 18 that rescinds one from 2024 that applied medical device rules to laboratory-developed tests. The final rule is in response to a March 31 federal district court decision that also vacated the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 19, 2025 - 15:27 GMT

Vaccines and Related Biological Products Advisory Committee October 9, 2025 Meeting Announcement - 10/09/2025

Date: October 9, 2025 Time: 8:30 a.m. - 6:00 p.m. ET What is an advisory committee? Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 19, 2025 - 13:00 GMT

REPL 3-DAY DEADLINE ALERT: Replimune (REPL) Shares Tank 45% After Company Says No Pathway Identified For Lead Drug RP1, ...

SAN FRANCISCO, Sept. 19, 2025 (GLOBE NEWSWIRE) -- On September 18, 2025, investors in Replimune Group, Inc. (NASDAQ: REPL) saw the price of their shares crater about 45% during intraday trading after the company announced that it completed a Type A meeting …

Distribution channels: Consumer Goods, Law ...

Published on September 19, 2025 - 13:50 GMT

Spectrum Pharmaceuticals (SPPI) and Assertio Holdings (ASRT) Investor Alert: 6-DAY DEADLINE in Securities Lawsuit – ...

SAN FRANCISCO, Sept. 19, 2025 (GLOBE NEWSWIRE) -- A New York federal court has re-opened the lead plaintiff process in the Spectrum Pharmaceuticals (SPPI) securities class action. This development offers a new opportunity for investors to represent the …

Distribution channels: Consumer Goods, Law ...
Published on September 19, 2025 - 12:00 GMT

Esperion Partner Otsuka Receives Regulatory Approval to Market NEXLETOL® in Japan for the Treatment of ...

ANN ARBOR, Mich., Sept. 19, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that Otsuka Pharmaceutical Co., Ltd. (Otsuka), the Company’s partner for the development and commercialization of NEXLETOL® (bempedoic acid) tablets in Japan, has …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on September 19, 2025 - 12:00 GMT

Iterum Therapeutics Provides Business Update

DUBLIN and CHICAGO, Sept. 19, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a company focused on delivering next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community …

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Published on September 18, 2025 - 18:29 GMT

FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025

Retailers Should Not Sell and Consumers Should Not Use Certain Cookware Because of Their Potential to Leach Lead into Food When Cooking AUDIENCE: Consumer, Health Care Professional, Pediatrics, Family Practice, Neurology ISSUE: The FDA is warning retailers …

Distribution channels: Healthcare & Pharmaceuticals Industry

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Food & Beverage Industry Press Releases

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Published on September 19, 2025 - 16:12 GMT

Bon Soir Caterers Announces Heritage‑Driven Fusion Menus—Leading a Trend Among New York City Wedding Caterers

Bon Soir Caterers launches heritage-driven fusion wedding menus in NYC, blending cultural traditions into personalized dining experiences for couples. BROOKLYN, NY, UNITED STATES, September 19, 2025 /⁨EINPresswire.com⁩/ -- Bon Soir Caterers, a full- …

Distribution channels: Food & Beverage Industry ...
Published on September 19, 2025 - 15:53 GMT

The Sweet Wheels Co. Elevates Corporate Cart Rental with Sensory Marketing and Flavor-Branded Menus

The Sweet Wheels Co. launches flavor-branded cart rentals, aligning taste, scent, and design with corporate events across NY, NJ, and CT. NY, UNITED STATES, September 19, 2025 /⁨EINPresswire.com⁩/ -- The Sweet Wheels Co., a premium concessions …

Distribution channels: Business & Economy, Companies ...
Published on September 19, 2025 - 15:43 GMT

U.S. & Japan Collagen Supplements Market Set to Reach $1.6 Billion by 2030, With a Sustainable CAGR Of 7.4%

Rise in the adoption of an inactive or deskbound lifestyle, growing demand for good-for-you products, expansion of retail market drive the growth of the market. WILMINGTON, DE, UNITED STATES, September 19, 2025 /⁨EINPresswire.com⁩/ -- U.S. & …

Distribution channels: Food & Beverage Industry, Healthcare & Pharmaceuticals Industry ...
Published on September 19, 2025 - 14:51 GMT

