Opinion: NIH: It’s time to make your mark on the renaissance of medicinal psychedelics
Just a few years ago, investments in medicinal psychedelic research were rare in even the…
Category: government agencies
STAT+: FTC issues a non-committal report on ‘rebate walls,’ but will the agency dig deeper?
In response to Congressional concerns over prescription drug pricing, the Federal Trade Commission released a…
Grilling Scott Gottlieb on burgers, drugs, and a post-pandemic summer
Memorial Day weekend is around the corner, which means summer is finally here. Ahead of…
STAT+: FDA revives a controversial program the Trump administration ended over ‘inaccuracies’
In an unexpected move, the Food and Drug Administration is reversing a decision by the…
Opinion: Created correctly, the Advanced Research Projects Agency for Health will accelerate medical innovation
The U.S. needs a bold initiative to achieve transformative progress in the fight against Alzheimer’s…
Opinion: The CDC’s latest blunder is about trust, not masks
The announcement by the Centers for Disease Control and Prevention (CDC) that fully vaccinated people…
STAT+: Drug makers argue an HHS rule would penalize them for offering co-pay coupons
After months of controversy, the pharmaceutical industry’s biggest trade group has filed a lawsuit accusing…
STAT+: Health tech companies form a new coalition to advance the role of real-world data
On Wednesday, five health data analytics companies announced they have banded together to form an…
STAT+: Democrats call on FTC to investigate AbbVie’s Humira pricing strategy
WASHINGTON — Three powerful Democrats wrote to the Federal Trade Commission Tuesday urging them to…
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STAT+: Feds tell drug makers to offer discounts to safety-net hospitals or face penalties
After a year of controversy, the Health Resources and Services Administration notified six large drug…
Listen: Lessons from a botched pandemic response, CDC sluggishness, & the future of health tech
Can we prevent the next Covid-19? Has the CDC become too cautious? And how many…
CDC’s slow, cautious messaging on Covid-19 seems out of step with the moment, public health experts say
WASHINGTON — Nearly a year ago, amid concerns about how to prevent transmission of the…
Opinion: STAT+: Faster approval of complex generics is central to affordable, equitable care
The push to improve Americans’ use of effective and less-expensive generic medications is getting a…
STAT+: Biogen’s Alzheimer’s drug may only be cost effective at $2,500 a year
The controversial, but widely anticipated Biogen (BIIB) treatment for Alzheimer’s would only be cost-effective if…
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STAT+: Biden’s Medicaid pressure tactics could put his team at odds with hospitals
WASHINGTON — The Biden administration is pressuring states to expand Medicaid — and it’s setting…
Opinion: ALS groups to the FDA and drug sponsors: ‘We won’t be played again’
Working to improve the fight for therapies for amyotrophic lateral sclerosis (ALS, also known as…
FDA says it will ban all menthol cigarettes and flavored cigars
WASHINGTON — The Food and Drug Administration announced Thursday that it will ban all menthol…
STAT+: For the first time, the FDA may fine a drug maker for failing to post clinical trial results
The Food and Drug Administration is threatening to fine Acceleron Pharma (XLRN) for failing to…
STAT+: The FDA will this week decide whether to ban menthol cigarettes — but most likely, the fight is just getting started
WASHINGTON — The Food and Drug Administration will decide this week whether to ban menthol…
Opinion: Congress: stand up to the paper lobby and abolish outdated paper labeling for clinicians
There’s no place in health care for practices that fail to serve the best interests…
Listen: The latest mask debate, FDA in limbo, & gene therapy’s uncertain upside
When can we stop wearing masks outside? Are we ever getting a permanent FDA commissioner?…
A new crop of medical devices are trying to hack the vagus nerve to treat disease
The vagus nerve, also known as the “wandering nerve,” winds a path all around your…
STAT+: FDA issues scathing report of Emergent plant responsible for contaminated Covid-19 vaccines
The Food and Drug Administration issued a scathing inspection report of the Emergent BioSolutions (EBS)…
Opinion: FDA: make medical apps reliable, not risky
The fear of Covid-19 catapulted symptom checkers from the periphery of public attention to the…
Top Senate Republican holds up Biden’s CMS nominee over Texas Medicaid waiver
WASHINGTON — A top Senate Republican is holding up the confirmation of President Biden’s nominee…
