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FDA issues warning about fecal transplants

Fighting C. difficile with antibiotics is often a losing battle, but fecal transplant is novel treatment with FDA warning.



  • Fitness & Well-Being

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FDA cracks down on green tea products

Is drinking a high-fructose corn syrup sweetened soft drink a great way to get extra antioxidants in your diet? The FDA thinks not.



  • Fitness & Well-Being

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High fructose corn syrup is not sugar, says FDA

Food and Drug Administration denies the Corn Refiners Association's request to change the name of the famous syrup to corn sugar.




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Most parents ignore FDA warnings about cold medicine

New survey finds that 40 percent of parents disregard warning labels and give cough and cold medicine to young kids.



  • Babies & Pregnancy

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FDA reduces arsenic levels in apple juice

The Food and Drug Administration is lowering the current acceptable amount of arsenic in apple juice from 23 parts per billion to 10.




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FDA sets limits for arsenic in apple juice

Apple juice will now have the same standards as water when it comes to the amount of arsenic allowed, but how much praise does the FDA deserve?




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FDA sets new rules on gluten-free foods

People with celiac disease can now trust that foods labeled "gluten-free" are safe for them to eat.




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No FDA recall on jerky treats killing hundreds of pets

Almost 600 dogs have died and thousands more have fallen ill in an outbreak linked to jerky treats made in China.




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FDA aims to curb painkiller abuse

The FDA recommends reducing the number of refills for popular narcotic painkillers, and requiring that doctors write a prescription.



  • Fitness & Well-Being

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FDA moves to make pet and animal food safer

FDA issues a proposal to improve food safety for animals. Proposed rule would require producers of treats, blamed for pet deaths, to meet new requirements.



  • Protection & Safety

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Magnet treatment device for migraines approved by FDA

The use-at-home device that treats migraines with a pulse of magnetic energy has shown significant promise in clinical trials.



  • Fitness & Well-Being

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FDA: Companies that make antibacterial soap must prove that it's safe

The Food and Drug Administration has issued a proposal that would require makers of soaps to show that their products really work.



  • Fitness & Well-Being

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Some wart removers are flammable, FDA warns

Some wart removers are highly flammable, and consumers should not use them around any source of heat.



  • Protection & Safety

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FDA's new anti-smoking campaign aimed squarely at kids

The Food and Drug Administration is launching its first national campaign to prevent and reduce smoking among young people.



  • Fitness & Well-Being

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FDA proposes new nutrition labels for food

New labels would focus on sugar and calories and reflect a realistic serving size for the American diet.




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Is the FDA going to take away our wood-aged artisanal cheese?

The FDA issued a statement, and then a clarification about that statement, about aging cheese on wood. What does it mean?




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Acne products can cause harmful side effects, FDA warns

Some over-the-counter acne treatments can trigger serious and potentially life-threatening allergic reactions in rare cases




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FDA can ignore taking action on overuse of antibiotics in livestock if it wants, says court

Even if the FDA knows something is harmful, it seems no one can make them do anything about it.




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FDA suggests allowing blood donations by gay men — but of course there's a catch

Advocacy groups call the new recommendation arbitrary and discriminatory.




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FDA points finger at calories from added sugar

FDA floats proposal that would set 10% of total calories as the standard. So, if you drink a 16-ounce soda, you're done.




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FDA to finally tackle 'natural' food label

This is your chance to add your voice to the mix as the agency looks into what the label means.




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FDA approves GMO salmon for consumption

Genetically modified salmon will now be sold in stores and restaurants, and it doesn't have to be labeled.




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Groups sue FDA over GMO salmon

A coalition of plaintiffs hit the FDA with a lawsuit saying it did not consider environmental risks when it approved the genetically modified fish.




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FDA to test foods for glyphosate residue

Alliance for Natural Health-USA released tests on breakfast foods, and glyphosate was found in 11 of 24 samples. WHO says the chemical is probably carcinogenic.




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Nutella asks FDA to say it's not dessert

The makers of the mostly chocolate and sugar product want it reclassified. The FDA wants to know what the public thinks about that.




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FDA to scrutinize risky homeopathic products

The FDA has announced that it's cracking down on homeopathic products, especially ones for children and infants.



  • Fitness & Well-Being

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Glyphosate residue found in FDA-tested honey

Weed killer glyphosate is being carried by foraging bees back to their hives — even organic bee hives.




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Unpaid FDA inspectors tackle high-risk facilities as shutdown continues

The government shutdown has forced the Food and Drug Administration to significantly reduce the number of inspections it's able to do.



  • Protection & Safety

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Why doesn't the FDA have more control over the safety of beauty products?

