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Published on Apr 11, 2025

Cipla’s generic drug for cancer gets U.S. FDA nod

Cipla’s abbreviated new drug application for a generic version of Bristol Myers Squibb’s cancer drug Abraxane has received final approval from the U.S. Food and Drug Administration. The final approval for Paclitaxel Protein-bound Particles for Injectable …

Source: The Hindu - Center-left
Published on Apr 11, 2025

FDA plans to phase out animal testing for some drugs

Dive Brief: The Food and Drug Administration aims to phase out animal toxicology testing for experimental drugs, announcing Thursday a plan to reduce, revise or replace such requirements in favor of newer methods that are more “human relevant.” The agency …

Source: BioPharma Dive - Label Pending
Published on Apr 11, 2025

Xolair Rival Aims for Food Allergy Dosing of Every 2 to 3 Months

A San Francisco-based biotech company is developing a new blocker of the IgE allergy antibody for treating food allergies. Rapt Therapeutics says that, if it proves successful, this therapy will only require an injectable dose every two or three months. A …

Source: Allergic Living - Neutral
Published on Apr 11, 2025

‘Paradigm shift’: FDA plans to phase out animal testing in drugs

“For too long, drug manufacturers have performed additional animal testing of drugs that have data in broad human use internationally. This initiative marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments …

Source: The Boston Globe - Massachusetts - Neutral
Published on Apr 11, 2025

FDA unveils plan to replace animal testing with organoids

Newly-installed FDA Commissioner Marty Makary announced a plan to begin phasing out animal testing in drug development, particularly for monoclonal antibodies. How long that takes … Sign up to read this article for free. Get free …

Source: Endpoints News - Neutral
Published on Apr 11, 2025

FDA Grants IDE to Electrosurgical Device For Breast-Conservation Surgery

The FDA has approved the Investigational Device Exemption application for the SIRA™ RFA Electrosurgical Device in patients with breast cancer undergoing breast-conservation surgery, opening a path for the launch of a US feasibility study, according to a …

Source: Cancer Network - New Jersey - Label Pending
Published on Apr 11, 2025

FDA Grants Fast Track Designation for Potential Bird Flu Vaccine

The FDA granted fast track designation for a self-amplifying mRNA vaccine candidate (ARCT-2304) for active immunization to protect against influenza A H5N1 subtype, also known as bird flu. The designation addresses the unmet need for prevention of H5N1, …

Source: Drug Topics - Neutral
Published on Apr 11, 2025

FDA Approves Subcutaneous Vyvgart Hytrulo for Generalized Myasthenia Gravis

The FDA approved a self-injectable efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) as a prefilled syringe for the treatment of adults with generalized myasthenia gravis (MG) who are anti-acetylcholine receptor antibody positive and for adults …

Source: Drug Topics - Neutral
Published on Apr 11, 2025

FDA Approves Nonopioid Pain Medication in Novel Class for Treatment of Acute Pain

On January 30, 2023, the FDA approved suzetrigine (Journavx), a first-in-class nonopioid analgesic, for managing moderate to severe acute pain in adults. Suzetrigine, preclinically characterized as VX-548, is a highly selective inhibitor of the voltage- …

Source: Drug Topics - Neutral
Published on Apr 11, 2025

FDA Approves Self-Injection Therapy for Generalized Myasthenia Gravis and Chronic Inflammatory Demyelinating ...

Halozyme Therapeutics, Inc. announced that argenx has received FDA approval of VYVGART® Hytrulo prefilled syringe for self-injection (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG) who …

Source: American Pharmaceutical Review - Neutral
Published on Apr 11, 2025

FDA Phase Out of Animal Test Requirements for Drugs Begins With Biologics

Well before a human receives the first dose of an experimental drug, it’s evaluated in an animal to test for toxicity. Monkeys are often chosen for their genetic similarities to humans, and safe results in this preclinical research can clear the way for a …

Source: MedCity News - Neutral
Published on Apr 11, 2025

District Court Strikes Down FDA’s LDT Rule, Opens the Door for Challenges to FDA’s Regulation of Other “Services” as ...

