Failed clinical trials don’t always spell doom for a new drug. Here’s why
This article was adapted from STAT’s latest report, “Failed trial, successful drug: how a negative…
Category: FDA
STAT+: More regulation could be coming for drug ads
WASHINGTON — Government regulators may soon decide whether to crack down on distracting visuals in…
STAT+: FDA approves Sage Therapeutics’ rapid-acting medication for postpartum depression but not major depression
The Food and Drug Administration on Friday approved a new, rapid-acting medicine made by Sage…
STAT+: Intas Pharma employee used acid to destroy manufacturing records at troubled plant
Last November, an employee at Intas Pharmaceuticals, which makes several widely used chemotherapies that are…
STAT+: Vivek Ramaswamy wants to ‘gut’ the FDA. His claims don’t hold up to scrutiny
STAT readers know Vivek Ramaswamy from his time as the founder of the biotech conglomerate…
STAT+: Gene therapy is in crisis. For nine hours, the field’s leading minds looked for a solution
WASHINGTON — Jennifer Puck has successfully treated 10 children with a gene therapy for a…
STAT+: FDA inspection underscores problem at major U.S. compounder behind hospital drug recalls
One of the largest compound pharmacy operations in the U.S. recently recalled a slew of…
STAT+: Pfizer says most tornado damage at key plant hit warehouse, but finished drugs also impacted
Pfizer says a tornado that ripped through a key manufacturing plant in North Carolina does…
STAT+: FDA official pushes for a dedicated emerging pathogens team to prepare for the next pandemic
WASHINGTON — A top Food and Drug Administration official wants Congress to dedicate full-time staff…
STAT+: European regulator will review study data from contract research organization due to ‘serious concerns’
In the latest melee over the safety of prescription medicines, the European Medicines Agency is…
STAT+: Damages from tornado at Pfizer plant could compound challenges of drug shortages
The tornado that struck parts of North Carolina on Wednesday not only damaged the immediate…
STAT+: House committee probes FDA inspections of pharma plants in China and India
A Congressional committee is demanding the U.S. Food and Drug Administration provide detailed information about…
STAT+: Bernie Sanders adds three drug shortage policies to pandemic preparedness bill
WASHINGTON — Senate health committee Chair Bernie Sanders added three drug shortage measures to a…
Hearing aids may slow mental decline in those at higher risk of dementia, study finds
Doctors have long suspected that hearing loss in older adults hastens dementia, the cognitive decline…
Nearly 8,000 blood tests recalled over risk of missed heart attack diagnosis
QuidelOrtho has recalled nearly 8,000 potentially faulty blood tests meant to help doctors quickly determine…
STAT+: Argenx antibody drug significantly slows progression of nerve disorder that robs patients of muscle strength
Belgian drugmaker Argenx said Monday that its antibody treatment called Vyvgart significantly delayed the progression…
FDA approves first over-the-counter birth control pill
In a highly anticipated move, the U.S. Food and Drug Administration approved the first over-the-counter…
Three reasons why Chuck Schumer’s crusade against Logan Paul’s energy drink will likely fizzle out
WASHINGTON — Sen. Chuck Schumer (D-N.Y.), the most powerful person in the U.S. Senate, wants…
White House announces new plan to address the growing threat of xylazine in overdose crisis
The White House on Tuesday unveiled a new plan to address the growing presence of…
Opinion: We finally have new Alzheimer’s drugs. How do we decide who gets them?
The recent FDA approval of Leqembi, the latest anti-amyloid drug, is undoubtedly a breakthrough for…
Opinion: Listen: Is the medical system ready for Alzheimer’s drugs that work?
An effective treatment for Alzheimer’s disease has long been a holy grail in the pharmaceutical…
STAT+: Medicare’s new proposal to cover medical devices draws a mixed reaction
The medical device industry is split on whether a proposed new Medicare reimbursement pathway will…
STAT+: BioMarin wins approval for gene therapy to treat hemophilia A
The Food and Drug Administration on Thursday approved a gene therapy to treat people with…
STAT+: Drug wholesaler owner indicted for role in diverting Gilead and J&J HIV medicines
The owner of a pharmaceutical wholesaler has been indicted for his alleged role in distributing…
STAT+: FDA issues warning to wholesaler sued by Gilead and J&J for distributing counterfeit medicines
A year after two major drugmakers sued a wholesaler for its alleged role in distributing…
STAT+: FDA rejects Intercept’s NASH drug, prompting a pivot
The Food and Drug Administration rejected Intercept Pharmaceuticals’ investigational treatment for NASH on Thursday, derailing…
Opinion: The FDA’s approval of a new gene therapy for Duchenne muscular dystrophy won’t help me — but it gives me hope
When I was diagnosed with Duchenne muscular dystrophy 20 years ago, there was no hope….
