FDA Newswire

HC rejects Vimal maker’s plea on FDA notices to SRK, Ajay Devgn and Tiger Shroff

The Delhi High Court on Monday dismissed a plea by Vimal Elaichi maker PB Agro LLP challenging a Maharashtra Food and Drug Administration (FDA) show-cause notice issued to actors Shah Rukh Khan, Ajay Devgn, and Tiger Shroff over the alleged surrogate …

FDA Announces Recall of Popular Cheese Sold at Whole Foods—Here’s Everything to Know

If you’ve recently picked up some soft goat cheese at Whole Foods Market, here’s an important heads-up. On September 11, the U.S. Food and Drug Administration (FDA) published a company announcement reporting that Whole Foods is recalling its Fromagerie …

Phio Announces PH-762 Milestone with FDA Submission Supporting Clinical Development in Cutaneous Squamous Cell Carcinoma

Company Proposes Planned Phase 2b Neoadjuvant Study Following Successful Completion of Phase 1b Trial Phio Pharmaceuticals Corp. (NASDAQ:PHIO) KING OF PRUSSIA, PA, UNITED STATES, September 14, 2026 /⁨EINPresswire.com⁩/ -- Phio Pharmaceuticals …

Why Delhi HC rejected Vimal Elaichi makers' plea over FDA notice to SRK, Ajay Devgn, Tiger Shroff

The Delhi high court on Monday rejected a petition by the makers of Vimal Elaichi seeking to quash show-cause notices issued by the Maharashtra food and drugs administration (FDA) to brand ambassadors Shah Rukh Khan, Ajay Devgn and Tiger Shroff. The …

Psychedelics get a hearing at FDA

FDA approves Joenja for children with APDS

September 14, 2026 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 [email protected]. Back to Healio Key takeaways: Joenja is the …

FDA Announces Recall of Popular Cheese Sold at Whole Foods in 7 States

"Hearst Magazines and AOL may earn commission or revenue on some items through these links." If you’ve recently picked up some soft goat cheese at Whole Foods Market, here’s an important heads-up. On September 11, the U.S. Food and Drug …

Piramal Pharma UK facility receives seven US FDA observations

New Delhi, Sep 14 (PTI) Piramal Pharma Limited's Morpeth facility in the UK has received seven observations after an inspection by the US Food and Drug Administration (US FDA), according to a regulatory filing. The US FDA conducted the inspection at …

<![CDATA[FDA Extends Review of Zanzalintinib Combo in Pretreated Metastatic CRC]]>

The FDA has extended its review of the new drug application (NDA) for zanzalintinib (XL092) plus atezolizumab (Tecentriq) as a treatment for patients with previously treated metastatic colorectal cancer (CRC), according to a regulatory filing from Exelixis …

<![CDATA[FDA Approves TLX101-Px for PET Imaging in Patients With Glioma]]>

The FDA has approved floretyrosine F 18 or 18F-FET (TLX101-Px; Pixclara), a radioactive diagnostic drug to be used with PET, for the characterization of recurrent or progressive glioma, according to a news release from Telix.1 The approval follows a …

<![CDATA[FDA Approves Topical Gel for Superficial Basal Cell Carcinoma ]]>

The FDA has approved aminolevulinic acid hydrochloride (Ameluz), a 10% topical gel, in combination with photodynamic therapy such as the BF-RhodoLED® lamp series for patients with superficial basal cell carcinoma, according to a press release by …

FDA Approves Reduced Monitoring Time For Amgen's First Two IMDELLTRA Doses

Amgen (AMGN) announced that the U.S. FDA has approved an update to the IMDELLTRA (tarlatamab-dlle) Prescribing Information, substantially reducing the recommended monitoring time for the first two doses of treatment in an appropriate healthcare setting. …

Operation against encroachments starts in residential colonies, markets: FDA

FAISALABAD, Sep 14 (APP):On the directives of Director General Faisalabad Development Authority (FDA) Muhammad Asif Chaudhary, a vigorous operation against encroachments is underway in residential colonies and commercial markets under the administrative …

FDA to hold public hearing on psychedelic drugs as Trump-driven push gathers pace

By Puyaan Singh and Kamal Choudhury Sept 14 (Reuters) – The U.S. Food and Drug Administration will hold a public hearing on Monday to gather feedback on the potential therapeutic use of psychedelic drugs, the latest step in a months-long push by President …

FDA OKs First Drug to Target Muscle Loss in SMA

The FDA has approved the first therapy for spinal muscular atrophy (SMA) that directly targets muscle loss, providing a complementary approach to existing treatments that target motor neuron survival. Apitegromab-mstn (Isembyld, Scholar Rock) is approved …