On Monday, March 31, a court in the Eastern District of Texas found unlawful and vacated the Food and Drug Administration’s 2024 Rule regulating as “devices” under the Food, Drug, and Cosmetic Act (“FDCA”), certain laboratory-developed test (“LDTs”) used …

Source: National Law Review - Neutral
Published on Apr 11, 2025

After Hetlioz’s rejection in jet lag disorder, Vanda sues FDA for right to promote off-label use

After years of back-and-forth with the FDA over Hetlioz's potential use as a jet lag disorder treatment, Vanda Pharmaceuticals is pursuing a new route to establish the drug in the space. Hetlioz was approved more than a decade ago for non-24-hour sleep …

Source: Fierce Pharma - Neutral
Published on Apr 11, 2025

Argenx stays on a roll with Vyvgart, gaining FDA nod for at-home prefilled syringe

Already thriving with a successful launch of infused Vyvgart and its subcutaneous follow-on Vyvgart Hytrulo to the tune of $2.2 billion in sales last year, argenx has scored FDA approval for a new formulation of the treatment, which gives patients the …

Source: Fierce Pharma - Neutral
Published on Apr 11, 2025

'Shocked' FDA staffers walked out on RFK Jr.'s slur-ridden speech: report

Visiting the FDA on Friday, HHS Secretary Robert F. Kennedy Jr. had several “off -the-cuff” remarks which stunned many staffers present, according to a POLITICO report. The outlet obtained a transcript and audio of the speech where Kennedy claimed, “The …

Source: Raw Story - Left-wing
Published on Apr 11, 2025

FDA Approves Nivolumab/Ipilimumab for Metastatic or Unresectable HCC

The FDA announced its approval of frontline nivolumab (Opdivo) plus ipilimumab (Yervoy) for use in adult patients with unresectable or metastatic hepatocellular carcinoma (HCC), according to an announcement from the agency.1 The approval is based on data …

Source: Oncology Nursing News - Label Pending
Published on Apr 11, 2025

Honey-roasted peanuts recalled after customer’s allergic reaction: FDA

An Ohio-based nut company is recalling over 140 cases of honey-roasted peanuts due to the possible presence of an allergen. According to a Food & Drug Administration (FDA) notice, the Trophy Nut Company is recalling 143 cases of its Heinen’s brand 8.25 …

Source: New York Post - Right-wing
Published on Apr 11, 2025

FDA Approves Bevacizumab Biosimilar for Various Cancer Types

The FDA has approved bevacizumab-nwgd (Jobevne; Biocon Biologics), a biosimilar referencing bevacizumab (Avastin; Genentech) for the treatment of several different types of cancers. This approval marks bevacizumab-nwgd as the sixth reference product to …

Source: Pharmacy Times - Neutral
Published on Apr 11, 2025

FDA to Phase Out Animal Testing

The US Food and Drug Administration (FDA) has announced its intention to phase out mandatory animal testing for monoclonal antibodies and other drugs with the aim of modernizing preclinical translational science, enhancing drug safety, reducing development …

Source: The Medicine Maker - Neutral

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Published on April 11, 2025 - 21:35 GMT

FDA Honored to Welcome HHS Secretary Robert F. Kennedy, Jr. to FDA Campus

For Immediate Release: April 11, 2025 The U.S. Food and Drug Administration today welcomed HHS Secretary Robert F. Kennedy, Jr. to its headquarters in Silver Spring, Maryland, a visit that included remarks to FDA employees, meetings with agency leadership, …

Distribution channels: Food & Beverage Industry
Published on April 11, 2025 - 21:10 GMT

FDA Honored to Welcome HHS Secretary Robert F. Kennedy, Jr. to FDA Campus

For Immediate Release: April 11, 2025 The U.S. Food and Drug Administration today welcomed HHS Secretary Robert F. Kennedy, Jr. to its headquarters in Silver Spring, Maryland, a visit that included remarks to FDA employees, meetings with agency leadership, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 11, 2025 - 17:26 GMT

Aldeyra Therapeutics, Inc. (ALDX) Faces Scrutiny After Stock Drops 70% On FDA’s Reproxalap Complete Response Letter – ...

