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FDA approves Novavax Covid vaccine after delay
Helen Branswell covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Follow her on Mastodon and Bluesky. You can reach Helen on Signal at hbranswell.01. The Food and Drug Administration has finally approved Novavax’s Covid-19 vaccine, but in doing so has placed restrictions on it that its two competitors in […]
ASGCT news: Chatter about Vinay Prasad, and newborn screening
NEW ORLEANS — Greetings from the home stretch of American Society of Gene and Cell Therapy conference, where everyone is still talking about Baby KJ and no one wants to talk about Vinay Prasad. The Vinay Prasad in the room Last year, hundreds of people poured in to see Peter Marks, the FDA’s head of […]
The FDA must earn trust on AI in product reviews
In an industry known for its caution, the Food and Drug Administration’s decision to rapidly deploy generative AI across all medical product review offices by the end of June is a rare and seismic move. It’s bold. It’s ambitious. And if implemented well, it could mark the beginning of a desperately needed transformation in how we bring […]
How most-favored nation drug pricing could backfire
The Trump administration faces a huge task under the president’s latest executive order: develop pricing targets in the next 30 days for thousands of drugs to equalize what Americans pay compared with patients overseas. They can accomplish his larger goal by embracing this opportunity to bring some rational thinking to the drug pricing system. They […]
STAT+: Cassidy set to ask RFK Jr. to explain his health department overhaul
WASHINGTON — The Republican leader of the Senate’s health panel plans to ask Robert F. Kennedy Jr. to explain the sweeping changes across the federal health agencies he oversees, in a long-awaited hearing scheduled for Wednesday afternoon. Sen. Bill Cassidy (R-La.) will ask Kennedy to address worries that the overhaul across the Department of Health and […]
Former CDC director on what new docs, scientists need to know
On Monday, May 12, former CDC Director Rochelle Walensky delivered the below commencement address at the WashU School of Medicine. One of my first tasks even before my tenure began as director of the Centers for Disease Control and Prevention was to pen an op-ed for the New York Times. It said, “I will lead […]
House GOP releases plans to reshape Medicaid
WASHINGTON — House Republicans are proposing cutting some of the federal Medicaid funding that goes to states that provide health coverage to undocumented immigrants. The policy was included in House Republicans’ plan for reducing Medicaid spending, released late Sunday by the Energy and Commerce Committee. The committee is holding a mark-up Tuesday of its share […]
The pain of even ‘mild’ cases of measles, pertussis, and more
When I was recently at the vet’s office, I started eavesdropping a little on the conversation between two older women. When they started talking about the measles outbreak in Texas, I couldn’t help it. I joined in. One of the women, who wore thick glasses, shared that she had lost much of her sight to […]
First at-home test kit for cervical cancer approved by the FDA
WASHINGTON — U.S. regulators have approved the first cervical cancer testing kit that allows women to collect their own sample at home before shipping it to a laboratory, according to a medical device company. Teal Health said Friday the Food and Drug Administration approved its Teal Wand for home use, offering a new way to collect vaginal […]
As Trump attacks on Harvard intensify, researchers scramble
What would Harvard University be without the money the federal government has provided over decades to underwrite its vast research initiatives? That’s the existential, $9 billion question facing the Harvard community after the Trump administration’s most recent threat in its confrontation with the university: Harvard will not receive any new federal research grants unless and until it […]