FDA issues rare warning after 21,000 people suffer an adverse reaction to Wen hair care product.



  • Fitness & Well-Being

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Lab animals can now be adopted, FDA says

A new policy allows research animals at the Food and Drug Administration (FDA) to be adopted into forever homes when their experiments end.




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Teeter Inversion Tables and Decompression Devices Cleared by the FDA

Indicated for an Expanded List of Back Pain Related Conditions




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Corporate Whistleblower Center Now Urges a Pharmaceutical Company Manager to Call About Rewards If They Have Proof Their Employer Is Hiding Information About a Defective Drug To Consumers or FDA

According to the Corporate Whistleblower Center, "If you work for a drug maker that is concealing extremely vital information about severe side effects regarding their product from consumers and the FDA-please call us at 866-714-6466 about rewards."




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Corporate Whistleblower Center Now Urges a Medical Device/Product Employee to Call Them About Huge Rewards If They Can Prove Their Employer Is selling Dangerous Devices-Without Notifying the FDA

The Corporate Whistleblower Center says, "If you work for a medical device/products company and your employer's product is defective-please call us at 866-714-6466 and hopefully get rewarded for what you know-and be a hero for consumers."




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Haleigh's Hope, Inc. Lab Receives FDA Compliant, GMP Certification on Manufacturing Practices for All Hemp CBD Products Manufactured by the Company

Haleigh's Hope is proud to announce that they received GMP (Good Manufacturing Practices) certification.




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FDA Clears New Mechanical Thrombectomy Platform

New large catheter platform FDA cleared to remove blood clots from peripheral vessels




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FDA approves Eli Lilly drug for thyroid, lung cancers driven by a genetic mutation




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U.S. FDA grants emergency use authorization to Quidel for first antigen test for COVID-19

(Reuters) - The U.S. Food and Drug Administration (FDA) on Saturday approved emergency use authorization (EUA) to Quidel Corp for the first COVID-19 antigen test. The emergency use authorization was issued late Friday to Quidel for the Sofia 2 SARS Antigen FIA, the agency said.

The post U.S. FDA grants emergency use authorization to Quidel for first antigen test for COVID-19 appeared first on Firstpost.




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FDA Okays Historic Blood Treatment for COVID; Clinical Trials to Use Antibodies From Recovered Patients

New York's Gov. Andrew Cuomo plans to pursue the treatment following its relative success in treating influenza and Ebola.

The post FDA Okays Historic Blood Treatment for COVID; Clinical Trials to Use Antibodies From Recovered Patients appeared first on Good News Network.




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FDA’s Graphic Cigarette Warnings Show and Tell the Deadly Truth About Smoking – They Must Be Fully Implemented and Vigorously Defended

WASHINGTON, D.C., March 17, 2020 – By issuing a final rule requiring large, graphic health warnings on cigarette packs and advertising, the U.S. Food and Drug Administration today has taken a critical and long-overdue step forward in the nation’s battle...




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FDA review of e-cigarettes is as critical as ever – any delay related to COVID-19 must be brief

WASHINGTON, D.C., April 1, 2020 – After years of harmful delays by the FDA, a federal judge last July set a May 12, 2020, deadline for e-cigarette manufacturers to apply to the FDA and demonstrate a public health benefit in order to keep their products...




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La revisión de cigarrillos electrónicos por parte de la FDA es más importante que nunca: cualquier retraso relacionado con COVID-19 debe ser breve

WASHINGTON, D.C., 1 de abril del 2020 – Después de años de demoras perjudiciales por parte de la FDA, en julio del año pasado un juez federal estableció como fecha límite el 12 de mayo del 2020 para que los fabricantes de cigarrillos electrónicos...




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FDA Cracks Down on CBD COVID Claims

Small, little-known companies are selling CBD as a cure-all. While the Trump Administration has deregulated right and left — for instance, allowing polluters to go hog wild — the Food and Drug Administration isn't effing around when it comes to cracking down on companies selling supposed cures for the COVID-19 virus. Several of those targeted companies make CBD.…




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Stock Alert: Pluristem Shares Up 24% In Premarket On FDA Clearance News

Shares of Pluristem Therapeutics Inc. (PSTI) are rising over 24% in pre-market today, after the company announced that the U.S. FDA has cleared the company's Investigational New Drug or IND application for a Phase II study of its PLX cells in the treatment of severe COVID-19 cases complicated by Acute Respiratory Distress Syndrome or ARDS.




