FDA News Monitoring

Crisis medicine: Potential COVID-19 treatments that lack FDA approval

by Niko Kyriakou Editor’s note: This story offers an alternative look at possible COVID-19 treatments, drawing on the widely varying perspectives of local practitioners and global experts. COVID-19 has spawned a billion-dollar race to research and develop …

FDA Publishes List of Essential Medicines, Medical Countermeasures, Critical Inputs Required by Executive Order

For Immediate Release: October 30, 2020 Statement From: Statement Author Leadership Role Commissioner of Food and Drugs - Food and Drug Administration Stephen M. Hahn M.D. As the U.S. Food and Drug Administration continues our work to address the current …

NMPF: FDA Must Enforce Fake-Dairy Rules

NMPF: FDA Must Enforce Fake-Dairy Rules USAgNet - 10/30/2020 With FDA giving little indication of promised action on proper labeling of imitation dairy products, the National Milk Producers Federation asked the agency's ombudsman to ensure that …

OliX Pharmaceuticals Announces FDA Clearance of the IND to Evaluate the Efficacy of OLX10010 in Phase 2a Clinical Trial ...

Potential first-in-class treatment for hypertrophic scars with no FDA-approved medicines to to-date Phase 2a trial follows the successful completion of OliX’s Phase 1 trial in the U.K. in November 2019 OliX retains global rights to develop and …

Nexus Pharmaceuticals wins FDA approval for Succinylcholine Chloride Injection, USP

Healthcare company Nexus Pharmaceuticals reported on Thursday the receipt of approval from the US Food and Drug Administration (FDA) for Succinylcholine Chloride Injection, USP in 200mg/10ml Multiple-Dose Vials. Succinylcholine Chloride Injection, USP …

FDA studying Aussie pharma firm’s bid for COVID-19 vaccine clinical trials

The country’s vaccine experts panel is currently evaluating the application of an Australian pharmaceutical firm to conduct clinical trial Phase 3 for its COVID-19 candidate vaccine in the Philippines. Food and Drug Administration (FDA) Director-General …

Avoid Inovio Pharmaceuticals Stock Until the FDA Greenlights Trials

I’ll put this as simple as possible: avoid Inovio Pharmaceuticals (NASDAQ:INO). There are far better opportunities to be found in companies nearing late-stage vaccine results. With INO stock, it’s like watching paint dry. Source: Ascannio / …

There will be no more smuggling of unwholesome products – FDA assures

The Food and Drugs Authority has assured that smugglers of unwholesome goods into the country would be unsuccessful henceforth. The entity maintains that necessary structures have been put in place to safeguard the health of Ghanaians right from the ports …

Stock Alert: Equillium Up 14% After FDA Clears COVID-19 Trial Of Itolizumab

Shares of Equillium, Inc. (EQ) are gaining more than 14 percent or $0.86 in Friday's morning trade at $6.86. Thursday, Equillium said it has received FDA clearance to commence a phase III clinical trial of Itolizumab in hospitalized COVID-19 patients …

FDA gives green signal to Equillium's late-stage COVID-19 trial

COVID-19 vaccine trials at point where FDA OK may be sought in November

Late-stage trials of a COVID-19 vaccine are expected to be far enough along by November for biotech company Moderna to seek Food and Drug Administration approval for the vaccine’s emergency use, the lead investigator for trials in Las Vegas said late …

Palace warns vs COVID-19 vaccines being sold without FDA approval

Malacañang issued a warning against those who are selling what is supposed to be a vaccine for COVID-19, saying there is a punishment for those who will sell drugs not approved by the Food and Drug Administration (FDA). Presidential spokesman Harry Roque …

Remdesivir received FDA approval for treating COVID-19 patients: Benefits still not proven

Reviewed by Emily Henderson, B.Sc.Oct 29 2020 The United States has become the epicenter of the world in the ever increasing pandemic of COVID-19. While public health prevention strategies of social distancing, crowd avoidance, masking and frequent hand …

Nexus Pharmaceuticals Receives FDA Approval for Succinylcholine Chloride Injection, USP

LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Oct 29, 2020-- Nexus Pharmaceuticals announced it has received U.S. Food and Drug Administration (FDA) approval for Succinylcholine Chloride Injection, USP in 200mg/10mL Multiple-Dose Vials. It is an AP-rated …