SAN FRANCISCO, April 11, 2025 (GLOBE NEWSWIRE) -- On April 3, 2025 investors in Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) saw the price of their shares crash over 70% after the company announced that it received a Complete Response Letter (“CRL”) from the …

Distribution channels: Consumer Goods, Law ...
Published on April 12, 2025 - 06:57 GMT

PrimeBiome— How PrimeBiome Gummies Boost Glowing Skin With Bacillus Coagulans & Babchi

ST. PETERSBURG, Fla., April 12, 2025 (GLOBE NEWSWIRE) -- In today's highly competitive landscape of health and wellness supplements, consumers are increasingly drawn to products backed by solid science and real-world results. PrimeBiome, a natural …

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Published on April 12, 2025 - 06:40 GMT

Lipozem Reviews (BUYER ALERT!) Is It Legit And Safe To Use? Consumer Report On Reddit Breaks It Down!

MIAMI, April 12, 2025 (GLOBE NEWSWIRE) -- The Lipozem weight loss supplement has been garnering attention in the weight loss supplement market for quite some time. People are wondering what this hype is about, and this Lipozem review is going to reveal the …

Distribution channels: Healthcare & Pharmaceuticals Industry, Media, Advertising & PR ...
Published on April 12, 2025 - 06:37 GMT

Aqua Sculpt Reviews (We Tested It) Here’s Our Honest AquaSculpt Ice Water Hack Review After 96 Days!

MINNEAPOLIS, April 12, 2025 (GLOBE NEWSWIRE) -- Aqua Sculpt is designed to support weight loss by leveraging the ice water hack. It stimulates the metabolism, increases energy expenditure, and causes your body to burn extra calories in the process. The …

Distribution channels: Consumer Goods, Media, Advertising & PR ...
Published on April 11, 2025 - 14:38 GMT

FDA approves nivolumab with ipilimumab for unresectable or metastatic hepatocellular carcinoma

On April 11, 2025, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb Company) for the first-line treatment of adult patients with unresectable or metastatic …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on April 10, 2025 - 22:45 GMT

FDA Commissioner and Congress Speaking Same Language to Reduce Animal Testing in Drug Development

HHS Secretary Kennedy, FDA Commissioner Makary signal move away from animal testing, while a group of lawmakers introduces the FDA Modernization Act 3.0 WASHINGTON, DC, UNITED STATES, April 10, 2025 /⁨EINPresswire.com⁩/ -- Today, Animal Wellness …

Distribution channels: Business & Economy, Healthcare & Pharmaceuticals Industry ...

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Published on April 11, 2025 - 20:24 GMT

TheraCann International and Sprout AI Near Completion of Amalgamation Process on the Canadian Securities Exchange

TheraCann International Benchmark Corp (CSE:BYFM) VANCOUVER, BRITISH COLUMBIA, CANADA, April 11, 2025 /⁨EINPresswire.com⁩/ -- TheraCann International Benchmark Corp (TIBC) and its subsidiary Sprout AI Inc. (SAI – CSE: BYFM) are delighted to …

Distribution channels: Agriculture, Farming & Forestry Industry, Banking, Finance & Investment Industry ...
Published on April 11, 2025 - 19:47 GMT

Lazer Logistics Rises to No. 75 on Transport Topics’ Top 100 Logistics Companies List

Lazer Logistics again earned a spot on Transport Topics’ Top 100 Logistics Companies in North America, moving up two positions to No. 75. ALPHARETTA, GA, UNITED STATES, April 11, 2025 /⁨EINPresswire.com⁩/ -- April 11, 2025 – Lazer Logistics has …

Distribution channels: Consumer Goods, Food & Beverage Industry ...
Published on April 11, 2025 - 19:19 GMT

Surplus Network Expands Services to Support Manufacturers in Unlocking Value from Surplus Assets

Surplus Network Expands Services to Support Manufacturers in Unlocking Value from Surplus Assets SACRAMENTO, CA, UNITED STATES, April 11, 2025 /⁨EINPresswire.com⁩/ -- Surplus Network, a leading B2B platform for surplus asset liquidation, is …

