FDA News Monitoring Service

Statement from Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on impurities found in ...

For Immediate Release: December 05, 2019 Statement From: Statement Author Leadership Role Director - Center for Drug Evaluation and Research Janet Woodcock M.D. The U.S. Food and Drug Administration has been investigating the presence of genotoxic …

FDA probes diabetes drug metformin for carcinogen NDMA

(Reuters) - The U.S. Food and Drug Administration is investigating whether the diabetes drug metformin had unsafe levels of a cancer-causing chemical and will recommend recalls as appropriate, the agency said on Thursday. The move is part of the agency’s …

Bristol─Myers Squibb's ORENCIA receives US FDA breakthrough therapy designation

Bristol-Myers Squibb Company announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ORENCIA (abatacept) for the prevention of moderate to severe acute graft-versus-host disease (GvHD) in hematopoietic stem …

FDA: Listeria Yet Again, Here Is A Sushi, Salad, And Spring Roll Recall

7–Eleven is launching a new fresh food program that delivers grocery staples to its convenience ... [+] stores daily, providing a lucrative new market for food manufacturers. Fresh Okami sushi is just one of the fresh products. Cardinal Distribution in …

The J. M. Smucker Company Issues Voluntary Recall of Specific Lots of Special Kitty® Wet, Canned Cat Food Due to Health ...

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 Summary Company …

FDA Clears Faster Diagnostic Test for MRSA

The US Food and Drug Administration (FDA) has approved a new, faster diagnostic test based on bacterial viability and a novel technology to detect methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization, a common cause of hospital- …

FDA investigates diabetes drug metformin for NDMA carcinogen

Dec 5 (Reuters) - The U.S. Food and Drug Administration said on Thursday it was investigating whether metformin diabetes medicines sold in the United States contain unsafe levels of a carcinogen called NDMA. Metformin is the first-line medication for the …

FDA Launches Infectious Disease Crowdsourcing App for Clinicians

The US Food and Drug Administration (FDA) has globally launched CURE ID, an internet-based repository that allows healthcare providers to share and discuss their experiences treating difficult-to-treat infectious diseases through a website, a smartphone, …

US FDA approves generic versions of Novartis blockbuster MS treatment

World The U.S. Food and Drug Administration on Thursday approved three generic versions of Swiss drugmaker Novartis AG's top-selling multiple sclerosis (MS) medicine Gilenya. 06 Dec 2019 05:26AM Bookmark REUTERS: The U.S. Food and Drug Administration …

U.S. FDA approves generic versions of Novartis blockbuster MS treatment

FILE PHOTO: The logo of Swiss drugmaker Novartis AG is seen at its headquarters in Basel, Switzerland January 25, 2017. REUTERS/Arnd Wiegmann (Reuters) - The U.S. Food and Drug Administration on Thursday approved three generic versions of Swiss …

Alector Announces FDA Fast Track Designation Granted to AL001 for the Treatment of Patients with Frontotemporal Dementia

SOUTH SAN FRANCISCO, Calif., Dec. 05, 2019 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a clinical stage biotechnology company pioneering immuno-neurology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track …

FDA Approves First Generics Of Gilenya

Israeli start-up to process blood test in 10 minutes cleared by US FDA

FDA approves first generics of Gilenya

For Immediate Release: December 05, 2019 The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients. “Approving …

GSK-owned ViiV Healthcare seeks FDA approval for new HIV drug

RESEARCH TRIANGLE PARK – ViiV Healthcare, which has a large research and development operation in RTP, has filed for approval of an AIDS treatment that would help people infected with HIV who have developed a resistance or intolerance to other medications. …

It’s Common Knowledge That Many Side Effects Don’t Get Reported To FDA. But Study Reveals Startling Scope Of Problem.

