STAT+: How digital therapeutics companies are improvising when insurance coverage isn’t guaranteed
For years, the playbook for many companies that wanted to market digital therapeutics was stupid…
Category: FDA
STAT+: FDA expands approval of CRISPR-based medicine to treat beta thalassemia
The Food and Drug Administration on Tuesday approved a CRISPR-based medicine to treat beta thalassemia,…
The four biotech stories you need to read this morning
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STAT+: Many doctors are in the dark about how FDA approves devices and drugs, survey finds
In her final presentation for health policy class at the University of Chicago, first-year medical…
Novartis reportedly decides to pass on Cytokinetics
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The highs — and lows — of JPM 2024 you should pay attention to
In honor of JPM Week, you’re reading a special edition of our biotech newsletter, The…
GLP-1 drugs not linked to suicidal thoughts, FDA’s early review finds
A preliminary evaluation by the Food and Drug Administration did not find evidence that GLP-1…
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JPM Day 2 has arrived. Here are the can’t-miss moments of the event so far
In honor of JPM Week, you’re reading a special edition of our biotech newsletter, The…
Anthony Fauci talked Covid in Congress in a nine-hour, closed-door grilling — and that was just day one
You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and…
STAT+: HHS’s Xavier Becerra, once an ‘invisible’ secretary, is racing to cement a clearer legacy
WASHINGTON — He’s been called the “invisible” secretary. So far removed from the White House…
The Afghan father aided U.S. soldiers. Now Texas Medicaid won’t pay for his son’s gene therapy
On a sweltering day in August 2021, as the engines of a hulking C-17 cargo…
STAT+: Florida faces ‘complicated road’ before actually importing drugs from Canada, expert says
Last week, the Food and Drug Administration granted Florida permission to import medicines from Canada,…
STAT+: Backed by Mayo Clinic and Microsoft, a nonprofit forms to test AI tools used in health care
A group of academic hospitals and technology companies will form a new nonprofit venture to…
Why did Allogene cancel two clinical trials for its off-the-shelf cell therapy?
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STAT+: FDA is blasted by advocates for pursuing a deal with data provider that has ties to opioid makers
Several advocacy groups are blasting a Food and Drug Administration proposal to work with a…
STAT+: Consumer health advocate Sid Wolfe was a thorn in the side. We’re all the better as a result
The first phone call came some time in late 1996. “Ed, I’d like to introduce…
Opinion: There’s a less intimidating alternative to EpiPens for dangerous allergic reactions. Why won’t the FDA approve it?
My son Thomas has carried around a needle since he entered kindergarten at the age…
STAT+: 3 FDA staffers to watch in 2024
WASHINGTON — The Food and Drug Administration has a lot on its plate in 2024…
Opinion: STAT readers on patient advocacy, the utility of diagnostic tests, and more
STAT now publishes selected Letters to the Editor received in response to First Opinion essays…
STAT+: FDA alters warning label for Carvykti CAR-T, although link to secondary cancers is unclear
The Food and Drug Administration issued a change to the warning label for Legend Biotech…
The clock is ticking, and cytokinetics is running out of December
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FDA approves AstraZeneca, Ionis treatment for rare nerve disease
The Food and Drug Administration approved a novel medicine for a rare and devastating nerve…
Morning Rounds: Why health care costs are nearly a fifth of the GDP
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BioMarin appeases an activist
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STAT+: Medical marijuana companies are using pharma’s sales tactics with little of the same scrutiny
WASHINGTON — Medical marijuana companies sell medicine, just like pharmaceutical companies. But they’re not playing…
STAT+: Drugs are still mostly tested in white men. Will the FDA change that next year?
WASHINGTON — Sometime next year drug and medical device companies will have to tell the…
The legal pathway for experimental, ultra-rare disease treatments is rocky and expensive
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FDA chastens pet companies over antibiotics
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STAT+: In response to criticism, FDA publishes new database of wayward clinical trial sponsors
In a bid toward greater transparency, the U.S. Food and Drug Administration earlier this month…
STAT+: Why FDA product recalls have spiked in recent years
Either American products are getting worse, or scrutiny over their safety is getting tougher. Whichever…
Opinion: In mifepristone case, the Supreme Court must affirm the FDA’s authority. Medical innovation is at risk
On Wednesday, the Supreme Court announced it will soon weigh in on a case that…
Supreme court will decide abortion pill access
WASHINGTON — The Supreme Court agreed Wednesday to take on whether Americans can access a…
The biotech news you missed from the weekend
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STAT+: Was CAR-T therapy a bystander or driver of lymphoma? Researchers examine first published case
SAN DIEGO — Researchers on Saturday presented an unusual case of a T cell lymphoma…
STAT+: Tough road ahead for Bluebird Bio despite FDA approval for sickle cell therapy
The Food and Drug Administration’s approval on Friday of two gene therapies for sickle cell…
CRISPR is about to make history. Here’s the 5-minute rundown of what to expect
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White House delays menthol cigarette ban, alarming anti-smoking advocates
White House officials will take more time to review a sweeping plan from U.S. health…
Morning Rounds: Couples share high blood pressure, and other health stories you should read today
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Why Cerevel Therapeutics has risen 50% in three days without changing anything
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Carmot’s chance of beating the odds in the biotech market just ended
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STAT+: Cancer drug shortages won’t get better under Biden’s latest plan
WASHINGTON — President Biden’s new plan to curb drug shortages by boosting domestic drug production…
STAT+: Official: FDA needs staff influx to meet gene therapy needs
WASHINGTON — The Food and Drug Administration needs dozens more reviewers if it wants its…
STAT+: FDA efforts to oversee foreign drug manufacturing remain inadequate to ensure safety, analysis finds
In the wake of the Covid-19 pandemic, the Food and Drug Administration inspected far fewer…
Novartis is building a new radioligand plant in China
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Opinion: A well-meaning FDA policy is a threat to pediatric cancer treatment
The medical community today faces a deceptively simple question: How quickly should we act when…
Johnson & Johnson bets heavy on AI-driven drug discovery
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Do GLP-1s have a future treating alcoholism?
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Opinion: Diagnostic tests for rare conditions present a mathematical conundrum
Worried about your health? You can now avail yourself of noninvasive diagnostics that claim to…
STAT+: FDA chief scientist to replace Woodcock
WASHINGTON — The Food and Drug Administration’s chief scientist will replace retiring Janet Woodcock as principal…
Flagship Pioneering crosses the pond, opens a European front
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