Opinion: FTC’s challenge to Illumina’s vertical merger with Grail is all wrong
My mom died of stage 4 cancer in February 2008. Had the technology existed then…
STAT+: Biden officials met privately with 3M, AmerisourceBergen, PhRMA and more to debate shoring up the national stockpile
WASHINGTON — The Biden administration met privately this month with some of the nation’s biggest…
Opinion: STAT+: The FDA should embrace remote and automated drug inspection technology
While pharmaceutical regulatory authorities in other countries are employing creative ways like video-based remote inspections…
STAT+: In a sharp rebuke, health officials toss Trump-era proposal to exempt medical AI tools from review
In a searing rebuke, the Biden administration is formally withdrawing a last-minute proposal by the…
FDA wants more data on promising ALS drug, frustrating patients seeking faster access
People living with amyotrophic lateral sclerosis, or ALS, in the U.S. will have to wait…
STAT+: FDA is urged to move faster to list medicines withdrawn over safety concerns
Arguing patient safety is at risk, an advocacy group is urging the Food and Drug…
STAT+: PhRMA chief talks strategy — and he’s surprisingly optimistic about drug pricing reform
WASHINGTON — Steve Ubl, who leads the drug industry lobbying powerhouse PhRMA, has a bold…
STAT+: Cavazzoni to take over influential spot atop FDA drug center
WASHINGTON — Patrizia Cavazzoni has been named the permanent leader of the FDA’s Center for…
Biden officials rebuff appeals to surge Covid-19 vaccine to Michigan amid growing crisis
WASHINGTON — Amid Michigan’s worst-in-the-nation coronavirus surge, scientists and public health officials are urging the…
STAT+: FDA is rebuked by a federal agency for downgrading serious concerns over plant inspections
In a stern letter, the U.S. Office of Special Counsel rebuked the Food and Drug…
STAT+: Former Medicare leader Seema Verma joins board of health tech firm Lumeris
She was President Trump’s top Medicare official. Now, Seema Verma, the former Centers for Medicare…
STAT+: The U.S. government doesn’t have patent rights to Gilead’s remdesivir, despite investing millions in research
American taxpayers may have provided $162 million toward researching the drug remdesivir, but the federal…
STAT+: FTC seeks to block Illumina from buying Grail, citing threats to competition
The Federal Trade Commission is once again trying to block Illumina, a dominant maker of…
STAT+: Here are the drug pricing policy options Democrats could use to pay for their next big legislative push
WASHINGTON — Democrats in Congress are already gearing up for their next big legislative push,…
STAT+: The operation formerly known as Warp Speed: Biden leans heavily on the flagship Trump-era initiative
WASHINGTON — The Biden White House has made no secret of its disdain for President…
‘Right now I’m scared’: CDC director warns of a coming spike in Covid-19 case counts
WASHINGTON — As Covid-19 cases begin again to spike throughout the United States, CDC Director…
STAT+: EPA rule that could help citrus growers is challenged over concerns about antibiotic resistance
Amid rising concern over antibiotic resistance, a coalition of advocacy groups has filed a lawsuit…
STAT+: Pfizer hopes for a happy ending for an osteoarthritis drug with a troubled history
For more than a decade, Pfizer has run dozens of trials in hopes of eventually…
The saga of mishaps and miscommunications overshadowing AstraZeneca’s Covid vaccine
Yet again, AstraZeneca is in a crisis of its own making. The latest in the…
STAT+: Amy Abernethy, deputy commissioner who aimed to amp up FDA’s tech knowhow, to leave post
Amy Abernethy, the number two official at the Food and Drug Administration, plans to depart…
STAT+: Pharmalittle: AstraZeneca may have used ‘outdated’ info about its Covid-19 shot; Democrats eye drug-pricing measures
Rise and shine, everyone, another busy day is on the way. We can tell by…
STAT+: Digital therapeutics startups are ready for more regulation, not less
Digital therapeutics companies are eager to show their work. Five days before President Biden took…
STAT+: Does a drug’s name affect how patients and doctors perceive it? The FDA wants to know
Drug makers may spend untold sums of money giving medicines zippy names. Now, regulators want…
Backed by Amazon Care and Intermountain, a new coalition lobbies for policy changes around at-home care
The telehealth boom has made one thing clear: The era of health care provided exclusively…
STAT+: Pharma wins a round in a battle with HHS over a drug discount program for hospitals
In a victory for the pharmaceutical industry, a federal judge temporarily blocked the federal government…