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Published on Sep 29, 2022

Treatment for adults with chronic skin condition approved by FDA

The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adult patients with prurigo nodularis. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, …

Source: Labiotech - Neutral
Published on Sep 29, 2022

Berkshire Sterile client receives FDA approval on product indicated to reduce risk of hearing loss for childhood cancer ...

Lee, MA, Sept. 29, 2022 (GLOBE NEWSWIRE) -- On September 21st, 2022, Berkshire Sterile Manufacturing’s (BSM) client, Fennec Pharmaceuticals Inc., received FDA approval of their drug product, PEDMARK – a sodium thiosulfate Injection with an indication to …

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Published on Sep 29, 2022

Axsome Therapeutics Announces Plans to Resubmit AXS-07 NDA Based on Successful FDA Type A Meeting

NEW YORK, Sept. 29, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, announced that, following a Type A …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on Sep 29, 2022

InflaRx Submits Request for Emergency Use Authorization to US FDA for Vilobelimab for Treatment of Critically Ill COVID-...

Company also earns FDA Fast Track designation for vilobelimab to treat critically ill COVID-19 patients EUA submission based on Phase III results in critically ill COVID-19 patients, recently published in The Lancet Respiratory Medicine Request for EUA …

Distribution channels: Healthcare & Pharmaceuticals Industry, Media, Advertising & PR ...
Published on Sep 30, 2022

Price of Cambridge biotech’s new ALS drug criticized by watchdog group

The day after federal regulators approved its hotly debated new ALS drug, a Cambridge biotech on Friday set the annual list price at about $158,000 for the first year, drawing swift criticism from a nonprofit watchdog group. Top executives at Amylyx …

Source: The Boston Globe - Massachusetts - Neutral
Published on Sep 30, 2022

Congress Clears Stopgap Spending Bill With $12.3 Billion in Ukraine Aid

WASHINGTON — Congress gave final approval on Friday to a short-term spending package that would keep the government open through mid-December, staving off a midnight shutdown and sending about $12.3 billion in military and economic aid to Ukraine. The …

Source: The New York Times - Neutral
Published on Sep 29, 2022

C4 Therapeutics Receives Study May Proceed Letter from U.S. FDA to Initiate Phase 1/2 Clinical Trial of CFT1946, an ...

WATERTOWN, Mass., Sept. 29, 2022 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines …

Distribution channels: Healthcare & Pharmaceuticals Industry, Technology ...
Published on Sep 29, 2022

FDA Proposes Updated Definition of ‘Healthy’ Claim on Food Packages

The Food and Drug Administration Wednesday proposed updated criteria for labeling foods with the nutrient content claim “healthy” on their packaging. The proposal comes the same day as the White House Conference on Hunger, Nutrition, and Health. The rule …

Source: KFGO - North Dakota - Neutral
Published on Sep 29, 2022

metaMe Health partners with Launchit Ventures to market Regulora, an FDA-cleared Prescription Digital Therapeutic for ...

HAMILTON, Ontario and CHICAGO, Sept. 29, 2022 (GLOBE NEWSWIRE) -- Launchit Ventures, Inc., a HealthTech solutions provider and global commercialization partner developing new technology-led business solutions faster and with less risk, and metaMe Health, …

Distribution channels: Companies, Healthcare & Pharmaceuticals Industry ...
Published on Sep 30, 2022

Amylyx prices newly approved ALS drug at $158,000 per year

Test tubes are seen in front of Amylyx logo in this illustration, July 24, 2022. REUTERS/Dado Ruvic/Illustration/File Photo Sept 30 (Reuters) - Amylyx Pharmaceuticals Inc (AMLX.O) said on Friday it has set the list price of its newly approved …

Source: Reuters - Neutral
Published on Sep 30, 2022

Marlboro maker Altria opts to end non-compete deal with Juul

Sept 30 (Reuters) - Marlboro maker Altria Group Inc (MO.N) said it had exercised the option to be released from its non-compete deal with Juul Labs Inc, nearly four years after buying a 35% stake in the e-cigarette maker that was then at the zenith of its …

Source: Reuters - Neutral
Published on Sep 30, 2022

Intercept's NASH drug fails late-stage trial, shares tumble

Sept 30 (Reuters) - Intercept Pharmaceuticals Inc (ICPT.O) said on Friday its treatment for patients with advanced liver scarring due to non-alcoholic steatohepatitis (NASH) failed to meet the main goal of a late-stage study, sending its shares down as …

Source: Reuters - Neutral
Published on Sep 29, 2022

Dupixent® (dupilumab) Approved by FDA as the First and Only Treatment Indicated for Prurigo Nodularis

