CDC’s Messonnier: We can’t change the Covid-19 vaccine regimen unless we know it works
In an effort to stretch the supply of Covid-19 vaccines, some have advocated for further…
Category: government agencies
STAT+: Xavier Becerra’s 4 most urgent challenges as Biden’s soon-to-be HHS secretary
WASHINGTON — Xavier Becerra has survived the worst of a tense confirmation battle to become…
STAT+: Bipartisan group of former FDA commissioners pushes for strong tobacco regulation
WASHINGTON — A bipartisan cadre of FDA commissioners urged the Biden administration to get tough…
Virtual Event: Four former FDA commissioners discuss the agency’s future
Editor’s note: A livestream of the event will be embedded below at 2 p.m. ET….
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STAT+: Pharmalittle: Biden urged by former FDA commissioners to pick agency chief; Lilly reports more positive data for Covid-19 drug
Hello, everyone, and how are you this fine, sunny morning? The middle of the week…
STAT+: 6 former FDA commissioners push Biden to nominate a permanent chief
WASHINGTON — Six former FDA commissioners are urging President Biden to quickly nominate an FDA…
STAT+: Pharmalittle: Covid-19 forces FDA to postpone inspections; pharma urges Biden to reject WTO proposal
Rise and shine, another busy day is on the way. We can tell it is…
STAT+: Biden’s silence on an FDA nominee underscores how tough it is to fill that job
WASHINGTON — Nearly everyone here expected President Biden to move with record speed to nominate…
STAT+: FDA reviews accelerated approvals as two drug makers withdraw bladder cancer indications
For the second time in less than a month, a drug maker has pulled an…
CDC says fully vaccinated Americans can spend time together indoors and unmasked
WASHINGTON — People who have been fully vaccinated against Covid-19 can now spend time together…
STAT+: FDA releases a new plan to bring its data skills up to speed
When Ram Iyer started his new job at the Food and Drug Administration in 2020,…
STAT+: Janet Woodcock revolutionized the way the FDA reviews cancer drugs, inspiring her supporters and raising concerns for detractors
WASHINGTON — In 2000, the Food and Drug Administration approved just three cancer drugs. Last…
Andrew Cuomo’s Covid-19 nursing home fiasco shows the ethical perils of pandemic policymaking
WASHINGTON — The humbling of New York Gov. Andrew Cuomo on pandemic policy has been…
Listen: Covid vaccines for teens, Novavax’s remarkable rise, and the future of HHS
Why can’t kids get Covid-19 vaccines? Is there hope for biotech penny stocks? And when…
Opinion: Discarded drugs: a wasteful and costly problem that requires whole-of-government approaches
Controlling the rising costs of pharmaceuticals, particularly those administered by physicians, has been a top…
Opinion: CDC estimated a one-year decline in life expectancy in 2020. Not so — try five days
The Centers for Disease Control and Prevention made headlines last week when it announced that…
STAT+: Republicans’ surprising Becerra attack: He’s not sympathetic enough to pharma
WASHINGTON — Republican senators on Tuesday blasted President Biden’s health secretary nominee using an unexpected…
STAT+: Federal watchdog raises concerns about increasing telehealth fraud during pandemic
WASHINGTON — A federal government watchdog is sounding the alarm that Americans’ growing enthusiasm for…
Opinion: New CDC school opening guidelines fail to ‘follow the science’
President Biden vowed to “follow the science” in an effort to get kids back to…
Listen: Gene therapy’s safety scare, biotech’s brashest VCs, & the FDA’s uncertain future
How safe is gene therapy? Is there anything “unique” about venture capital? And who’s going…
Biden to nominate Brooks-LaSure to oversee CMS
WASHINGTON — President Biden plans to nominate Chiquita Brooks-LaSure, a health policy consultant and veteran…
STAT+: FDA warns AcelRx of misleading ads for its pain drug Dsuvia
The manufacturer of Dsuvia, a pain drug approved by the Food and Drug Administration amid…
STAT+: After a controversial Alzheimer’s drug review, FDA’s Woodcock rejects proposal to ‘firewall’ agency and drug companies
In response to criticism, a top Food and Drug Administration official maintained that creating a…
Opinion: The NIH needs to ensure that women are equally represented in grant funding decisions
For U.S. researchers, the room where it happens —”it” being decisions about funding — is…
Opinion: Dear NHS: You need a control arm for Grail’s cancer test
A simple blood test able to detect 50 different cancers is the grail of cancer…
STAT+: ‘A natural experiment’: Pandemic-driven drop in cancer screening may aid research on overdiagnosis
It’s counterintuitive, but catching cancer early isn’t always for the best. And the coronavirus pandemic…
The Biden administration is making nursing schools pay for a government mistake amid Covid-19
WASHINGTON — The federal government miscalculated funding for hospital-based nursing schools for nearly two decades,…
STAT+: STAT+ Conversations: A conversation on the FDA’s regulation of AI
Editors Note: A livestream of this conversation will be embedded below at 1:00p.m. ET. Every…
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STAT+: Woodcock vs. Sharfstein: A head-to-head comparison of Biden’s top choices for FDA commissioner
WASHINGTON — President Biden will soon have to nominate someone to helm the Food and…
STAT+: Dueling endorsements emerge for FDA commissioner: Woodcock or Sharfstein?