The study found that in one drug only 1% of an estimated 276,000 serious adverse events had been reported. Researchers say they data emphasizes the need for better surveillance of the risk of injury. In other pharmaceutical news: biotechs react to the …

FDA, NIH's newest app asks clinicians to log case data when treating difficult infections

The FDA and National Institutes of Health are tapping the clinical community and a newly launched mobile platform in its search for novel infectious disease interventions. Called CURE ID, the online data repository will allow clinicians to report instances …

Political Cornflakes: New regs will knock hundreds of thousands of low-income Americans from food stamp program

Rules expected to be announced Wednesday would bump an estimated 750,000 people from the food stamp program. The new regulations would make it harder for states to waive a requirement that beneficiaries work or enroll in vocational training, sources said. …

FDA Rejects Enzyvant’s Regenerative Therapy for Rare Immune Disorder

Xconomy Boston —  [Corrected 12:27 p.m. See below.] The FDA has rejected an experimental regenerative therapy that Enzyvant developed to restore immune system function in babies born with a rare disorder. The agency cited manufacturing issues, according to …

Plastic Free World Conference & Expo

A World FREE From Plastic Waste COLOGNE, ., GERMANY, December 6, 2019 /⁨EINPresswire.com⁩/ -- Industry Solutions for a world FREE From Plastic Waste New Materials Innovations, Technologies & Circular Economy Solutions To End Waste Plastic …

Emblica Officinalis 2019 Global Opportunities And Industry Analysis Forecasts To 2024

Global Emblica Officinalis Market Status, By Players, Types, Applications And Forecast To 2025 PUNE, MAHARASHTRA, INDIA, December 6, 2019 /⁨EINPresswire.com⁩/ -- Emblica Officinalis Industry Description Emblica officinalis is also known as …

Frozen Potato Fries Market 2019, Global Industry Analysis, Size, Share, Growth, Trends and Forecast - 2024

A New Market Study, titled “Frozen Potato Fries Market Upcoming Trends, Growth Drivers and Challenges” has been featured on WiseGuyReports. PUNE, MAHARASTRA, INDIA, December 6, 2019 /⁨EINPresswire.com⁩/ -- Summary A New Market Study, titled “ …

Champagne Cooler Market – Global Industry Analysis, Size, Share, Growth, Trends & Forecast 2019 – 2025

Latest Research: 2019 Global Champagne Cooler Market Report PUNE , MAHARASHTRA, INDIA, December 6, 2019 /⁨EINPresswire.com⁩/ -- Global Champagne Cooler Industry General Overview Our professional market survey report of the Global Champagne …

Crescent Acquires Kimpton Brice Hotel in Savannah

Crescent enters Savannah market with The Kimpton Brice hotel purchase located in the Historic District of Savannah FORT WORTH, TEXAS, US, December 5, 2019 /⁨EINPresswire.com⁩/ -- Crescent Real Estate LLC (Crescent) used its investment fund, GP …

Reuben’s Brews Named a Rising Star in the 2019 Brewbound Awards

Seattle-based brewery recognized in national awards program SEATTLE, WASHINGTON, USA, December 5, 2019 /⁨EINPresswire.com⁩/ -- Reuben’s Brews, a family-owned and operated Pacific Northwest Brewery, has won a Rising Star Award at the annual …

Brewers Marketing Tapped by Rhode Island and Connecticut Brewer Guilds to Boost Economic Growth

The branded app will feature digital passport programs to increase customer engagement and loyalty. BOCA RATON, FL, USA, December 5, 2019 /⁨EINPresswire.com⁩/ -- Brewers Marketing, a developer of custom apps and web platforms for the craft beer …

Beef Market 2019- Global Industry Analysis, By Key Players, Sale, Trends, Segmentation And Forecast By 2026

Wiseguyreports.Com Adds “Beef – Global Market Sale, Growth, Opportunities, Analysis of Top Key Players and Forecast to 2026” To Its Research Database. PUNE, MAHARASTRA, INDIA, December 5, 2019 /⁨EINPresswire.com⁩/ -- Beef Market 2019-2026 …

Pickle Market 2019, Global Industry Analysis, Size, Share, Growth, Trends and Forecast - 2024

A New Market Study, titled “Pickle Market Upcoming Trends, Growth Drivers and Challenges” has been featured on WiseGuyReports. PUNE, MAHARASTRA, INDIA, December 5, 2019 /⁨EINPresswire.com⁩/ -- Summary A New Market Study, titled “Pickle Market …

Oat Drinks Market 2019- Global Industry Analysis, By Key Players, Segmentation, Trends And Forecast By 2025