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FDA Approves RedHill's COVID-19 Clinical Study With Opaganib; Stock Up 9%

Shares of RedHill Biopharma Ltd. (RDHL) are moving up over 9% in pre-market today, after the company announced that the U.S. FDA has approved its Investigational New Drug or IND application for a Phase 2a clinical study evaluating its investigational drug, opaganib, in patients with confirmed moderate-to-severe SARS-CoV-2 infection, the cause of COVID-19.





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N.Y. Cases at Seven-Week Low; FDA Head Quarantined: Virus Update

(Bloomberg) -- New York reported the fewest new coronavirus cases in seven weeks. The first antigen test won U.S. approval for emergency use. The federal government reversed course and will let states distribute remdesivir to hospitals.Italy had the fewest cases in four days. Germany and Spain are ready to lift some restrictions. Russia’s largest gold mine in Siberia has 89 sick workers as the nation registered more than 10,000 infections for a seventh day.The head of the U.S. Food and Drug Administration is in a two-week quarantine after coming into contact with an infected person.Key Developments:Virus Tracker: cases pass 3.9 million; deaths exceed 276,000Half-empty bar feels like a win after Georgia reopensBrazil is new virus hotspot as infections triple in two weeksMass shootings in the U.S. have plungedLessons from Ebola prepared Africa for coronavirusAuto industry to raise $100 billion from banks for virus reliefSubscribe to a daily update on the virus from Bloomberg’s Prognosis team here. Click VRUS on the terminal for news and data on the coronavirus. See this week’s top stories from QuickTake here.Musk: Tesla to Quit California (1 p.m. NY)Elon Musk said on Twitter he is moving Tesla’s headquarters and future programs to Texas and Nevada “immediately” after a California county blocked plans to open an assembly plant shut during the pandemic.He had earlier tweeted he was suing Alameda County for “acting contrary to the Governor, the President, our Constitutional freedoms & just plain common sense!” The county on Friday said Tesla’s sole U.S. plant in Fremont, California, didn’t meet the criteria to reopen. Musk told staff he aimed to restart the factory Friday.Canada Gets China Medical Gear (12:50 p.m. NY)Canada is securing large amounts of personal protective equipment on daily flights of goods from China and elsewhere, Prime Minister Justin Trudeau said.So far, about 23 flights from China have brought millions of PPE items. In order to gradually restart the economy, Canada needs enough equipment to ensure people can work in safe environments, he said. Equipment arriving from other countries will be tested before being sent out to front-line workers.Africa Seeks Debt Relief, Stimulus (12:40 p.m. NY)African nations needs a two-year debt standstill to give governments the fiscal space to fight the pandemic, South African President Cyril Ramaphosa said.A $100 billion injection of emergency economic stimulus is also required to combat the impact of the disease and almost half of that could come from waiving interest payments, according to the United Nations Economic Commission for Africa.African finance ministers are discussing debt-relief proposals, including a special-purpose vehicle to exchange their sovereign debt for new concessional paper to avoid having to use funds needed to battle the virus to pay private creditors.Italy Has Fewest Cases Since May 5 (12:20 p.m. NY)Italy registered 1,083 new cases on Saturday -- the fewest since May 5 -- compared with 1,327 a day earlier. Confirmed cases now total 218,268. Daily fatalities fell to 194 from 243 on Friday, with a total of 30,395.With the government cautious on easing measures after an initial relaxation on Monday, an Ipsos survey published in newspaper Corriere della Sera on Saturday showed 58% of Italians want all economic sectors to restart as soon as possible.N.Y. Has Fewest Cases in 7 Weeks (11:50 a.m. NY)New York reported 572 new infections on Saturday, the fewest since late March, which Governor Andrew Cuomo called “welcome news.” The state reported 2,938 infections on Friday.New deaths were 226, the same as five days ago and an increase from 216 reported on Friday. The rate of hospitalizations fell again.FDA Chief in Self-Quarantine (11:45 a.m. NY&)Food and Drug Administration Commissioner Stephen Hahn has quarantined himself after coming into contact with someone who tested positive. Hahn, a member of the White House virus task force, notified staff of his decision in a note Friday, according to an emailed statement from the agency.