STAT+: Despite fanfare, the FDA’s step toward lowering nicotine levels in cigarettes is a very early one
WASHINGTON — When the Food and Drug Administration said Tuesday it would eventually lower the…
Category: government agencies
Biden picks former DARPA director Prabhakar as next science adviser
WASHINGTON — President Biden will soon nominate Arati Prabhakar, a physicist and former DARPA director,…
STAT+: Senate lawmakers introduce a bill to help the FDA and the U.S. Patent Office coordinate
Amid concerns that patent reviewers disregard competitive effects on prescription drugs, a bipartisan group of…
Opinion: The U.S. needs to revitalize research on the health effects of low-dose radiation
People are exposed to low-dose radiation in many ways: having a CT scan, working as…
STAT+: HCA, Steward abandon hospital deal in another win for FTC
For-profit hospital chains HCA Healthcare and Steward Health Care have terminated their proposed hospital sales,…
Opinion: New report: gains in patient safety have stalled over the past decade
Hospital care helps patients recover from serious illness and injury but, all too often, patients…
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STAT+: FDA oversight of pharma manufacturing facilities plunges during the pandemic
Each year, the Food and Drug Administration tracks its progress inspecting pharmaceutical manufacturing facilities and…
STAT+: Pharmalittle: Lawmakers urge FTC to probe blood thinner prices; EU pressures Covid vaccine makers to renegotiate contracts
Top of the morning to you. Gray skies are hovering over the Pharmalot campus right…
STAT+: The FTC says it’s getting tougher on hospital consolidation. Antitrust experts aren’t buying it
After the Federal Trade Commission’s flashy announcements last week that it was suing to block…
STAT+: FDA approved more cancer drugs than EMA, but they may not have always benefited patients
Amid rising pressure to endorse new medicines, U.S. regulators greatly outpaced their European counterpart in…
Opinion: Lessons from earlier pandemics: Vaccine panel must discuss imprinting among infants and toddlers
This week, when the CDC’s vaccine advisory committee considers approving the Moderna and Pfizer/BioNTech mRNA…
STAT+: Pharmalittle: Canada OKs ALS drug still waiting FDA approval; WTO talks on Covid patent waiver are down to the wire
Good morning, everyone, and welcome to another working week. We hope the weekend respite was…
STAT+: Pharmalittle: FDA panel endorses Bluebird Bio gene therapy for rare disease; GSK touts RSV vaccine trial results
And so, another working week will soon draw to a close. Not a moment too…
FDA advisers unanimously endorse Bluebird’s gene therapy for rare disorder
Advisers to the Food and Drug Administration voted unanimously in favor of approving an investigational…
How much medicine does the U.S. actually have to fight monkeypox?
WASHINGTON — As the world grapples with a monkeypox outbreak, the Biden administration has been quick…
‘Testing bottleneck’ for monkeypox puts hope of containment at risk, experts warn
Infectious disease specialists are growing increasingly concerned by the U.S. strategy for testing for monkeypox,…
STAT+: Francis Collins: Concern about independence of new moonshot science agency ARPA-H are ‘overblown’
WASHINGTON — Francis Collins thinks the debate surrounding the Biden administration’s new high-stakes research agency…
How the Covid-19 pandemic prepared the White House to respond to monkeypox
WASHINGTON — The man at the center of the White House’s biodefense strategy is only…
STAT+: Documents show problems at Novartis facility where cancer drug production was halted
Earlier this month, Novartis took the surprising step of voluntarily suspending production of two therapies…
Biden administration won’t lower seniors’ Medicare premiums this year, despite changes to coverage of new Alzheimer’s drug
WASHINGTON — The Biden administration on Friday said it will not lower Medicare premiums for…
STAT+: Key Senate committee proposes a council to ensure FDA better coordinates on accelerated approvals
WASHINGTON — The Senate is taking pains to avoid another Aduhelm controversy. In new bipartisan…
STAT+: The FDA says it’s in the dark about thousands of dietary supplement ingredients
WASHINGTON — The companies that make dietary supplements like vitamins and herbs have quietly introduced…
STAT+: European regulator suspends generic drugs after finding flawed studies
In the latest dust-up over the safety of medicines, the European Medicines Agency recommended suspending…
STAT+: Senate FDA legislation will include dietary supplement, cosmetic reforms
WASHINGTON – Senate lawmakers are set to unveil draft legislation as soon as Monday that…
STAT+: National Institutes of Health licenses nearly a dozen Covid-19 technologies to a WHO program
