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GoodRx leaked sensitive health information to Facebook and Google, FTC alleges
The Federal Trade Commission on Wednesday accused GoodRx, the prescription drug discount platform, of sharing…
Category: government agencies
STAT+: Pharma wins a key round in a court battle with hospitals over a drug discount program
In a victory for the pharmaceutical industry, a federal appeals court ruled drug companies have…
STAT+: FDA names former Oracle executive as new digital health leader
The Food and Drug Administration has installed Troy Tazbaz, most recently a senior vice president…
STAT+: Novartis and Lilly turn to nonprofit, instead of FDA, to resolve dispute over drug ad
In a rare move, the Better Business Bureau National Programs settled a dispute between two…
STAT+: Doctors’ group complains that 60 Minutes segment on Wegovy was really just an ad
A physicians’ group has filed a complaint with the U.S. Food and Drug Administration alleging…
STAT+: Despite court ruling, FDA will continue with its approach to approving orphan drug exclusivity
In an unexpected move, the U.S. Food and Drug Administration will continue to apply exclusive…
STAT+: FTC wants ‘pharma bro’ Martin Shkreli held in contempt for violating lifelong ban on working in pharma
The U.S. Federal Trade Commission asked a federal judge to hold “pharma bro” Martin Shkreli…
STAT+: ‘A cascade of failures’: FDA cites Indian drugmaker for numerous quality control problems
In a stunning rebuke, the U.S. Food and Drug Administration accused a drugmaker of a…
STAT+: Pallone pushes NIH and FDA to disclose steps being taken to ensure clinical trial results are reported
A Democratic lawmaker is demanding to know what steps the U.S. Food and Drug Administration…
STAT+: Lawmakers again urge the Biden administration to use federal law to widen access to a cancer drug
For the third time in less than a year, a group of lawmakers is urging…
STAT+: FDA scolds Sun Pharmaceutical for serious quality control problems at a key plant in India
Sun Pharmaceutical, one of the world’s largest generic drugmakers, was scolded by the U.S. Food…
An FDA pathway to clear medical devices is putting patients at risk, research suggests
The Food and Drug Administration’s approach to evaluating some new medical devices might actually increase…
STAT+: The FDA has approved a new Alzheimer’s drug, but wide access may depend on CMS easing restrictions
Now that the U.S. Food and Drug Administration has granted accelerated approval to the widely…
STAT+: Audit of FDA’s tobacco oversight underscores agency’s struggle to regulate the booming vaping market
WASHINGTON – The Food and Drug Administration’s Center for Tobacco Products is lacking clear goals…
Biden administration unveils dashboard to track nonfatal drug overdoses
The Biden administration is rolling out a new tool meant to help prevent drug deaths:…
STAT+: FDA scolds company that raised red flags over impurities in many widely used medicines
Two years after an independent laboratory began pushing the U.S. Food and Drug Administration to…
Top U.S. addiction researcher calls for broad deregulation of methadone
BOSTON — The U.S. government’s top addiction researcher is calling for broad deregulation of methadone,…
‘I pushed back’: Fauci on how his response to Trump on Covid turned him into ‘public enemy No. 1’
As he faces the possibility of increased scrutiny from what is likely to be a…
New CDC opioid guidelines emphasize flexibility in treating pain
Federal health officials on Thursday updated their recommendations for using opioids to treat pain, removing…
FDA, DOJ sue 6 vape shops for ignoring warnings about selling illegal products
WASHINGTON — The Biden administration is suing six vape shops after the companies ignored Food…
Biden officials scramble for a backup as Covid variants threaten a key therapy for immunocompromised people
WASHINGTON — Biden health officials are bracing for the prospect that the country’s sole preventive…
STAT+: Bright exits ACA health insurance marketplaces to stay afloat
Bright Health Group is drastically cutting back its health insurance offerings for next year, including…
A minuscule new HHS office has a mammoth goal: tackling environmental justice
WASHINGTON — Ask 10 people how a federal health care agency might tackle “environmental justice,”…
STAT+: European Commission says preliminary findings indicate Teva violated antitrust rules
After three years of probing, the European Commission has reached a preliminary decision that Teva…
STAT+: Health plans say texting could help reach underserved patients. But a federal rule is getting in their way
Health plans trying to reach low-income and underserved customers say they’re being stymied by a…
In new guidance, FDA says AI tools to warn of sepsis should be regulated as devices
The U.S. Food and Drug Administration on Tuesday published a list of artificial intelligence tools…
White House directs agencies to make federally funded studies free to access
The White House on Thursday directed health and science agencies to make federally funded studies…
STAT+: Major Indian generic drugmaker closes a U.S. facility after years of manufacturing problems
After a decade of manufacturing problems, a U.S. federal court ordered a unit of Wockhardt,…
Anthony Fauci to step down as nation’s top infectious disease official
Anthony Fauci, the top U.S. infectious diseases official for decades and a leading researcher on…
Over-the-counter hearing aids expected this fall in U.S.