Dupixent significantly reduced itch and skin lesions compared to placebo in direct-to-Phase 3 program consisting of two pivotal trials About 75,000 adults in the U.S. living with prurigo nodularis are most in need of new treatment options Approval …

Source: BioSpace - Neutral
Published on Sep 29, 2022

Revive Therapeutics To Schedule DSMB Meeting In Lieu Of FDA Decision

Revive Therapeutics Ltd. (CNSX: RVV) (OTCMKTS: RVVTF) obtained a material ruling from the U.S. Food & Drug Administration (FDA) pertaining to its current Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine to treat COVID-19. While …

Source: The Dales Report - Neutral
Published on Sep 29, 2022

US FDA issues warning letter to Lupin's Tarapur unit

The United States Food and Drug Administration (US FDA) has issued a warning letter to Lupin's Tarapur, Maharashtra facility, the company said in a stock exchange filing on Thursday. The federal agency had inspected Lupin's Tarapur site from March …

Source: The Economic Times - Neutral
Published on Sep 29, 2022

Lupin gets warning letter from FDA for Tarapur facility, stock falls over 2%

Shares of Indian multinational pharmaceutical company fell over 2 in Thursday’s trade after the company received a warning letter from the US FDA for its facility at . “We wish to inform you that the company has received a warning letter from the US FDA …

Source: Economic Times - Uncategorized
Published on Sep 29, 2022

Lupin dips 3% as US FDA issues warning letter for Tarapur facility

Shares of Lupin dipped 3 per cent to Rs 652 on the BSE in Thursday's intra-day trade after the company received warning letter for its Tarapur, Maharashtra facility. During the past four trading days, the stock gained 3.4 per cent in an otherwise weak …

Source: Business Standard - Neutral
Published on Sep 29, 2022

If it's marked healthy, is it really healthy? White House works to disclose deceptive food labels

WASHINGTON (KABC) -- Grocery store aisles are filled with products that say "healthy" on the package, but labels on the outside don't always tell the truth about what's on the inside. "It can be very, very deceiving, of course," …

Source: ABC7 - California - Neutral
Published on Sep 29, 2022

New outbreak under investigation; FDA ends work on another without finding source

The FDA is investigating one new outbreak and has closed an investigation on another. On Wednesday the Food and Drug Administration announced a new Salmonella Litchfield outbreak that has sickened at least 28 patients. The source of the pathogen has not …

Source: Food Safety News - Neutral

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Published on October 1, 2022 - 01:48 GMT

FDA Roundup: September 30, 2022 

For Immediate Release: September 30, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the FDA Voices: “FDA Continues Important Work on Substance Use and Overdose …

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Published on October 1, 2022 - 01:48 GMT

FDA Pathway Supports Long-Term Stability, Diversity of Safe and Nutritious Infant Formula Supply in the U.S.

For Immediate Release: September 30, 2022 Today, the U.S. Food and Drug Administration published guidance that will help provide a pathway for infant formulas operating under enforcement discretion in the U.S. to remain on the market. This will help ensure …

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Published on October 1, 2022 - 02:51 GMT

FDA Continues Important Work on Substance Use and Overdose Prevention Efforts

Image By: Robert M. Califf, M.D., Commissioner of Food and Drugs Overdose prevention, reduction in opioid and other substance use disorders (SUD), and effective treatment and support for those with SUD are key priorities for the U.S. Food and Drug …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on October 1, 2022 - 01:13 GMT

FDA Roundup: September 30, 2022 

For Immediate Release: September 30, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the FDA Voices: “FDA Continues Important Work on Substance Use and Overdose …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 30, 2022 - 17:43 GMT

Crapo and Paul Shepherd Bipartisan FDA Modernization Act through Senate to Cut Drug Costs, End Animal Testing Mandates

Groundbreaking Legislation has the Potential to Spare Animals, Bring Safer and Better Treatments to Patients, and Drive Down Drug Prices WASHINGTON, D.C., UNITED STATES, September 30, 2022 /⁨EINPresswire.com⁩/ -- On Thursday, the U.S. Senate …

Distribution channels: Healthcare & Pharmaceuticals Industry, Law ...
Published on October 1, 2022 - 01:13 GMT

FDA Approves New Treatment Option for Patients with ALS

For Immediate Release: September 29, 2022 The U.S. Food and Drug Administration today approved Relyvrio (sodium phenylbutyrate/taurursodiol) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease. “ …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on October 1, 2022 - 02:51 GMT

FDA Approves New Treatment Option for Patients with ALS

For Immediate Release: September 29, 2022 The U.S. Food and Drug Administration today approved Relyvrio (sodium phenylbutyrate/taurursodiol) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease. “ …

Distribution channels: Food & Beverage Industry
Published on October 1, 2022 - 01:13 GMT

FDA Pathway Supports Long-Term Stability, Diversity of Safe and Nutritious Infant Formula Supply in the U.S.

