The FDA warns that President Trump's much-touted coronavirus drugs could cause deaths. The White House says media 'irresponsibly' reported his words.

In a clinical trial, the drug remdesivir shortened recovery time for patients with advanced cases of COVID-19, the disease caused by the coronavirus.

Republican lawmakers, determined to punish China for concealing early data on the coronavirus outbreak, are proposing ways to turn up the heat.

Medicaid and other parts of the healthcare safety net get left behind in the Trump administration's plans for distributing aid to battle the coronavirus.

After trying to remain silent, the presumptive Democratic presidential nominee says the allegation of an assault dating to the 1990s 'isn't true.'

A week after Georgia Gov. Brian Kemp plunged Georgia into the middle of a national social experiment — rolling back restrictions on businesses in an effort to restart the economy after a monthlong shutdown to halt the spread of COVID-19 — some restaurants, salons and tattoo parlors remain shuttered. Most that are opening are proceeding cautiously.

The coronavirus pandemic is threatening Mexico's fragile public health infrastructure.

Rick Bright, pushed out of a job heading a federal research agency, files a complaint saying he was retaliated against for resisting Trump's plans.

As states lift coronavirus restrictions, none has met federal benchmarks, a health expert warns. The COVID-19 death toll in the U.S. surpasses 73,000.

Mother's Day weekend will be summery in California and wintery with snow in parts of the East

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It might be all about moms this weekend, but it seems like we need to make some room for the next generation to shine too! These mamas have been sharing some sweet snaps of their matching moments with their babes ... and these cuties might just be…

Queens of the Stone Age front man Josh Homme is flipping the script on his estranged wife, whom he claims has been trying to get him busted for allegedly violating a restraining order. Now the rock singer's filed for a restraining order against…

YouTube superstar-turned-fighter Jake Paul says he'll beat the living daylight out of MMA fighter Dillon Danis in a boxing match ... and tells TMZ Sports he has a UFC superstar on board to help him get it done. Of course, Paul previously stated he…

This is kinda shocking, but Carnival Cruise enthusiasts aren't letting the pandemic scare 'em away from boarding ships with hundreds of passengers. A rep with Cruise Planners, an American Express travel franchise, tells TMZ ... after Carnival…

The ITV host told his Twitter followers on Sunday night that he had been feeling unwell over the weekend

June and her late husband Leon were among the original stars of the Channel Four reality show

The Corrie favourite has stunned fans with his new look after taking up running

With 34 years of programming experience in various organizations, Cal shares what he's observed of leaders who are looking to be reinvigorated, what to do when job-inspiration is lost and taking an educated leap of faith.

Keep on reading: Quick Answers to Quick Questions: In Conversation with Cal Evans, Senior Consultant, E.I.C.C., Inc.

By Jennifer A. Davidson and Justine E. Johnson On February 21, 2020, FDA published a final rule that, effective March 23, 2020, amends the regulatory definition of “biological product” consistent with the statutory definition under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), as amended by the Further Consolidated Appropriations Act, 2020 (FCAA),

The post FDA AMENDS THE DEFINITION OF “BIOLOGICAL PRODUCT” AND PREPARES FOR THE CONCLUSION OF A DECADE-LONG TRANSITION PERIOD appeared first on Kleinfeld Kaplan & Becker LLP.

By: Stacy Ehrlich and Justine E. Johnson On March 18, 2020, the Food and Drug Administration (FDA) published a final rule (21 C.F.R. Part 1141) requiring textual and graphic health warnings to be included on all cigarette packages and advertisements.[1]  FDA simultaneously published two related guidance documents: (1) Required Warnings for Cigarette Packages and Advertisements,

The post FDA ISSUES FINAL RULE ON GRAPHIC WARNINGS FOR CIGARETTE PACKAGES AND ADVERTISEMENTS appeared first on Kleinfeld Kaplan & Becker LLP.

By: Daniel Dwyer and Daniel Logan On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act, or “CARES” Act (Pub. Law 116-136), which includes a comprehensive revision of the rules governing over-the-counter (OTC) drugs currently marketed under monographs published by the Food and Drug Administration (FDA).  This law

The post New Opportunities for OTC Monograph Drugs under the CARES Act appeared first on Kleinfeld Kaplan & Becker LLP.

#TTB just made changes to modernize the way that #wine, #distilledspirits, and #maltbeverages are labeled and advertised. KKB associate Dan Logan and partner Dan Dwyer highlight some of the key changes (and proposals that were rejected).

The post TTB Finalizes Portions of Modernization of Advertising and Labeling Regulations for Wine, Distilled Spirits, and Malt Beverages Rule appeared first on Kleinfeld Kaplan & Becker LLP.

Researchers at Purdue University have developed a new technique to dramatically enhance the resolution achievable when imaging intracellular structures with super-resolution fluorescence microscopy. The technique uses the distortions created by a specimen to pinpoint the location of individual molecules, and thereby infer the location of intracellular structures. The technique could be particularly useful in studying […]

LifeSignals, based in Fremont, California, announced that it received the CE Mark for its LifeSignals ECG Remote Monitoring Patch. The patch, integrated with a remote monitoring platform, is designed as a continuous electrocardiography (ECG) and heart rate monitor. The ECG Remote Monitoring Patch is disposable and captures data for up to three days. The device […]

VitalConnect announced that it has received FDA Emergency Use Authorization status for use of its VitalPatch to detect changes in the QT interval of hospitalized patients undergoing drug treatment for COVID-19. Hydroxychloroquine and chloroquine, used to treat some COVID-19 patients, are associated with risk of prolonged QT interval that can lead to life-threatening arrhythmias. VitalPatch allows […]

Adhesives specialist Intertronics has launched the preeflow eco-DUOMIX, a system that mixes and dispenses two-part materials.

Tom Hoover, senior medical business development manager – Americas, assembly technologies, at global technology and manufacturing company, Emerson, explains how ultrasonic plastic welding is improved through improved force control.

Greenlight Guru, a Medical Device Quality Management Software (MDQMS) platform, has teamed up with Emergo by UL, a consulting firm specialising in global medical device regulatory compliance.

Engineers from the University of Glasgow are responding to the coronavirus pandemic by producing up to 1,000 pieces of Personal Protective Equipment (PPE) each day.

Health news and commentary from around the Web gathered by the ALLMedPage Today staff

Health news and commentary from around the Web gathered by the ALLMedPage Today staff

Health news and commentary from around the Web gathered by the ALLMedPage Today staff

Health news and commentary from around the Web gathered by the ALLMedPage Today staff

Get the inside information on what industry does and does NOT want from their academic counterparts: Join us June 16, 3-4 p.m. EDT for Insider’s Guide to Effective Partnering at BIO 2011, a FREE AUTM webinar to help you prepare for the BIO convention in Washington, DC, June 27-30.

The move will establish Menarini's presence in the US biopharma market

The guideline is designed to help healthcare professionals who are not kidney specialists to prevent, detect and manage AKI in hospitalised patients with suspected or confirmed COVID-19

The Scottish government has given funds £101,903 to support the project