FDA Clears Beta Bionics' Mint Insulin Patch Pump for Diabetes

The US Food and Drug Administration (FDA) has cleared Mint, the insulin patch pump developed by Beta Bionics, clearing the way for full US commercialization in the first quarter of 2027.1 Frequently Asked Questions What is Mint approved for? The FDA has …

FDA APPROVES REDUCED MONITORING TIME FOR FIRST TWO DOSES OF IMDELLTRA®

Update Supports Broader Access to IMDELLTRA in Community Settings for People Living with Extensive-Stage Small Cell Lung Cancer Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) approved an update to the IMDELLTRA® ( …

FDA Priority Review Granted to Zasocitinib for Moderate to Severe Psoriasis

Frequently Asked Questions: What is zasocitinib being evaluated for? Zasocitinib is under FDA priority review for adults with moderate-to-severe plaque psoriasis, based on phase 3 data from the LATITUDE PsO program. How does zasocitinib work? Zasocitinib …

Ameluz Treatment Becomes First FDA-Approved PDT for Skin Cancer

Frequently Asked Questions: What is Ameluz now approved to treat? Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, used with the BF-RhodoLED lamp series, is FDA approved for actinic keratosis and, as of this approval, superficial basal cell …

Integrated R&D & Manufacturing: Kacise Builds Water Quality Sensor Brand Moat with Multi-Parameter & Global Reach

Integrating R&D, manufacturing and sales, specializing in water quality monitoring sensors, ultrasonic level sensors, capacitive and radar level sensors. CALIFORNIA, CA, UNITED STATES, September 15, 2026 /⁨EINPresswire.com⁩/ -- XI'AN, China — XI…

Top Canned Fruit Manufacturer Expands Reliable Fruit Processing Solutions

HANGZHOU, ZHEJIANG, CHINA, September 15, 2026 /⁨EINPresswire.com⁩/ -- As demand for convenient, shelf-stable fruit products continues to grow across international food markets, manufacturers are placing greater emphasis on ingredient quality, …

韩国食品包装企业SEIL扩大纸质与纸浆容器产品开发

SOUTH KOREA, September 15, 2026 /⁨EINPresswire.com⁩/ -- 随着外卖、即食食品和餐饮服务方式不断变化，食品包装企业开始采用更多元的材料和容器结构 韩国京畿道 — 随着外卖、即食食品和餐饮服务的发展，食品包装的使用场景正在不断增加。韩国食品包装企业 SEIL Co., Ltd. 近年来持续开发纸质、纸浆以及多种塑料材质的食品容器，以适应不同食品和流通环境的包装需求。 SEIL …

Revolution Barbecue’s Fuego Vida Earns Second Place at 2026 Artisan Flave Awards

Fuego Vida XXX Hot Seasoning earns another national honor after taking First Place at the 2025 Spicy Flave Awards. THORNTON, CO, UNITED STATES, September 14, 2026 /⁨EINPresswire.com⁩/ -- Revolution Barbecue, a Colorado-made, woman-owned and family- …

How COPAK Is Advancing PET Cups Through Food-Grade Quality and Customization

SHANGHAI, SHANGHAI, CHINA, September 15, 2026 /⁨EINPresswire.com⁩/ -- As beverage brands continue to seek packaging that combines food safety, visual appeal, durability, and flexible branding, PET Cups are becoming an increasingly important option for cold …

MOPE Clinic Issues Louisiana Tip Sheet on Preserving Lean Mass During Significant Weight Loss

Metairie clinic highlights current research on muscle preservation, nutrition, resistance training and body composition during weight loss. METAIRIE, LA, UNITED STATES, September 14, 2026 /⁨EINPresswire.com⁩/ -- MOPE Clinic, a physical medical …

Five Reputable Electric Grill Manufacturers in 2026: Driving Smart Outdoor Cooking Innovation

A Look at How Leading Brands Are Advancing Temperature Control and Energy Efficiency CALIFORNIA, CA, UNITED STATES, September 14, 2026 /⁨EINPresswire.com⁩/ -- YUYAO, ZHEJIANG PROVINCE, CHINA — SEPTEMBER 15, 2026 | MANUFACTURING & TRADE | LIGHT …

HLRB Processing Goes Live with AC2 WAVE WMS to Improve Real-Time Inventory Visibility and Traceability

New system helps Halal poultry processor reduce inventory information retrieval from more than three days to under three seconds. MELAKA, MALAYSIA, September 15, 2026 /⁨EINPresswire.com⁩/ -- HLRB Processing has successfully gone live with AC2 WAVE WMS, …