In a notable bid to widen global access to Covid-19 medical products, the National Institutes…
STAT+: The FDA eased rules for mental health apps during the pandemic. Now companies are bracing for it to tighten the reins
In April 2020, as the horrors of the pandemic were beginning to unspool, the Food…
STAT+: The panel was supposed to improve efficiency at the NIH. It hasn’t even met for 7 years
WASHINGTON — An oversight board tasked with making the National Institutes of Health more efficient…
Opinion: Flawed FDA safety requirements are hamstringing a highly effective treatment for severe schizophrenia
For medications with serious safety concerns the Food and Drug Administration mandates a Risk Evaluation…
STAT+: FDA warns Miami University contract testing lab over falsified data, poor quality control
A contract testing laboratory run by Miami University was scolded by the U.S. Food and…
STAT+: Is the FDA taking advice from its expert panels? A new analysis points to inconsistencies in the process
For decades, the U.S. Food and Drug Administration has relied on outside expert panels for…
STAT+: U.S. Trade Rep report sparks concern that a new clash may occur over clinical trial transparency
A recent Biden administration report on “significant” foreign barriers to U.S. exports suggests that a…
STAT+: Pharmalittle: Investors reject proposals for Covid vaccine makers to share know-how; CMS head says Alzheimer’s drug decision is rare
And so, another working week will soon draw to a close. Not a moment too…
Opinion: HHS needs to step up so CDC’s new guidelines won’t be ‘a bridge to nowhere’ for most Americans living with chronic pain
To update its controversial 2016 guidelines for how to treat the millions of Americans living…
FDA issues plan to ban menthol in cigarettes, cigars
WASHINGTON — The U.S. government on Thursday released its long-awaited plan to ban menthol cigarettes…
STAT+: Tough questions, few answers: The FDA wrestles with its approach to AI in medicine
It was a brave thing for the Food and Drug Administration to do. Earlier this…
STAT+: One in four pharma status reports on follow-up trials are late or aren’t filed
Drug companies failed to submit 11% of status reports for clinical trials they were required…
Opinion: Access to kidney transplantation is improving for everyone, but more work remains to be done
Organ donation and transplantation are saving more lives in the United States than ever before,…
Listen: An ominous biotech deal, vaccines for kids, & ‘breakthrough’ devices
Can buyouts be bad news? Why can’t Novavax meet a deadline? And what does “breakthrough”…
STAT+: What counts as a breakthrough? 8 insights on the FDA’s approach to medical devices
The word breakthrough carries a kind of weight: It’s a dramatic step forward, a critical…
Investigating FDA’s breakthrough devices, big data ethics, & AI for colon cancer
You’re reading the web edition of STAT Health Tech, our guide to how tech is…
STAT+: Animal rights group urges USDA to probe research facilities for failing to inspect monkey shipments
A prominent animal rights group asked U.S. authorities to investigate leading medical research labs for…
As FDA offers breakthrough designation to device makers, patients and providers are left with questions
Since launching in 2017, an ambitious and secretive Food and Drug Administration program to speed…
STAT+: Breakthrough Device Tracker: An authoritative database of FDA’s fast-tracked medical devices
The world of medical devices is growing more sprawling every day. Some promising novel ideas…
STAT+: FDA’s breakthrough device program, meant to benefit patients, is delivering the biggest gains for companies
Five years ago, the Food and Drug Administration launched a new program with the best…
Opinion: FDA needs to follow through on its plan to ban carbadox in animal feed
An antibiotic known as carbadox can damage genes and cause cancer. The European Union, Canada,…
Opinion: India’s drug regulator has ignored red alerts on Covaxin, imperiling millions of lives
In a shocking turn of events, the World Health Organization warned United Nations agencies against…
STAT+: Justice Department probes Bausch Health over marketing for dermatology drugs
Bausch Health is being investigated by U.S. authorities in connection with marketing of four medicines…
STAT+: Pharma pledges faster drug launches in Europe in hopes of avoiding stricter regulations
In a bid to thwart stricter regulation, the European pharmaceutical industry trade group pledged to…
STAT+: FDA scolds Bausch Health for misleading claims about a psoriasis cream
The U.S. Food and Drug Administration has scolded Bausch Health for a video and webpage…
Medicare finalizes its restrictions on new Alzheimer’s drug, despite pressure from drugmakers
WASHINGTON — Medicare on Thursday finalized its plan to restrict coverage for the controversial, pricey…