As the White House struggles to address the pandemic and other pressing health matters, a…
Opinion: Collaboration between the FDA and industry is essential to foster innovation in Alzheimer’s treatments
As the Food and Drug Administration moves closer to a decision about whether to approve…
STAT+: FDA blasts Keytruda data for new breast cancer indication as ‘questionable, immature, and unreliable’
Merck (MRK) may have readily turned its Keytruda cancer drug into a medical and financial…
STAT+: Explore STAT’s database of FDA-cleared AI tools
The Food and Drug Administration has cleared scores of AI tools for use in the…
Opinion: HHS’s ‘sunset rule’ will save money and lives
There has been a lot of hand-wringing lately over a new regulation from the Department…
STAT+: Advocacy groups urge Biden administration not to tap Woodcock as FDA commissioner
As the Biden White House attempts to fashion its health policies, a coalition of consumer…
Opinion: Governments’ alcohol subsidies are harmful to public health
Each January, millions of people around the world make resolutions to cut back on the…
STAT+: This professor wrote a manual for using a little-known federal law for lowering drug prices
One of the priorities of the new Biden administration is to tackle the cost of…
Opinion: The Biden-Harris FDA should make friends with independent researchers
Support for open science — accessible, collaborative, and radically transparent research done outside of traditional…
Opinion: The stakes for choosing the right FDA commissioner couldn’t be higher
An independent, credible, science-led Food and Drug Administration has long been vital to America’s public,…
FDA approves first monthly injectable medicine to treat HIV infection
In a move that could transform HIV treatment, the Food and Drug Administration has approved…
STAT+: Biden is set to block dozens of Trump’s last-minute health regulations
WASHINGTON — President Biden is set to freeze a spate of last-minute Trump administration regulations…
Biden, in inaugural address, pledges the U.S. ‘can overcome’ Covid-19
WASHINGTON — President Biden underscored his focus on Covid-19 on Wednesday, using key moments of…
Longtime Becerra aide and two health policy experts to be tapped for key posts
WASHINGTON — President-elect Biden and his top health deputies are expected to make a slew…
Opinion: Azar’s ‘Sunset Rule’ will bring a dangerous new dawn for health regulation
Alex Azar, secretary of the federal Department of Health and Human Services, spent his final…
STAT+: Will the FTC get tougher on pharma business practices under the Biden administration?
As the Biden administration begins setting priorities, the Federal Trade Commission is poised to take…
STAT+: After repeated delays, Trump’s HHS punts on oversight of a massive Covid-19 response fund for hospitals
WASHINGTON — The Department of Health and Human Services acted with lightning speed to send…
‘Slippery slope territory’: Health officials propose waiving regulatory review of medical AI tools
Days before leaving office, President Trump’s top health official is proposing to permanently exempt from…
Biden will mobilize FEMA, the National Guard, and pharmacies to ramp up vaccine distribution
WASHINGTON — President-elect Biden’s newly released vaccine distribution plan promises to dramatically increase the number…
Genome-sequencing pioneer Eric Lander to lead science policy for Biden
WASHINGTON — President-elect Biden on Thursday nominated Broad Institute president Eric Lander to serve as…
STAT+: Medicare Part D spent twice what the VA paid for the same drugs
Medicare Part D spent more than twice as much on hundreds of prescription drugs than…