Distribution channels: Agriculture, Farming & Forestry Industry, Automotive Industry ...
Published on April 11, 2025 - 18:34 GMT

No Label Brewing Co. Honored at VFW Post 9182 Awards Night at Cinco Ranch Golf Club for Service to the Katy Community

Recognized at VFW Post 9182’s Annual Awards Night, No Label Brewing was honored for its ongoing support of veterans, students, and the Katy community. KATY, TX, UNITED STATES, April 11, 2025 /⁨EINPresswire.com⁩/ -- No Label Brewing Co. Honored at …

Distribution channels: Culture, Society & Lifestyle, Education ...
Published on April 11, 2025 - 17:56 GMT

LSG SKY CHEFS - AMERICAS WINS AIRLINE CATERER OF THE YEAR FOR NORTH AMERICA AT 2025 PAX INTERNATIONAL READERSHIP AWARDS

Airline Catering Company Wins for Third Consecutive Year IRVING, TX, UNITED STATES, April 11, 2025 /⁨EINPresswire.com⁩/ -- LSG Sky Chefs – Americas (Sky Chefs), the market leader in airline catering and culinary solutions, today announced it was …

Distribution channels: Aviation & Aerospace Industry, Food & Beverage Industry ...
Published on April 11, 2025 - 17:50 GMT

Santa Barbara Culinary Experience Grand Wine Tasting

The Santa Barbara Culinary Experience- Grand Wine Tasting is back, May 17th. SANTA BARBARA, CA, UNITED STATES, April 11, 2025 /⁨EINPresswire.com⁩/ -- Santa Barbara Culinary Experience Returns May 12-18- Tickets now on sale for weeklong celebration …

Distribution channels: Conferences & Trade Fairs, Culture, Society & Lifestyle ...
Published on April 11, 2025 - 15:44 GMT

The Hidden Side of Sustainability: Filta Kleen's COO Ron Weber Explains Ventilation Compliance in NYC’s Food Industry

In New York City’s dense urban landscape, commercial kitchens face mounting pressure to curb smoke and odors. BROOKLYN, NY, UNITED STATES, April 11, 2025 /⁨EINPresswire.com⁩/ -- In New York City’s dense urban landscape, commercial kitchens face …

Distribution channels: Building & Construction Industry, Business & Economy ...
Published on April 11, 2025 - 13:05 GMT

Chocolate Caramel Market Is Booming So Rapidly | Ghirardelli, Cadbury, Storck

The Global Chocolate Caramel Market is projected to grow from $6.4 Billion in 2025 to $13.3 Billion by 2034, at a CAGR of 9.6%. HYDERABAD, TELANGANA, INDIA, April 11, 2025 /⁨EINPresswire.com⁩/ -- USD Analytics recently introduced Global Chocolate …

Distribution channels: Food & Beverage Industry ...
Published on April 11, 2025 - 13:00 GMT

Restaurant Tech Trends 2025: Self-Service Kiosks & KDS Systems Take Over Halal Dining

Tiponline POS brings modern self-ordering kiosks and digital kitchen displays to Halal restaurants — all features included, no monthly fees. ONTARIO, CANADA, April 11, 2025 /⁨EINPresswire.com⁩/ -- The restaurant industry is evolving fast, and 2025 …

Distribution channels: Business & Economy, Companies ...
Published on April 11, 2025 - 12:15 GMT

Fruit Infused Water Market Forecasted to Reach USD 20.09 Billion by 2034, Driven by Health-Conscious Consumer Trends

Fruit Infused Water Market Research Report By Product Type, By Distribution Channel, By Packaging, By Flavor , By End-Use and By Regional - Forecast to 2034 NEW YORK, NY, UNITED STATES, April 11, 2025 /⁨EINPresswire.com⁩/ -- The global Fruit …

Distribution channels: Food & Beverage Industry ...
Published on April 11, 2025 - 12:01 GMT

Canada Energy Drinks Market Poised for Robust Growth: Forecast to Reach USD 12.33 Billion by 2035 | Red Bull, Coco Hydro

