Trump administration fires back at ousted vaccine expert as he testifies on his role in U.S. coronavirus response
WASHINGTON — The Trump administration accused a federal whistleblower Thursday of “one-sided arguments and misinformation”…
Category: government agencies
STAT Plus: Trump administration proposes a dramatic payment boost for CAR-T treatments under Medicare
WASHINGTON — The Centers for Medicare and Medicaid Services proposed a major payment bump for…
With little data, doctors struggle to decide which Covid-19 patients should get remdesivir
Now that the federal government has begun distributing the experimental Covid-19 drug remdesivir, hospitals are…
STAT Plus: A new Trump administration rule could increase out-of-pocket drug costs
Even as prescription drug costs remain an important pocketbook issue for many Americans, the Trump…
Vaccine expert says he was punished for raising concerns about Trump’s coronavirus response, nepotism
WASHINGTON — Rick Bright, the ousted head of the Biomedical Advanced Research and Development Authority,…
NIH announces $1.5 billion, ‘Shark Tank’-like initiative to accelerate Covid-19 testing
WASHINGTON — The National Institutes of Health on Wednesday announced a new $1.5 billion initiative…
.jpg)
Opinion: We need the real CDC back, and we need it now
As political leaders discuss relaxing social distancing restrictions and opening up the economy again, a…
STAT Plus: Gilead sues U.S., claiming it ‘secretly’ obtained patents on HIV research that led to Truvada
Gilead Sciences (GILD) has accused the U.S. government of breaching several contracts and “secretly” obtaining…
FDA’s Woodcock on authorizing emergency use for hydroxychloroquine: ‘We did the best we could’
Over the past few weeks, the Food and Drug Administration has been criticized for some…
Why was an unknown federal bureaucrat involved in Trump’s emergency hydroxychloroquine authorization?
WASHINGTON — Rick Bright, an otherwise unknown federal bureaucrat, burst onto the political stage this…
Opinion: Trump’s cuts to WHO funding: irresponsible, irrational, and simply wrong
The Covid-19 pandemic has shown us that an infectious disease outbreak in one corner of…
STAT Plus: Major health-record company drops opposition to federal data-sharing rule
After months of fierce opposition, the electronic health record company Epic said Thursday it is…
An ousted vaccine agency director offers an explosive, direct allegation: Trump is politicizing science
WASHINGTON — Rick Bright, the U.S. official who was ousted this week from a post…
Immunomedics wins FDA approval for new drug to treat aggressive form of breast cancer
Immunomedics secured U.S. approval on Wednesday for a new drug to treat women with a…
Director of U.S. agency key to helming vaccine development leaves role suddenly amid coronavirus pandemic
WASHINGTON — Rick Bright, one of the nation’s leading vaccine development experts and the director…
NIH Director Francis Collins on Tony Fauci, the WHO, and running a $39 billion research agency from home
WASHINGTON — Francis Collins hasn’t set foot on the National Institutes of Health’s campus in…
STAT Plus: An FDA tool for hastening approvals is not very useful for breast cancer drugs
Nearly two years ago, the Food and Drug Administration published a table of surrogate endpoints…
NIH partners with 16 drug companies in hopes of accelerating Covid-19 treatments and vaccines
WASHINGTON — The National Institutes of Health on Friday announced it would launch a sweeping…
Help wanted: Health agencies will need an army of coronavirus trackers
K.J. Seung is surprised to be hiring and training new workers in Boston. His public…
STAT Plus: Insurers, drug makers, and patient advocates blast two Trump proposals to drive down drug prices
WASHINGTON — The Trump administration has proposed modest steps this year to promote biosimilar and…
Who gets hospitalized for Covid-19? Report shows differences by race and sex
The first federal report on who requires hospital care for Covid-19 in the U.S. has…
‘We’re being put at risk unnecessarily’: Doctors fume at government response to coronavirus pandemic
LOS ANGELES — Even before the pandemic, burnout, anxiety, and disillusionment were already endemic in…
Opinion: CDC: remember who you are
Public health wins are quiet — the child born healthy, the loved one still safe,…
DEA moves to fight shortages of medicines needed for Covid-19 patients
The Drug Enforcement Administration is taking steps to permit increased production and importation of various…
Wealthy nations urged to embrace WTO deal and import meds made under compulsory licenses
In the latest effort to widen access to Covid-19 medical products, three dozen countries are…
STAT Plus: Immunomedics halts late-stage clinical trial, confirming drug benefit for aggressive type of breast cancer
Immunomedics is stopping a Phase 3 clinical trial due to “compelling evidence of efficacy” demonstrated…
This tiny federal agency was built to respond to a crisis like coronavirus. Now that it’s here, is BARDA ready?