“Per CDC guidelines, he is now in self-quarantine for the next two weeks,” the FDA said. “He immediately took a diagnostic test and tested negative.”The FDA didn’t identify the infected person, but Hahn’s Covid-19 exposure comes as several aides working in the White House have the virus. Vice President Mike Pence’s press secretary, Katie Miller, tested positive Friday, a day after a positive test was reported for a member of the military who works as a valet to President Donald Trump.U.K. Urges Cycling, Walking (11:30 a.m. NY)The U.K., the European country hardest hit by the outbreak, plans to spend 2 billion pounds ($2.5 billion) to encourage people to cycle and walk to work and help relieve pressure on transport systems.Prime Minister Boris Johnson has said that the U.K. has passed the peak of the outbreak, and limiting travel on public transit will help curb the risk of a second wave of infections, said Transport Secretary Grant Shapps. The government will also spend more on electric-car charging points and extend trials of e-scooters and permit their rentals.Daily deaths rose by 346, Shapps said Saturday, down from 626 on Friday and the lowest since May 4. Total deaths reached 31,587, surpassed only by the U.S., with total infections at 215,260.U.S. Can’t Wait for End of Outbreak: Carson (11:25 a.m. NY)America’s economic infrastructure could be destroyed if the nation waits too long to reopen closed businesses, said White House coronavirus task force member Ben Carson, who also is secretary of Housing and Urban Development.The nation has to learn to live with the coronavirus before it can be eradicated, Carson said on Fox News. “If we wait until it’s all gone before we come out, our economy will be gone also.”Carson, who also heads the president’s revitalization council, stressed that it’s possible to resume activity, guided by “data and evidence” from regions that reopened first.Collapse of Travel Demand Scuttles Deal (10:50 a.m. NY)Carlyle Group Inc. and Singapore sovereign-wealth fund GIC Pte. Ltd. are backing out of a deal to buy a stake in American Express Global Business Travel, hit hard by the pandemic. The parties were in talks on terms of the deal, which was set to close this week, but couldn’t reach an agreement, people familiar with the matter said. The deal valued the American Express Co. unit at $5 billion with debt.U.S. Ships Gilead’s Drug to States (10:40 a.m. NY)The U.S. is sending Gilead Sciences Inc.’s remdesivir to Connecticut, Illinois, Iowa, Maryland, Michigan and New Jersey after doctors raised questions about the federal allocation of the drug to treat Covid-19 patients.State health agencies -- rather than the federal government -- will distribute doses to the hospitals, the Department of Health and Human Services said Saturday. Illinois and New Jersey each get more than 100 cases, with the other states receiving from 10 to 40 cases. Each case has 40 vials.After remdesivir won U.S. approval for emergency use, the federal government said it would decide which hospitals got the drug. Doctors then raised questions about the opaque process for getting the therapy to U.S. hospitals.FDA Clears Antigen Test (9:39 a.m. NY)The FDA issued the first emergency use authorization for a Covid-19 antigen test. The diagnostic tests quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs, Quidel Corp. said in a statement that linked to a letter from the FDA. The authorization was issued late Friday for its Sofia 2 SARS Antigen FIA.Belarus Holds Military Parade, Russia Cancels (9:30 a.m. NY)Alexander Lukashenko, the authoritarian president of Belarus, defied warnings about the risks of letting the coronavirus spread by holding a military parade marking victory in World War II.Amid an average of about 800 new infections a day, Lukashenko summoned troops to the capital, Minsk, for the parade. Neighboring states including Russia changed their plans as gatherings of thousands of spectators will inevitably spread the disease.Portugal Cases Moderate (9:12 a.m. NY)Portugal reported the smallest increase in new confirmed cases in six days and the number of patients in intensive care units fell for a third day. There were 138 new cases in a day, taking the total to 27,406, the government said. The total number of deaths rose by 12 to 1,126.Information is “encouraging” after the country allowed some small stores to reopen on Monday, Health Minister Marta Temido said at a press conference on Saturday.Germany Plans Stimulus for Arts, Cities (7:30 a.m. NY)Germany will broaden its economic aid, the Tagesspiegel newspaper cited Finance Minister Olaf Scholz as saying in an interview.“The arts and culture need their own stimulus program, we want to massively help people here,” Scholz said. “We also have to do something for hotels and restaurants, which are severely weakened. Thirdly, the municipalities also need massive support.”Germany will also have to pursue an “incredible modernization push” in order to maintain and expand its wealth without using fossil fuels, the newspaper cited Scholz as saying.Saudi Arabia Relaxes Some Restrictions (7:12 a.m. NY)Saudi Arabia is relaxing restrictions on six neighborhoods in Medina, state-run Saudi Press Agency reported on Saturday, citing an official at the Ministry of Interior. Movement will be unrestricted from 9 a.m. until 5 p.m.The Saudi government has reported 35,432 cases including 229 fatalities. It has imposed a 24-hour lockdown and said it will fine and jail those who violate the rules. The kingdom has eased restrictions on some areas in recent weeks.Russia’s Biggest Gold Mine Has 89 Cases (6:53 a.m. NY)Almost 90 workers at Russia’s largest gold mine, operated by Polyus PJSC, have contracted the coronavirus, the state-run Tass news service reported, citing the public health agency.The Olimpiada mine in the Siberian province of Krasnoyarsk recorded 