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STAT+: Key takeaways from AdvaMed, the world’s largest medical device conference
ANAHEIM, Calif. — Thousands of workers in the medical device industry gathered here this week…
Category: FDA
With Ozempic, Wall Street moves on from a whole other class of medicines
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Opinion: STAT+: How payer-participating trials could help transform clinical research on FDA-approved drugs
Earlier this year, Food and Drug Administration Commissioner Robert M. Califf proposed something radical: that…
STAT+: To prevent amputation in patients with severe vascular disease, a device turns veins into arteries
An innocuous slip while cutting her toenails created a wound on Cynthia Elford’s right foot…
STAT+: FDA cites Fresenius Kabi for contamination problems that CDC linked to deadly sepsis cases
Several cases of sepsis — three of which ended in patients deaths — were traced…
FDA calls for treatments for meth and cocaine addiction
No medication is approved to treat addiction to either methamphetamine or cocaine. But the Food…
The major biotech news updates you need to read today
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STAT+: Former FDA official lays out how to keep patients safe from risky medical devices
Madris Kinard’s unlikely journey to becoming a champion for patient safety started in a fire…
STAT+: What we owe ALS patients — and why one company fell short
What do you say to a patient when the FDA rejects “their” experimental drug —…
STAT+: FDA seeks to regulate lab-developed tests, closing the ‘Theranos loophole’
The Food and Drug Administration on Friday announced its intention to start regulating tests developed…
Listen: Who discovered GLP-1? Plus: BrainStorm at the FDA and biotech’s slump
When is negative data positive enough? Who gets credit for scientific breakthroughs? And wasn’t biotech…
STAT+: FDA advisers vote overwhelmingly against ALS treatment from BrainStorm
A panel of independent advisers to the Food and Drug Administration voted overwhelmingly against a…
STAT+: Over-the-counter Sudafed doesn’t work. Neither does our system for evaluating older drugs
You would have been forgiven for being surprised on Sept. 12 when a panel of…
Opinion: STAT+: The problem with potential changes to the biosimilar regulatory framework
Biosimilars are no longer a new and untested class of medicines. Today, they provide critical…
STAT+: BrainStorm’s case for ALS approval relies on ‘grossly deficient’ data, FDA finds
The Food and Drug Administration said Monday that it has deep reservations about NurOwn, an…
Markey and Manchin urge FDA to stop its study of opioids for chronic pain
Two Democratic senators are warning the Food and Drug Administration not to proceed with a…
STAT+: FDA panel votes against GLP-1 therapy from former diabetes unicorn Intarcia
An advisory panel to the Food and Drug Administration unanimously voted against a diabetes implant…
A thorny ALS debate at the FDA, and the promise of artificial wombs
Can the FDA be too flexible? How do you test a mechanical womb? And who…
STAT+: Travere kidney drug narrowly fails confirmatory trial following FDA approval
Travere Therapeutics said Thursday that a study meant to confirm the benefit of its newly…
STAT+: What to know about the polarizing ALS drug headed for FDA scrutiny next week
Years of polarizing scientific discourse and bruising online debate will come to a head next…
STAT+: Approval setback for EpiPen alternative puts spotlight on common anti-competition tactic
Americans who suffer severe allergic reactions won’t have alternatives to autoinjectors like the Epipen for…
STAT+: FDA weighs animal data, ethical dilemmas at panel on artificial wombs
The Food and Drug Administration’s advisory panel of pediatric experts met on Tuesday to discuss…
STAT+: What happened to the House vote on health care price transparency?
You’re reading the web edition of D.C. Diagnosis. Sign up here to receive this newsletter in your…
STAT+: Artificial wombs, after years in development, reach FDA review for human trials
The artificial womb, a device aiming to save infants born way too soon, is inching…
Listen: Covid’s latest surge, Alnylam at the FDA, & the end of an era
What does Covid-19 have in store for the winter? When are good data not good…
STAT+: Lawmakers introduce bill to require drugmakers to provide key info to both FDA and U.S. Patent Office
Amid concerns over monopolies held by drugmakers, a bipartisan group of lawmakers introduced a bill…
Popular nasal decongestant doesn’t actually relieve congestion, FDA experts say
WASHINGTON — The leading decongestant used by millions of Americans looking for relief from a…
Is there a path forward for PEPFAR?