Remdesivir for COVID-19: FDA Approved but Still Unproven

Newswise — The United States has become the epicenter of the world in the ever increasing pandemic of COVID-19. While public health prevention strategies of social distancing, crowd avoidance, masking and frequent hand washing are of proven benefit, …

Equillium Receives FDA Clearance of COVID-19 IND for Phase 3 Trial

Equillium plans to initiate global Phase 3 COVID-19 trial – EQUINOX – during Q4 2020 FDA indicates study could support BLA filing LA JOLLA, Calif., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company …

The FDA Will Not Inspect Vaccine Production Plants

ZOETERMEER, NETHERLANDS - OCTOBER 27: View of influenza vaccine syringes at a general practitioner's ... [+] office on October 27, 2020 in Zoetermeer, Netherlands. The demand for flu vaccines is so high there is currently a shortage. The Dutch …

Roche receives FDA approval for the cobas EGFR Mutation Test v2 as the first companion diagnostic test for expanded EGFR ...

Diagnostics Oncology FDA  News Release - October 29, 2020 Lung cancer causes more than 1.7 million deaths worldwide each year, with NSCLC accounting for about 85 percent of all cases[1] The cobas EGFR Mutation Test v2 is FDA approved as a companion …

Vanda ‘optimistic’ after Q3 sales bump, good news from FDA on new eye inflammation drug

Rainbow Restaurant gets creative in continuing to serve the Fort Collins community in the face of the COVID-19 pandemic

Family-owned eatery offers carry-out and delivery service, while also providing hundreds of meals to homeless individuals and front-line workers FORT COLLINS, COLORADO, UNITED STATES, October 30, 2020 /⁨EINPresswire.com⁩/ -- Fort Collins, Colorado …

Irish Entrepreneur to Launch Ireland Loves Baking & Plans to Take A Slice of the € 85m Baking Market

The team behind Britain Loves Baking to launch a digital popup store dedicated to Irish bakers www.irelanlovesbaking.com tomorrow the 31st DUBLIN, IRELAND, October 30, 2020 /⁨EINPresswire.com⁩/ -- Britain Loves Baking, a direct to customer online …

Z-SC1 Corp. Offers Low-Temperature and Ultra-Low Temperature Freezers for Safe COVID-19 Vaccine Transport

Meeting up to the challenge set by the pandemic, Z-SC1 Corp. ramps up its manufacture and production of Low-Temperature and Ultra-Low Temperature Freezers WILMINGTON, DE, USA, October 30, 2020 /⁨EINPresswire.com⁩/ -- Z-SC1 Corp. is an …

Class Action Filed Against Zosano Pharma Corporation – Kehoe Law Firm, P.C. Investigating Securities Claims

Investors Who Purchased Or Acquired ZSAN Securities During The Class Period And Suffered Losses Greater Than $50K Encouraged To Contact Kehoe Law Firm, P.C. CALIFORNIA, USA, October 30, 2020 /⁨EINPresswire.com⁩/ -- Kehoe Law Firm, P.C. continues …

Dried Pasta Sauce Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2020 – 2026

Latest Market Analysis Research Report on “Global Dried Pasta Sauce Market 2020” has been added to Wise Guy Reports database. PUNE , MAHARASHTRA, INDIA, October 30, 2020 /⁨EINPresswire.com⁩/ -- Global Dried Pasta Sauce Industry New Study …

The Hollaender Manufacturing Company Helps Restaurants in New York City Solve Social Distancing Dilemma

Outdoor space has become a lifeline for restaurants and businesses due to COV-19, and has provided an opportunity to transform streetscapes and public spaces. CINCINNATI, OH, UNITED STATES, October 30, 2020 /⁨EINPresswire.com⁩/ -- On Monday, …

Protein Supplement Market size is growing at a CAGR of 7.4% from 2018 to 2025

The demand for protein supplements from the young population is increasing mainly in athletes as they provide various benefits such as improving immunity. PORTLAND, OR, UNITED STATES, October 30, 2020 /⁨EINPresswire.com⁩/ -- According to a new …

$75,000 OTF Grant Expanded Second Harvest’s Training and Education Program

TORONTO, Oct. 30, 2020 (GLOBE NEWSWIRE) -- To mark the successful launch of its online food waste reduction eLearning modules, last Friday Second Harvest welcomed the public to a Zoom-hosted event, “Tackling Food Waste from Field to Fork” – studying the …

Plant-Based Diet Changes Life of Homeless Man and Encourages Him, Martez House, to Launch Official Wealth Brand to Help ...