For Immediate Release: September 30, 2022 Today, the U.S. Food and Drug Administration published guidance that will help provide a pathway for infant formulas operating under enforcement discretion in the U.S. to remain on the market. This will help ensure …

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Published on September 30, 2022 - 22:12 GMT

$5.6 Million Verdict for Gainesville Man For Spinal Cord Injury Incurred at Pool Party

Defendants who hosted a BYOB event were found liable for damages an underage minor suffered in a pool accident after being permitted to drink alcohol. PENSACOLA, FL, UNITED STATES, September 30, 2022 /⁨EINPresswire.com⁩/ -- A jury awarded $5.6MM …

Distribution channels: Business & Economy, Food & Beverage Industry ...
Published on September 30, 2022 - 20:19 GMT

Steelite International Announces Acquisition of Walco Stainless

Steelite International becomes the largest supplier of flatware in the America’s with Walco Stainless acquisition NEW CASTLE, PENNSYLVANIA, UNITED STATES, September 30, 2022 /⁨EINPresswire.com⁩/ -- Steelite International ("Steelite" or …

Distribution channels: Amusement, Gaming & Casino, Business & Economy ...
Published on September 30, 2022 - 19:58 GMT

Set Up LLC For Cryptocurrency in American Samoa, USA

Set Up LLC For Cryptocurrency in American Samoa for Protection. There are many legal issues you should be aware of before trading cryptocurrencies in the USA. SILVERADO, CA, UNITED STATES, September 30, 2022 /⁨EINPresswire.com⁩/ -- Set Up LLC For …

Distribution channels: Banking, Finance & Investment Industry, Food & Beverage Industry ...
Published on September 30, 2022 - 19:15 GMT

Compound Isomaltitol Market worth $923.4 Million by 2027 at a growth rate of 6.0% - IndustryARC

Surging Applications of Isomaltitol are Projected to Drive the Growth of Global Compound Isomaltitol Market HYDERABAD, TELANGANA, INDIA, September 30, 2022 /⁨EINPresswire.com⁩/ -- IndustryARC, in its latest report, predicts that The Compound …

Distribution channels: Food & Beverage Industry, Healthcare & Pharmaceuticals Industry ...
Published on September 30, 2022 - 19:00 GMT

At 10.8 % CAGR, Weight Loss Diet Market Size Worth USD 294.4 Billion by 2027: IndustryARC

The Growing Prevalence of Obesity and the General Obese Population Across the Age Groups have been a Primal Weight Loss Diet Market Driver HYDERABAD, TELANGANA, INDIA, September 30, 2022 /⁨EINPresswire.com⁩/ -- IndustryARC, in its latest report, …

Distribution channels: Food & Beverage Industry, Healthcare & Pharmaceuticals Industry ...
Published on September 30, 2022 - 18:01 GMT

Customerization is now a Canada Digital Adoption Program Digital Advisor

Toronto, CA – 30 September 2022 Canadian businesses can now take advantage of the Canada Digital Adoption Program (CDAP) with the help of a new Digital Advisor. CONCORD, ONTARIO, CANADA, September 30, 2022 /⁨EINPresswire.com⁩/ -- Customerization, …

Distribution channels: Automotive Industry, Aviation & Aerospace Industry ...
Published on September 30, 2022 - 17:45 GMT

At 3.7 % CAGR, Castor Market Size Worth USD 2.9 Billion by 2027: IndustryARC

Surging Applications of Castor Oil are Projected to Drive the Growth of the Castor Market. HYDERABAD, TELANGANA, INDIA, September 30, 2022 /⁨EINPresswire.com⁩/ -- IndustryARC, in its latest report, predicts that Castor Market size is estimated to …

Distribution channels: Beauty & Hair Care, Food & Beverage Industry ...
Published on September 30, 2022 - 15:40 GMT

FAQs on SOPs: Released by Retail Consultants YRC

YRC is a retail and eCommerce consulting enterprise with a scaling presence in the Middle East. DUBAI, DUBAI, DUBAI, September 30, 2022 /⁨EINPresswire.com⁩/ -- In its ten years of experience, the team has developed SOPs (Standard Operating …

Distribution channels: Consumer Goods, Food & Beverage Industry ...
Published on September 30, 2022 - 15:15 GMT

Monosodium Glutamate Market size was valued at $5,638 million - IndustryARC

Monosodium Glutamate market size was valued at $5,638 million in 2020, and is anticipated to grow at a CAGR of 5.81% during the forecast period 2021-2026. HYDERABAD, TELANGANA, INDIA, September 30, 2022 /⁨EINPresswire.com⁩/ -- Monosodium Glutamate …