High Oleic Sunflower Oil: The Rising Star of the U.S. Edible Oils Market

From Commodity GMO oils to Healthy and effectiveness High oleic sunflower oil CHICAGO, IL, UNITED STATES, September 19, 2025 /⁨EINPresswire.com⁩/ -- In the evolving U.S. food industry, consumer demand for healthier, more sustainable, and versatile oils …

Distribution channels: Beauty & Hair Care, Consumer Goods ...
Published on September 19, 2025 - 14:00 GMT

Old Trapper Expands NFL Network Sponsorship with Good Morning Football Renewal and GameDay Preview Presenting Role

FOREST GROVE, OR, UNITED STATES, September 19, 2025 /⁨EINPresswire.com⁩/ -- Old Trapper today announced that the beef jerky and meat snacks brand is the presenting sponsor of NFL Network’s Emmy Award-winning Good Morning Football for the fifth …

Distribution channels: Companies, Consumer Goods ...
Published on September 19, 2025 - 14:00 GMT

Juici Patties Brings Authentic Jamaican Flavors to Queens, NY with First & Only Location in the Borough

113-17 Sutphin Blvd celebrates Jamaica’s iconic patty with serious flavor, culture, and community QUEENS, NY, UNITED STATES, September 19, 2025 /⁨EINPresswire.com⁩/ -- Jamaica’s beloved patty brand, Juici Patties, has officially opened its first …

Distribution channels: Food & Beverage Industry ...
Published on September 19, 2025 - 13:35 GMT

Global Dietary Fibers Market to Grow by 2031, Reaching USD 12.2 Bn at 8.5% CAGR Driven by Health Trends

Rising demand for functional foods, chronic disease prevention, and gut health awareness propel strong growth in the global dietary fibers market. AUSTIN, TX, UNITED STATES, September 19, 2025 /⁨EINPresswire.com⁩/ -- The global dietary fibers …

Distribution channels: Food & Beverage Industry ...
Published on September 19, 2025 - 12:51 GMT

China Smart Packaging Industry Set for Growth: Yiruixing Packaging Shapes the Future of Market Innovation in China

FO SHAN SHI, GUANG DONG SHENG, CHINA, September 19, 2025 /⁨EINPresswire.com⁩/ -- In China, packaging is evolving quickly, moving well beyond a basic job of product protection. The arrival of new technologies and higher consumer expectations is …

Distribution channels: Beauty & Hair Care, Consumer Goods ...
Published on September 19, 2025 - 12:30 GMT

Jam Vino Wine-Infused Gourmet Jam Featured at the 2025 Pre-Emmys Celebrity Gifting Lounge in Hollywood

A true culinary innovation, Jam Vino has become a gourmet favorite among A-list celebrities for its rich, fine wine flavor profile without the alcohol content. LOS ANGELES, CA, UNITED STATES, September 19, 2025 /⁨EINPresswire.com⁩/ -- Jam Vino, …

Distribution channels: Food & Beverage Industry ...
Published on September 19, 2025 - 12:21 GMT

Beer Market Size to Worth USD 1,167.47 Billion by 2032 | CAGR of 4.07% during 2025-2032

The beer industry report covers key companies such as Carlsberg A/S (Denmark), Diageo Plc (U.K.), Molson Coors Beverage Company (U.S.), and Others. NY, UNITED STATES, September 19, 2025 /⁨EINPresswire.com⁩/ -- Market Overview: The global beer market size …

Distribution channels: Food & Beverage Industry ...
Published on September 19, 2025 - 12:21 GMT

Sake Market Size to Worth USD 12.65 Billion by 2032 | CAGR of 4.08% during 2025-2032

The sake market report covers key companies such as Takara Holdings Inc., Ozeki Sake, Asahishuzo CO., Ltd., Tatsuuma-Honke Brewing Co. Ltd., and Others. NY, UNITED STATES, September 19, 2025 /⁨EINPresswire.com⁩/ -- Report Overview: The global …

Distribution channels: Food & Beverage Industry ...
Published on September 19, 2025 - 12:19 GMT

Avocado Oil Market Size to Worth USD 1,134.81 million by 2032 | CAGR of 7.48% during 2024-2032