Canada Energy Drinks Market Research Report: By Product Type Outlook, Packaging Type Outlook, Type Outlook and Distribution Channel Outlook - Forecast to 2035 CANADA, CA, UNITED STATES, April 11, 2025 /⁨EINPresswire.com⁩/ -- The Canada Energy …

Distribution channels: Food & Beverage Industry ...
Published on April 12, 2025 - 00:00 GMT

Duda Farm Fresh Foods, Inc. Emite Aviso Para 1.587 Cajas de Marketside 4in/1.6 oz Bundle Pack por Posible Riesgo Para la ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Food & Beverage Industry
Published on April 11, 2025 - 23:55 GMT

Duda Farm Fresh Foods, Inc. Emite Aviso Para 1.587 Cajas de Marketside 4in/1.6 oz Bundle Pack por Posible Riesgo Para la ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Food & Beverage Industry
Published on April 11, 2025 - 23:51 GMT

Duda Farm Fresh Foods, Inc. Emite Aviso Para 1.587 Cajas de Marketside 4in/1.6 oz Bundle Pack por Posible Riesgo Para la ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Food & Beverage Industry
Published on April 11, 2025 - 11:48 GMT

Fructo Oligosaccharides Market Poised to Reach USD 8.24 Billion by 2032, Driven by Health-Conscious Consumer Trends

Fructo Oligosaccharides Market Research Report By Application, By Function, By Source, By Form By Regional - Forecast to 2032 NEW YORK, NY, UNITED STATES, April 11, 2025 /⁨EINPresswire.com⁩/ -- The global Fructo Oligosaccharides (FOS) market is …

Distribution channels: Food & Beverage Industry ...
Published on April 11, 2025 - 11:41 GMT

Italy's Extra Virgin Olive Oil Market Poised for Growth: Projected to Reach USD 910 Million by 2035| Bertolli, Monini

Italy Extra Virgin Olive Oil Market Research Report: By Packaging Outlook, By Distribution Channel Outlook and By Category Outlook - Forecast to 2035 ITALY, ITALY, ITALY, April 11, 2025 /⁨EINPresswire.com⁩/ -- The Italy Extra Virgin Olive Oil ( …

Distribution channels: Food & Beverage Industry ...
Published on April 11, 2025 - 10:00 GMT

International Pizza Chain Continues Slicing Through Growth Plans to Achieve Milestone 800th Restaurant Opening

Sbarro celebrates multiple worldwide openings this week as growth continues for the Original XL NY Pizza Brand COLUMBUS, OH, UNITED STATES, April 11, 2025 /⁨EINPresswire.com⁩/ -- This week marks a significant milestone for the international QSR …

Distribution channels: Business & Economy, Companies ...
Published on April 11, 2025 - 21:35 GMT

FDA Honored to Welcome HHS Secretary Robert F. Kennedy, Jr. to FDA Campus

For Immediate Release: April 11, 2025 The U.S. Food and Drug Administration today welcomed HHS Secretary Robert F. Kennedy, Jr. to its headquarters in Silver Spring, Maryland, a visit that included remarks to FDA employees, meetings with agency leadership, …

Distribution channels: Food & Beverage Industry
Published on April 11, 2025 - 20:30 GMT

Beyond Oil Expands into Three European Territories as Part of New Distribution Agreement With Royalty Trade and Receives ...

VANCOUVER, BC and KIBBUTZ YIFAT, Israel, April 11, 2025 (GLOBE NEWSWIRE) -- Beyond Oil Ltd. (CSE: BOIL) (OTCQB: BEOLF) (Frankfurt: UH9) ("Beyond Oil" or the "Company"), a food-tech innovation company dedicated to reducing health risks …

Distribution channels: Banking, Finance & Investment Industry, Business & Economy ...
Published on April 11, 2025 - 20:10 GMT

Coca-Cola Consolidated, Inc. Announces Second Quarter Dividend

CHARLOTTE, N.C., April 11, 2025 (GLOBE NEWSWIRE) -- Coca-Cola Consolidated, Inc. (NASDAQ: COKE) announced that its Board of Directors has declared a dividend for the second quarter of 2025 of $2.50 per share on shares of the Company's Common Stock and …

Distribution channels: Banking, Finance & Investment Industry, Food & Beverage Industry ...