Distribution channels: Beauty & Hair Care, Food & Beverage Industry ...
Published on September 30, 2022 - 15:00 GMT

Molasses Market size is forecast to reach $13.8 billion - IndustryARC

Molasses market size is forecast to reach $13.8 billion by 2026, growing at a CAGR of 4.0% during the forecast period 2021-2026. HYDERABAD, TELANGANA, INDIA, September 30, 2022 /⁨EINPresswire.com⁩/ -- Molasses market size is forecast to reach $13. …

Distribution channels: Consumer Goods, Food & Beverage Industry ...
Published on October 1, 2022 - 02:51 GMT

FDA Approves New Treatment Option for Patients with ALS

For Immediate Release: September 29, 2022 The U.S. Food and Drug Administration today approved Relyvrio (sodium phenylbutyrate/taurursodiol) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease. “ …

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Published on October 1, 2022 - 02:51 GMT

Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Atenolol 25 mg Tablets and Clopidogrel 75 mg ...

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 …

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Published on October 1, 2022 - 02:48 GMT

Whole Foods Market Issues Allergy Alert for Zerto Fontal Cheese Sold in Connecticut, New Jersey, and New York

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 …

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Published on October 1, 2022 - 02:48 GMT

Old Europe Cheese, Inc. Issues Voluntary Recall of Its Brie and Camembert Cheeses Due to Possible Health Risk

Brand Product Name UPC Code BLACK BEAR 6 lb Black Bear Wheel N/A BLOCK AND BARREL 2.2 lb Block and Barrel Brie 078982603281 BLOCK AND BARREL 6.6 lb Block and Barrel Brie N/A CHARMANT 2.2 lb Brie - double crème, whole wheel - CHARMANT N/A …

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Published on October 1, 2022 - 02:41 GMT

Old Europe Cheese, Inc. Issues Voluntary Recall of Its Brie and Camembert Cheeses Due to Possible Health Risk

Brand Product Name UPC Code BLACK BEAR 6 lb Black Bear Wheel N/A BLOCK AND BARREL 2.2 lb Block and Barrel Brie 078982603281 BLOCK AND BARREL 6.6 lb Block and Barrel Brie N/A CHARMANT 2.2 lb Brie - double crème, whole wheel - CHARMANT N/A …

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Published on October 1, 2022 - 02:41 GMT

Whole Foods Market Issues Allergy Alert for Zerto Fontal Cheese Sold in Connecticut, New Jersey, and New York

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 …

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Published on September 30, 2022 - 14:33 GMT

Seaweed Market to Grow at 12.0% CAGR through 2018 to 2024 - Irish Seaweeds, Mara Seaweed

Seaweed Market by Product and Application - Global Opportunity Analysis and Industry Forecast, 2018-2024 PORTLAND, OR, UNITED STATES, September 30, 2022 /⁨EINPresswire.com⁩/ -- Increase awareness towards health benefits of seaweeds and changes in …

Distribution channels: Business & Economy, Food & Beverage Industry ...
Published on September 30, 2022 - 14:30 GMT

Global Mineral Ingredients Market size is forecast to reach $1.3 billion - IndustryARC

Global mineral ingredients market size is forecast to reach $1.3 billion by 2026, growing at a CAGR of 6.1% during the forecast period 2021-2026 HYDERABAD, TELANGANA, INDIA, September 30, 2022 /⁨EINPresswire.com⁩/ -- Global mineral ingredients …

Distribution channels: Food & Beverage Industry, World & Regional ...
Published on September 30, 2022 - 14:13 GMT

Calcium Tartrate Market Trend, Analysis, Industry Overview, Latest Insights and Business Opportunities 2022-2029

Growth in the food and beverages industry where calcium tartrate is used as a preservative propels growth of the calcium tartrate market. OREGON, PORTLAND, UNITED STATES, September 30, 2022 /⁨EINPresswire.com⁩/ -- Growth in the food and beverages …

Distribution channels: Chemical Industry, Food & Beverage Industry ...
Published on September 30, 2022 - 14:00 GMT

MUD\WTR Captures the Mushroom Movement in New Short Film Featuring Mycologist William-Padilla Brown

A new release from MUD\FILMS—MUD\WTR's in-house production studio—follows a citizen scientist on an expedition to discover meaningful contributions to mycology. SANTA MONICA, CALIFORNIA, UNITED STATES, September 30, 2022 /⁨EINPresswire.com⁩/ …

Distribution channels: Culture, Society & Lifestyle, Environment ...