82 new cases of the deadly virus in the past day, Tass cited the press service of the regional branch of Rospotrebnadzor as saying.Earlier, Russia said its number of new infections rose by 10,817 to 198,676, the seventh straight day cases have risen by more than 10,000.Spain Continues Unwinding (5:50 p.m. HK)Spain reported 179 coronavirus deaths in the past 24 hours, according to health ministry data. The country reported 604 new daily cases as the total number rose to 223,578.As of Monday, 51% of the Spanish population will move to the so-called phase 1 as limitations are relaxed across wide swathes of the country. A major exception is the Madrid region, the epicenter of Spain’s coronavirus outbreak.Under phase 1, shops of a size of less than 400 square meters will be able to open with restrictions while bars and restaurants will be able to operate “terraces” but with only 50% of their previously authorized number of tables, according to a government order published in the official gazette. Hotels can open but their public areas will stay closed.Indonesia Reports Most Cases in a Day (5:44 p.m. HK)Indonesia reported an increase in new cases, with the death toll nearing 1,000 as the world’s fourth-most populous nation struggles to contain the spread of the virus.Tests confirmed 533 new infections in the past 24 hours, taking the total to 13,645, Achmad Yurianto, a spokesman for the government task force on Covid-19, said at an online briefing on Saturday. Sixteen patients succumbed to the virus, taking the overall number of fatalities to 959, the third highest in Asia after China and India, according to data from Johns Hopkins University.Faroe Islands Free of Virus (5:30 p.m. HK)The Faroe Islands is now free of the coronavirus after all its 187 confirmed cases were declared to be healthy, the North Atlantic archipelago said on Saturday.The country, which has 52,000 inhabitants and is part of the Kingdom of Denmark, hasn’t registered any deaths from the virus. Denmark’s toll stands at 522 fatalities from more than 10,400 cases.Belgian Daily Tests Exceed 25,000 (5:26 p.m. HK)Belgium reported 585 new coronavirus infections in the past 24 hours, down from 591 the prior day. The country carried out 25,410 tests, the most for a single day since the start of the outbreak and in line with its stated daily capacity of 25,000.Additional fatalities of 76 compare with 107 the prior day. The seven-day average of reported deaths, the measurement favored by Belgian virologists, declined by 4% to 5% a day in the past week. The total death toll in the country of 11.4 million now stands at 8,581.Seoul Nightclubs Linked to Spike (4:19 p.m. HK)A potential second wave of infections could be possible in South Korea after confirmed cases suddenly increased following a lull, with a surge tied to nightclubs in Seoul.The total number of cases linked to nightclubs in the Itaewon neighborhood visited by a 29-year-old patient earlier this month increased to 40 as of noon Saturday, the city’s Mayor Park Won-soon said in a briefing. Park ordered the closing of all nightclubs, discos, hostess bars and other similar nightlife establishments in the capital.Virus Cases Decline Across Several Parts of Asia (3:30 p.m. HK)Virus cases declined in several Asian economies on Saturday, with Hong Kong and Taiwan reporting zero. Countries including China and Thailand reported fewer than 10 new infections, with Australia adding 16.Singapore, one of the last countries in the region to close schools and implement strict containment measures, confirmed 753 new cases on Saturday, down from 768 tallied by Johns Hopkins University Friday. The vast majority are migrant workers living in crowded dormitories.For more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source.©2020 Bloomberg L.P.





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Animal Legal Def. Fund v. FDA

(United States Ninth Circuit) - In a Freedom of Information Act (FOIA) case, challenging the FDA's decision to redact certain commercially-sensitive information concerning egg-production farms in Texas, the district court's grant of summary judgment to defendant is affirmed where the FDA properly withheld information under FOIA exemption 4 that was likely to cause substantial competitive harm.




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FDA approves ventilator designed by particle physics community

Led by Princeton’s Cristian Galbiati, a massive international team worked to design, test and finalize the Mechanical Ventilator Milano (MVM), a low-cost ventilator designed to ease device shortages caused by COVID-19.




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Donald Kennedy, former Stanford president and FDA chief, dies of COVID-19

The former Stanford University president emphasized undergraduate teaching, led a $1-billion capital campaign and earned a reputation as "the students' president."




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velocityconf: Call for speakers and registration is open for @webperfdays in Silicon Valley http://t.co/cJKBmynkjI June 22, Google HQ (cc @sfwebperf)

velocityconf: Call for speakers and registration is open for @webperfdays in Silicon Valley http://t.co/cJKBmynkjI June 22, Google HQ (cc @sfwebperf)