Los Angeles, CA, Oct. 30, 2020 (GLOBE NEWSWIRE) -- Martez House is currently living the American dream. Not only is he a proud father and family man, but he is an entrepreneur and owner of a brand that changes people’s lives for the better. The Official …

World's Largest Barbecue Franchise Heads Down Under

Dallas, TX, Oct. 30, 2020 (GLOBE NEWSWIRE) --  This week, 79-year-old barbecue franchise Dickey’s Barbecue Pit set their sights on expanding their international presence by entering a letter of intent with Australian restaurant group QSR Foods Pty LTD. to …

High-End NYC Restaurant Chooses Key Digital AV over IP and Compass Control Pro to Create the Perfect Atmosphere

Mount Vernon, New York, Oct. 30, 2020 (GLOBE NEWSWIRE) -- Situated on 28 acres of New York City’s prime real estate in the Chelsea and Hudson Yards neighborhoods of Manhattan, the Hudson Yards development imposes an impressive presence. The site is home to …

Celebrating Food Industry EPA GreenChill Award Winners

Oct 30, 2020 By: Marjorie DePuy, Senior Director, Supply Chain and Sustainability and Farleigh Lichstein, Director, Education FMI In a typical year, the FMI Energy & Store Development Conference would feature a special presentation of the Environmental …

FDF Cymru announced as AMRC Cymru partner as part of WGov business outreach programme

30 October 2020 Back to list of articles FDF Cymru announced as AMRC Cymru partner as part of WGov business outreach programme FDF Cymru, which represents Welsh food and drink manufacturers, has been announced as a partner to the University of Sheffield …

Constellation Brands Announces Full Redemption of Senior Floating Rate Notes Due 2021

VICTOR, N.Y., Oct. 30, 2020 (GLOBE NEWSWIRE) -- Constellation Brands, Inc. (NYSE: STZ and STZ.B), a leading beverage alcohol company, announced today that it has given notice for full redemption prior to maturity of all of its outstanding Senior Floating …

Monster Beverage Announces James Dinkins as New Director, Following Replacement in Designee of The Coca-Cola Company

CORONA, Calif., Oct. 30, 2020 (GLOBE NEWSWIRE) -- Monster Beverage Corporation (NASDAQ:MNST) today announced that James L. Dinkins will join its board of directors as the new designee of European Refreshments (an indirect wholly-owned subsidiary of The …

North American Air Compressor Rental Market Expected To Recover After 2021

Spending in construction, manufacturing recovery, the continuing shift from ownership to rental, and aging refining facilities are major drivers. SAN ANTONIO, TX, UNITED STATES, October 29, 2020 /⁨EINPresswire.com⁩/ -- A new analysis by Verify …

QuadGrill: The Launch

Advancing The Evolution of Wood Charcoal Cookery With QuadGrill DECATUR, GA, UNITED STATES, October 29, 2020 /⁨EINPresswire.com⁩/ -- There is nothing quite like the experience of friends and family at a wood char grilling event taking in the …

Dami’s Famous Foods re-releases the eBook, “Eat Good, Feel Good” on multiple electronic publishing platforms

The eBook is a collection of healthy recipes that provides readers with increased knowledge about healthy food choices that fit into any diet or meal plan. LOS ANGELES, CALIFORNIA, UNITED STATES, October 29, 2020 /⁨EINPresswire.com⁩/ -- Locally …

Cocoa Products Market Overview, Trends and Growth Opportunities By 2026 Revenue $30.2 Billion

The increase in demand from confectionery, and food & beverages industries has fueled the growth of the cocoa products industry. PORTLAND, OR, UNITED STATES, October 29, 2020 /⁨EINPresswire.com⁩/ -- Cocoa Products Market by garnered $24.5 …

Plexure named in 2020 Gartner Magic Quadrant for Mobile Marketing Platforms

Plexure Group (NZX:PLX) has been positioned as the highest for ‘Ability to Execute and furthest for ‘Completeness of Vision’ in the Niche Player quadrant. Plexure (NZX:PLX) AUCKLAND, NEW ZEALAND, October 29, 2020 /⁨EINPresswire.com⁩/ -- Plexure …