Tag - fda

 
 

FDA

Japan Times
BUSINESS
Jun 1, 2023
Contaminated drugs, shredded papers: U.S. FDA uncovers failures in India pharma factories
Authorities have suspended the licenses of more than a dozen unlisted drugmakers in the wake of dozens of cough syrup deaths.
Japan Times
COMMENTARY / World
Apr 19, 2023
Abortion pill rulings to impact pharmaceutical innovation
Bringing new drugs to market is already expensive and time-consuming. Undercutting the FDA will only make it harder.
Japan Times
COMMENTARY / World
Sep 29, 2021
Liars may get COVID-19 boosters before those in need
Who will get the booster shots? Sadly, the answer is too many of the wrong people and too few of the right ones, adding more messiness to the rollout process.
Japan Times
WORLD
Aug 21, 2021
Pfizer COVID-19 vaccine poised to get full U.S. approval next week
President Joe Biden believes the approval will help woo more Americans to get the shot. Pfizer's vaccine has been in use in the U.S. based on an emergency authorization.
Japan Times
COMMENTARY / World
Jul 19, 2021
Latest U.S. Alzheimer's drug fix is a patch job
Most of the FDA's decisions don't receive national attention, which means they may not be rectified until substantial harm is done.
Japan Times
COMMENTARY / World
Apr 14, 2021
The FDA’s caution on the J&J vaccine is a costly mistake
The FDA acted after blood clots were observed in less than one in a million people who have received the J&J vaccine. COVID-19 has already killed 1,712 out of every million Americans.
Japan Times
BUSINESS
Feb 6, 2020
Juul bulks up science staff as FDA vaping deadline looms
Juul Labs Inc. has hired former Food and Drug Administration employees and is recruiting more researchers as it prepares for a crucial regulatory hurdle that will determine the future of the top U.S. e-cigarette maker.
Japan Times
BUSINESS
Dec 6, 2019
Biogen builds case for its Alzheimer's drug, but skeptics say more data needed
Biogen Inc. laid out more data Thursday on its experimental Alzheimer's drug, raising no major safety alarms but also offering little compelling evidence that the drug, once declared a failure, actually works.
Japan Times
WORLD / Science & Health
Oct 25, 2019
FDA investigating heartburn drug Zantac for carcinogen risks
The U.S. Food and Drug Administration is investigating whether the popular heartburn drug Zantac causes carcinogens to form in the bodies of users, in an effort to fully understand the risks posed by the already recalled drug, the agency's spokesman said on Thursday.
Japan Times
BUSINESS
Oct 23, 2019
Biogen and Eisai revive plans for Alzheimer's drug aducanumab, but prospects still shaky
Biogen Inc. revived plans on Tuesday to seek U.S. approval for the Alzheimer's treatment aducanumab and said data from more patients in two discontinued studies showed the drug reduced the decline of patients.
Japan Times
WORLD / Science & Health
Oct 18, 2019
Over half of Wisconsin vaping samples tested by FDA contain marijuana ingredient THC
Vaping product samples from Wisconsin linked to a rash of serious lung injuries tested by U.S. health regulators showed that more than half contained THC, the psychoactive ingredient in marijuana, according to a summary of a preliminary report seen by Reuters.
Japan Times
WORLD / Science & Health
Oct 9, 2019
GSK recalls popular heartburn drug Zantac globally amid cancer scare
GlaxoSmithKline on Tuesday said it is recalling the popular heartburn medicine Zantac in all markets as a "precaution," days after the U.S. Food and Drug Administration found "unacceptable" levels of probable cancer-causing impurity in the drug.
ASIA PACIFIC / Science & Health
Sep 30, 2019
Bangladesh bans heartburn drug ranitidine over cancer fears after U.S. FDA issues warning
Bangladesh's drug regulatory authority on Sunday issued a ban on sales of popular heartburn drug ranitidine while it investigates a potential cancer-causing substance in the drug.
Japan Times
WORLD / Science & Health
Sep 11, 2019
'It is time to stop vaping': Kansas reports sixth U.S. death linked to mystery illness involving e-cigarettes
A Kansas resident was the sixth person to die in the United States of a mysterious respiratory illness related to vaping, state officials said on Tuesday, as public health officials scrambled to understand a nationwide health problem.
Japan Times
BUSINESS
Aug 8, 2019
Novartis says it knew of Zolgensma data problems before U.S. approval
Swiss Drugmaker Novartis AG on Wednesday said it knew about discrepancies in data it submitted to regulators as it sought approval of its more than $2 million gene therapy Zolgensma, but delayed notifying authorities until it completed an internal investigation.
Japan Times
WORLD / Science & Health
May 7, 2019
High levels of sunscreen ingredients end up in bloodstream, FDA researchers say
The active ingredients of commonly used sunscreens end up in the bloodstream at much higher levels than current U.S. guidelines from health regulators and warrant further safety studies, according to a small study conducted by U.S. Food and Drug Administration researchers and published on Monday.
BUSINESS
Jul 18, 2018
China heart drug sold globally may have had cancer-linked impurity since 2012
A common blood pressure and heart drug manufactured in bulk by a Chinese company and sold worldwide may have contained an impurity linked to cancer since 2012, European regulators said on Tuesday.
Japan Times
WORLD / Science & Health
Oct 26, 2017
FDA hopes to lift stigma on using drugs as treatment for opioid addiction in face of resistance
As the opioid epidemic in the U.S. continues to kill more and more Americans, the Food and Drug Administration wants to lift the stigma on the idea of using drugs to treat a drug habit.
WORLD / Politics
Dec 13, 2016
Trump eying venture capitalist Dr. Scott Gottlieb as FDA head
Dr. Scott Gottlieb, a partner at one of the world's largest venture capital funds and a former deputy commissioner at the U.S. Food and Drug Administration, is being considered by President-elect Donald Trump to run the agency, according to sources close to the transition team.

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Construction takes place on the Takanawa Gateway Convention Center in Tokyo, slated to open in 2025.
A boom for business tourism in Japan?