Wiseguyreports.Com Adds “Oat Drinks– Global Market Sale, Growth, Opportunities, Analysis of Top Key Players and Forecast to 2025” To Its Research Database. PUNE, MAHARASTRA, INDIA, December 5, 2019 /⁨EINPresswire.com⁩/ -- Global Oat Drinks Market …

MINTEC NAMED WINNER IN FINAL OF THE EUROPEAN BUSINESS AWARDS 2019

Mintec Wins European Digital Technology Award at Prestigious European Business Award Ceremony in Warsaw BOURNE END, BUCKINGHAMSHIRE, UNITED KINGDOM, December 5, 2019 /⁨EINPresswire.com⁩/ -- Mintec from Bourne End in the UK has been named Winner of …

Non-Sugar Sweeteners Market: Size, Share and Growth Opportunities Outlook to 2024

The Global Non-Sugar Sweeteners Market is accounted to be $13.4 billion in 2014 growing at a CAGR of 1.67% to reach $15.3 billion by 2022. PUNE, MAHARASHTRA, INDIA, December 5, 2019 /⁨EINPresswire.com⁩/ -- Non-Sugar Sweeteners Industry …

Calcium Tartrate Market 2019 Global Industry Demand, Sales, Suppliers, Analysis and Forecasts to 2025

Wiseguyreports.Com Publish New Research Report On-“Calcium Tartrate Market 2019 Global Key Manufacturers Analysis, Sales, Supply, Demand and Forecast to 2025” PUNE, INDIA, December 5, 2019 /⁨EINPresswire.com⁩/ -- Calcium Tartrate Industry 2019 …

Supplements and Nutrition Packaging Market 2019 – Industry Analysis, Share, Growth, Sales, Trends, Supply, Forecast 2025

This report covers market characteristics, size and growth, segmentation, regional breakdowns, competitive landscape, market shares, trends and strategies PUNE, INDIA, December 5, 2019 /⁨EINPresswire.com⁩/ -- This report researches the worldwide …

Near-beer Market 2019 Global Industry, Demand, Sales, Suppliers, Analysis, Forecasts 2025

This report covers market characteristics, size and growth, segmentation, regional breakdowns, competitive landscape, market shares, trends and strategies PUNE, INDIA, December 5, 2019 /⁨EINPresswire.com⁩/ -- The global Near-beer market was valued …

Food Software Market By Services,Assets Type,Solutions,End-Users,Applications,Regions Forecasts to 2025

PUNE, INDIA, December 5, 2019 /⁨EINPresswire.com⁩/ -- WiseGuyReports.Com Publish a New Market Research Report On –“ Food Software Market By Services,Assets Type,Solutions,End-Users,Applications,Regions Forecasts to 2025”. Food Software …

Soybean Milk Market Research – Industry Analysis, Growth, Size, Share, Trends, Forecast to 2025

This report covers market characteristics, size and growth, segmentation, regional breakdowns, competitive landscape, market shares, trends and strategies PUNE, INDIA, December 5, 2019 /⁨EINPresswire.com⁩/ -- The global Soybean Milk market was …

Virtual Power Plant Market 2019- Global Industry Analysis, Size, Share, Growth, Trends and Forecast - 2025

WiseGuyReports.Com Publish a New Market Research Report On –“Virtual Power Plant Market 2019 – Global Sales,Price,Revenue,Gross Margin and Market Share”. PUNE, MAHARASHTRA, INDIA, December 5, 2019 /⁨EINPresswire.com⁩/ --  Report Overview: …

Food Waste Management Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2019 – 2024

WiseGuyRerports.com Presents “Food Waste Management Market Analysis - Global & Regional Industry Forecast (2019 - 2024)” New Document to its Studies PUNE, MAHARASTRA, INDIA, December 5, 2019 /⁨EINPresswire.com⁩/ -- This report …

Alcoholic Beverage Packaging Global Market Demand, Growth, Opportunities, Top Key Players and Forecast to 2025

WiseGuyRerports.com Presents “Global Alcoholic Beverage Packaging Market Professional Survey Report 2019” New Document to its Studies Database PUNE, MAHARASTRA, INDIA, December 5, 2019 /⁨EINPresswire.com⁩/ -- Alcohol Beverage Packaging …