Millions of Americans will be able to buy hearing aids without a prescription later this…
STAT+: The FDA’s ‘breakthrough’ medical devices are finally hitting the market in numbers
The Breakthrough Device Program is approaching terminal velocity. The Food and Drug Administration, looking to…
Cities are lobbying to host the ARPA-H headquarters. Experts don’t understand why
WASHINGTON — America’s mayors are drooling over President Biden’s new high-stakes research agency, ARPA-H. They…
Opinion: WTO: Don’t make a bad situation worse by granting intellectual property waivers for Covid-19 therapeutics and diagnostics
The World Trade Organization recently agreed to suspend patent protections for Covid-19 vaccines. The trade…
STAT+: FDA’s decision to review a Biogen ALS drug is met with skepticism and uncertainty on Wall Street
Once again, the U.S. Food and Drug Administration made a surprise move regarding an experimental…
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Opinion: The FDA needs to get ready to evaluate synthetic cells, the next generation of therapeutics
Expanding new medical treatments requires pushing — and sometimes breaking — the boundaries of what…
STAT+: ‘No magic bullet’: For drugmakers and the FDA, clinical trials on ultra-rare diseases pose thorny challenges
Walker Burger is beside himself with worry. The 33-year-old relies on an experimental medicine to…
STAT+: Pfizer loses another court battle alleging the U.S. illegally limits use of copay assistance programs
In another setback for the pharmaceutical industry, a federal appeals court panel upheld a ruling…
STAT+: Federal patent initiatives could cause ‘headwinds’ for drugmakers and their broad filings
For the second time this month, the U.S. Patent & Trademark Office has taken a…
Opinion: STAT+: For safety’s sake, it’s time to get medical device identifiers over the finish line
This week, an under-the-radar U.S. government advisory group called the National Committee on Vital and…
STAT+: ‘Eye-opening’: The pandemic accelerated antimicrobial resistance across the U.S.
Resistance to medicines for combating superbugs has considerably worsened during the pandemic, with deaths and…
Opinion: FDA rule would facilitate prescription-to-OTC switches but nix a third class of drugs
After a decade-long wait, the Food and Drug Administration finally issued a proposed rule in…
Drugmaker seeks FDA approval of over-the-counter birth control pill
WASHINGTON — For the first time, a pharmaceutical company has asked for permission to sell…
FDA appears to hold off on crackdown on synthetic nicotine products, despite calls from Congress
WASHINGTON — Congress gave the Food and Drug Administration a clear directive to crack down…
STAT+: In the search for an ARPA-H director, the White House is zeroing in on DARPA veterans
WASHINGTON — The White House is zeroing in on former DARPA officials as candidates to…
Opinion: The FDA owes parents an explanation about why it delayed authorizing Moderna’s Covid-19 vaccine for young kids
Until mid-June, 1 in 13 persons living in the United States — that’s all children…
Opinion: The monkeypox vaccine underscores the value of U.S. investments in preparedness
After living through the Covid-19 epidemic, many people around the world reacted to the sudden…
Opinion: Improve CDC’s quarantine stations to prevent the next pandemic
In today’s interconnected world, people, packages, and animals can circumnavigate the globe in less than…
Opinion: FDA: Don’t rush a move to change the Covid-19 vaccine composition
On Tuesday, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 19-2 to…
The Biden administration wants to get tough on states’ abortion pill restrictions. It won’t be easy
WASHINGTON — Attorney General Merrick Garland is hinting he’s ready to get tough on states…
Listen: Juul’s doomsday, Merck’s buyout plans, & the next Theranos verdict
Just how powerful is the FDA? Is Merck about to spend $40 billion? And what’s…