WASHINGTON — It seems like an agency tailor-made for a crisis like the coronavirus pandemic….
White House expected to recommend all Americans wear cloth masks to prevent coronavirus spread
WASHINGTON — The White House is expected to announce a new policy, based on guidance…
STAT Plus: FDA closes review of Novartis data integrity scandal without punishing the drug maker
An embarrassing scandal that Novartis (NVS) endured over data integrity has quietly come to a…
STAT Plus: Congress set to overhaul the way the U.S. regulates over-the-counter drugs
WASHINGTON — The over-the-counter drug industry is about to get overhauled. Congressional lawmakers tucked a…
Opinion: A CDC veteran asks: Why is the agency ‘sitting on the sidelines’ in the fight against Covid-19?
The public health challenge of our generation is right in front of us. SARS-CoV-2 appears…
STAT Plus: The tables are turned: Chinese regulator scolds a U.S. company for drug-manufacturing problems
The shoe is on the other foot, so to speak. For the past few years,…
STAT Plus: An Indian drug maker is slammed by FDA for tossing ‘cartloads of trash bags’ filled with documents
Amid global anxiety over the novel coronavirus, a newly issued warning letter by the Food…
As public hungers for coronavirus tests, FDA warns new at-home kits are ‘unauthorized’
As a wave of at-home tests for coronavirus are coming on the market, federal regulators…
STAT Plus: Preventing other Shkreli-like debacles may not save the government much money
After Martin Shkreli took a 5,000% price hike on a decades-old medicine and thwarted rivals,…
Opinion: Covid-19 will worsen the opioid overdose crisis if we don’t prepare now
In cities across the country, morning is peak time at almost any opioid treatment program….
FDA moves to boost coronavirus testing capacity by giving states more power
In response to a dire shortage of tests for detecting the fast-moving coronavirus, the Food…
STAT Plus: Trump official behind health data rules has a message for privacy critics: Try helping patients, instead of your bottom line
For the past year, Don Rucker has been in the middle of one of the…
A quarantined Ted Cruz proposes to speed approvals for coronavirus drugs and vaccines
Although Sen. Ted Cruz (R-Texas.) is quarantined at home after coming into contact with someone…
STAT Plus: Danish regulator eyes sanctions — including prison time — against trial sponsors that fail to post results
In the latest effort toward greater clinical trial transparency, the Danish Medicines Agency is threatening…
NIH official suggests large gatherings should be canceled due to coronavirus outbreak
WASHINGTON — Anthony Fauci, the nation’s top infectious disease researcher, escalated his tone regarding the…
STAT Plus: Drug companies, Canadians, pharmacists and more blast Trump’s drug importation plan
WASHINGTON — The Trump administration is being flooded with opposition to its plan for allowing…
FDA halts inspections of foreign plants through April due to coronavirus
The ongoing spread of the novel coronavirus has prompted the Food and Drug Administration to…
Opinion: I thought I understood the Sacklers’ opioid empire. Startling documents from a whistleblower and declassified government files proved me wrong
What could possibly be new about the Sackler family, the billionaire owners of Purdue Pharma?…
The coronavirus outbreak has left medical supplies in short supply. Is the nation’s emergency stockpile ready to help?
WASHINGTON — The U.S. government has a secretive, $7 billion stash of emergency medical equipment…
STAT Plus: Congress asked the FDA to explain its rules on CBD — but its new report offers little clarity
WASHINGTON — A new report on cannabidiol, or CBD, from the Food and Drug Administration,…
STAT Plus: FDA petitioned to recall batches of metformin diabetes pill over a possible carcinogen
An online pharmacy is calling for U.S. regulators to recall batches of the metformin diabetes…
Trump administration expands coronavirus travel ban to include Iran
WASHINGTON — The Trump administration on Saturday announced it would expand an existing ban on…
The FDA identifies its first drug shortage due to coronavirus but won’t name the medicine
For the first time since the coronavirus outbreak began, the Food and Drug Administration has…
STAT Plus: AI has arrived in medical imaging. Now the FDA needs to monitor its impact on patients
BETHESDA, Md. — This is the moment of truth for the FDA’s regulation of artificial…