The avocado oil market report covers key companies such as La Tourangelle, Inc. (California, U.S.), Proteco Gold Pty Ltd. (Queensland, Australia), and Others. NEW YORK, NY, UNITED STATES, September 19, 2025 /⁨EINPresswire.com⁩/ -- Market Overview- …

Distribution channels: Food & Beverage Industry ...
Published on September 19, 2025 - 11:48 GMT

Catechin Market Size, Share, Competitive Landscape, Trend Analysis and Industry Forecast

Increase in demand for natural and organic products, surge in health awareness, and rise in prevalence of obesity and diabetes drive the growth of the market. WILMINGTON, DE, UNITED STATES, September 19, 2025 /⁨EINPresswire.com⁩/ -- Catechin …

Distribution channels: Food & Beverage Industry, Healthcare & Pharmaceuticals Industry ...
Published on September 19, 2025 - 09:33 GMT

Food Service Feta Cheese Market Set to Reach $3,816.8 Million by 2030, With a Sustainable CAGR Of 6.9%

Expansion of the food & beverages industry, health benefits provided by feta cheese, and shift in the food consumption behavior drive the growth of the market. WILMINGTON, DE, UNITED STATES, September 19, 2025 /⁨EINPresswire.com⁩/ -- Food …

Distribution channels: Business & Economy, Food & Beverage Industry ...
Published on September 19, 2025 - 09:25 GMT

Vegan Steak Market Size to Reach USD 5.99 Billion by 2034, Growing at 14.78% CAGR

The global vegan steak market size was worth around USD 1.99 billion in 2024 and is predicted to grow to around USD 5.99 billion by 2034 PUNE, MAHARASHTRA, INDIA, September 19, 2025 /⁨EINPresswire.com⁩/ -- The global vegan steak market Size is …

Distribution channels: Food & Beverage Industry ...
Published on September 19, 2025 - 08:23 GMT

Refrigerated Snacks Market Growing at 5.6% CAGR to Generate $165.4 Billion by 2030

Rapid growth of food services industry, increase in adoption of convenience food with rising inclination toward sedentary life style & emergence of clean label. WILMINGTON, DE, UNITED STATES, September 19, 2025 /⁨EINPresswire.com⁩/ -- …

Distribution channels: Business & Economy, Food & Beverage Industry ...
Published on September 19, 2025 - 08:07 GMT

Coffee Substitutes Market Size Expected to Hit US$ 22 Billion by 2035, Exhibiting 4.2% CAGR: Fact.MR Analysis

Health-conscious consumers drive growth in the coffee substitutes market as demand rises for caffeine-free, functional, and sustainable beverages. ROCKVILLE, MD, UNITED STATES, September 19, 2025 /⁨EINPresswire.com⁩/ -- The coffee substitutes …

Distribution channels: Food & Beverage Industry ...
Published on September 19, 2025 - 07:32 GMT

Cashew Milk Market Size Expected to Reach $154.9 Million by 2032: Nutty life, Cashew Dream, Danone SA

The cashew milk market size was valued at $61.9 million in 2022, and is estimated to reach $154.9 million by 2032, growing at a CAGR of 10.1% DE, UNITED STATES, September 19, 2025 /⁨EINPresswire.com⁩/ -- As more individuals become health- …

Distribution channels: Business & Economy, Food & Beverage Industry ...
Published on September 19, 2025 - 07:12 GMT

Nong Li by China Resources Snow Breweries Wins Platinum in A' Packaging Design Awards

China Resources Snow Breweries' Nong Li Beer Packaging Recognized for Excellence in Packaging Design with Prestigious A' Design Award COMO, CO, ITALY, September 19, 2025 /⁨EINPresswire.com⁩/ -- China Resources Snow Breweries has been …

Distribution channels: Consumer Goods, Culture, Society & Lifestyle ...
Published on September 19, 2025 - 07:12 GMT

Xijiu Matured Liquor by Chengdu Times Fashion Art Design Co., Ltd Wins Platinum in A' Packaging Design Award

Innovative Packaging Design for Xijiu Matured Liquor Series Receives Prestigious International Recognition COMO, CO, ITALY, September 19, 2025 /⁨EINPresswire.com⁩/ -- The A' Design Award, a highly respected and well-recognized award in the …

Distribution channels: Consumer Goods, Culture, Society & Lifestyle ...