With the Fed Holding Firm, Stan Rutstein Says Q4 Is the Sarasota–Manatee Market's Best Window of the Year

As season returns and year-end nears, Rutstein says Q4 rewards those who act now rather than wait on cheaper money. BRADENTON, FL, UNITED STATES, September 14, 2026 /⁨EINPresswire.com⁩/ -- As the calendar turns toward the fourth quarter, Stan …

DAVE & BUSTER’S NOW HIRING IN COLLEGE STATION

College Station welcomes the ultimate entertainment and restaurant destination this October COLLEGE STATION, TX, UNITED STATES, September 14, 2026 /⁨EINPresswire.com⁩/ -- Dave & Buster's, the premier destination for entertainment, dining, …

inBeat Agency Marks Eight Years of Creator-Led Performance Marketing

NEW YORK, NY, UNITED STATES, September 14, 2026 /⁨EINPresswire.com⁩/ -- NEW YORK, NY — inBeat Agency is marking eight years in business with a renewed focus on helping consumer brands turn creator content into a more accountable part of their …

Cabo.Luxury Launches New Website for Private Villa Rentals in Los Cabos

LOS ANGELES, CA, UNITED STATES, September 14, 2026 /⁨EINPresswire.com⁩/ -- Cabo.Luxury, a new website for private villa stays, brings together properties in Palmilla, Pedregal, Puerto Los Cabos, Cabo San Lucas, San Jose del Cabo, the Los Cabos …

Wise Hustlers Technologies Pvt Ltd Delivers Successful Multi-Surface Loyalty Platform for Pointfinity

US-focused loyalty platform: Wise Hustlers built a customer app, store portal, and admin panel on shared engine - while keeping payments entirely off-platform. CHICAGO RIDGE, IL, UNITED STATES, September 14, 2026 /⁨EINPresswire.com⁩/ -- Wise Hustlers …

Palestinian Wine in Britain: Nabeeth brings Palestine's winemaking and Indigenous grapes to the UK

Nabeeth is bringing wines, indigenous grapes and brewing heritage to Britain's restaurants, wine shops and homes. LONDON, UNITED KINGDOM, September 14, 2026 /⁨EINPresswire.com⁩/ -- Palestinian Wine in Britain: Nabeeth Brings Palestine’s …

Rarebird Becomes NEUCAFF Performance Coffee, Betting the Future of Performance Starts With Coffee

Rebrand pairs specialty coffee with paraxanthine as consumers look beyond traditional caffeine for energy and focus SAN FRANCISCO, CA, UNITED STATES, September 14, 2026 /⁨EINPresswire.com⁩/ -- Rarebird, the coffee company that introduced consumers to …

Eight Years Strong: Creole Food Fest Hits Brooklyn Bridge Park October 3rd

A celebration of Creole cuisine spanning the Caribbean, the Americas, and Africa presented with Time Out Market to elevate diverse culinary voices. BROOKLYN, NY, UNITED STATES, September 14, 2026 /⁨EINPresswire.com⁩/ -- Creole Food Fest, the …

Cheesecake Funk Celebrates One Year With Visit From Legends Jimmy Jam & Terry Lewis

A Prince-inspired Minnesota business story comes full circle as Cheesecake Funk celebrates its first anniversary in Excelsior, MN. EXCELSIOR, MN, UNITED STATES, September 14, 2026 /⁨EINPresswire.com⁩/ -- What started with a cheesecake in the refrigerator …

Epos Now Launches Countertop 2 Point of Sale in the US

The Countertop 2 is 3x faster than previous solutions, meaning lines move, tables turn and staff spend less time waiting on screens and more time with customers ORLANDO, FL, UNITED STATES, September 14, 2026 /⁨EINPresswire.com⁩/ -- Epos Now …

Next Employment Expands Staffing Services With Pre-Placement Training Across Canada

Candidates complete food safety, chemical handling, accessibility and workplace safety training before placement across twelve staffing sectors. MISSISSAUGA, ONTARIO, CANADA, September 14, 2026 /⁨EINPresswire.com⁩/ -- Next Employment has expanded its …

Peirano Estate Winery Earns Three New 90+ Point Wine Enthusiast Honors

LODI, CA, UNITED STATES, September 14, 2026 /⁨EINPresswire.com⁩/ -- Peirano Estate Winery has added three more 90+ point ratings to its growing list of critical acclaim, with Wine Enthusiast Magazine recognizing three of the winery's latest …