You’re reading the web edition of D.C. Diagnosis. Sign up here to receive this newsletter in your…
Opinion: Patients might finally receive practical information with prescriptions — if the FDA doesn’t blow it
Patients often ask two questions about every medical treatment: Will it help me? Will it…
STAT+: FDA proposes changes to key approval pathway for medical devices, five years after promising
Five years after promising to fix a flawed regulatory pathway widely used by medical device…
FDA approves updated Covid-19 vaccines
The Food and Drug Administration announced Monday that it had greenlit two updated Covid-19 booster shots…
ALS advocates say criticism of new drugs misses bigger picture
A diagnosis of ALS has long been seen as a death sentence. But in recent…
STAT+: House committees strike deal on health transparency, PBM reform package
WASHINGTON — Republicans on three key House committees have reconciled their differing legislative packages to…
STAT+: FDA delays enforcement of a pharmaceutical supply chain law to stop counterfeit drugs
In response to growing complaints, the U.S. Food and Drug Administration has postponed its plans…
STAT+: Pharmalittle: This fall’s COVID booster rollout; approval for Pfizer’s RSV vaccine
Good morning Pharmalittle students. This is Allison DeAngelis, filling in for Ed Silverman while he’s…
U.S. health officials lay out plans to cope with respiratory virus season
With last fall’s chaotic early start to the respiratory virus season still fresh in the…
Abortion policy in the spotlight, DeSantis’ importation showdown, and new price hike analysis
You’re reading the web edition of D.C. Diagnosis. Sign up here to receive this newsletter…
STAT+: FDA panel votes against high blood pressure device from Medtronic, but lends support to ReCor Medical’s
An advisory panel to the Food and Drug Administration delivered a split decision on a…
FDA greenlights medical device to combat bladder issues
You’re reading the web edition of STAT Health Tech, our guide to how tech is…
STAT+: FDA advisory panel to debate contentious data on Medtronic’s high blood pressure device
An advisory committee to the Food and Drug Administration will convene on Tuesday to evaluate…
FDA approves Pfizer’s RSV vaccine designed to protect newborns by immunizing parent
The Food and Drug Administration on Monday approved a Pfizer vaccine that aims to protect…
Kellogg’s is going to war over Mexico’s nutrition label rules. A similar fight is coming to the U.S.
MEXICO CITY — Kellogg’s is waging a war here over Tigre Toño and Sam el…
STAT+: FDA approves first treatment for ultra-rare bone disease
U.S. regulators on Wednesday approved the first treatment for an ultra-rare disease that causes people…
The latest recall of Philips ventilators reveals one death, two injuries
In March, Philips recalled more than 73,000 ventilators that absorbed dust and dirt into breathing…
STAT+: In a rare move, FDA threatens to fine a company for failing to report clinical trial results
For only the fifth time, the U.S. Food and Drug Administration recently threatened to fine…
STAT+: FDA warns AstraZeneca over misleading promotional materials for a COPD drug
The U.S. Food and Drug Administration scolded AstraZeneca for making misleading claims about the effectiveness…
Patient advocates warn FDA proposal on salt intake could do fatal harm to people with kidney disease
WASHINGTON — Patient advocates are warning that a recent proposal from the Food and Drug…
Opinion: Home blood pressure machines are often wrong. The FDA must speak up
Hypertension is considered to be the No. 1 risk factor for death globally. So it’s…
STAT+: In the case of a devastating disease, the FDA weighs an experimental drug’s muddled data and a desperate need
Emma Albee knows the experimental drug she takes is not a cure. It won’t allow…
Tuberculosis outbreak tied to bone grafts underscores shortcomings of testing
One person has died and at least four have been sickened by tuberculosis in infected…