FDA moves to stop vape shops from selling Elf Bar, Esco Bars
WASHINGTON — The Food and Drug Administration is ramping up its efforts to force vape…
STAT+: The FDA is testing new nutrition labels on the front of food packages
WASHINGTON — The FDA wants to make it easier for consumers to know if the…
Opinion: How to separate sound wellness solutions from seductive snake oil
When pandemic lockdowns prevented access to traditional health care facilities, the demand for alternative and…
Opinion: The FDA needs a risk evaluation and mitigation strategy for Alzheimer’s drug lecanemab
Over the past several months, my conversations with colleagues in the Alzheimer’s field have featured…
STAT+: Federal advisory group rejects proposal to make medical device tracking easier
Every medical device has its own unique code, allowing manufacturers to keep track of their…
STAT+: Pharmalittle: U.S. Chamber sues over Medicare price negotiations; FDA seeks new supplier for scarce cancer drug
Good morning, everyone, and welcome to another working week. We hope the weekend respite was…
Top health officials call for more research to support fentanyl test strips
The government’s top addiction scientists and key public health officials are calling for more research…
STAT+: FDA panel unanimously endorses Eisai’s Alzheimer’s drug
Expert advisers to the Food and Drug Administration on Friday voted unanimously in favor of expanding…
FDA’s letter to medical device maker iRhythm is a warning for the industry
Heart monitoring company iRhythm is in hot water with the Food and Drug Administration, which…
STAT+: Tracking the FDA advisory panel on Eisai and Biogen’s treatment for Alzheimer’s disease
The Food and Drug Administration is convening a meeting of outside experts on Friday to…
Listen: Merck v. USA, the best of ASCO, and Leqembi at the FDA
Are drug prices protected by the Constitution? Will Medicare embrace Alzheimer’s disease treatments? And should…
STAT+: Sen. Cassidy wants to put a stop to FDA delays in drug review process
WASHINGTON – Sen. Bill Cassidy (R-La.) is looking into ways to speed up the Food…
STAT+: ‘We don’t agree’ on drug pricing policy, FDA chief tells biotech leaders
BOSTON — The drug industry has spent the past year speaking against new mechanisms that…
Akili Interactive releases video game treatment for adult ADHD with no prescription required
Following positive top-line data released in May, Akili Interactive announced it will release its video…
STAT+: With digital therapeutics businesses flailing, the industry descends on D.C. to make the case for coverage
This week, the leading advocacy group for digital therapeutics companies is gathering the industry’s leaders…
STAT+: FDA will allow troubled chemotherapy maker to resume distribution of cancer drugs in short supply
After finding a “cascade of failures” at a manufacturing plant run by a key chemotherapy…
STAT+: More than 200 FDA staffers have retired in less than a year
WASHINGTON — More than 230 people have retired from the Food and Drug Administration since…
STAT+: FDA removes neurologist with financial ties to Eisai and Biogen from Alzheimer’s advisory panel
The Food and Drug Administration has removed a neurologist with financial ties to Biogen and…
STAT+: FDA oncology head wants advisory panels to keep voting on new drugs
CHICAGO — As commissioner of the Food and Drug Administration, Robert Califf has made clear…
STAT+: Lured by a bigger payday, a medical device maker sold fake plastic parts. Many were implanted in chronic pain patients
Stimwave’s pitch was alluring. As a startup tackling chronic pain with nerve-stimulating devices, it promised…
STAT+: Neuralink can now study its brain implant in humans, but it’s still catching up to its peers
Neuralink can now study its brain implant in humans after securing a go-ahead from the…
Omada tackles obesity drugs, Boston Scientific nixes deal, and Microsoft health exec on GPT
You’re reading the web edition of STAT Health Tech, our guide to how tech is…
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FDA budget battles, prisons’ sobering Covid response & BIO’s CEO search is on
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