STAT+: Immunogen wins FDA approval for targeted medicine to treat advanced ovarian cancer
The Food and Drug Administration on Monday approved a new treatment for patients with advanced…
Category: FDA
STAT+: FDA panel votes against Veru’s drug for severe Covid
An FDA advisory panel voted 5-to-8 to recommend rejecting a new drug for patients hospitalized…
Here’s why we’re not prepared for the next wave of biotech innovation
The first time I remember hearing the words “biology’s century,” it was a sales pitch….
FDA panel asks for improvements in pulse oximeters
A Food and Drug Administration advisory panel suggested Tuesday that the agency improve how it regulates…
Pulse oximeters and their inaccuracies will get FDA scrutiny today. What took so long?
A Food and Drug Administration advisory committee Tuesday will take up the issue of whether…
STAT+: Pharmalittle: FDA advisers vote down pediatric brain cancer drug; AbbVie drops out of psoriasis partnership
Good morning, and welcome to a spooky edition of Pharmalittle. It’s Jason Mast here, filling…
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STAT+: Pharmalittle: Italy probes Pfizer over profit transfers; FDA postpones meeting for OTC birth control pill
Rise and shine, another busy day is on the way. However, this is also shaping…
STAT+: Epic’s overhaul of a flawed algorithm shows why AI oversight is a life-or-death issue
Epic, the nation’s dominant seller of electronic health records, was bracing for a catastrophe. It…
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FDA’s vaccines chief sees possibility of more Covid boosters — sooner than he’d like
Peter Marks, who leads the Food and Drug Administration’s vaccines operation, is still losing sleep…
BU’s Covid tinkering, FDA on trial, & why it’s hard to take drugs off the market
What happens when approved drugs turn out not to work? Is it OK to make…
Opinion: What the Makena vote means about accelerated approval, trust, and the FDA
On Wednesday, the FDA advisory committee that oversees obstetrics, reproductive, and urologic drugs voted 14-1…
FDA authorizes booster shot for Novavax’s Covid-19 vaccine
The Food and Drug Administration announced Wednesday that it has authorized a booster shot for…
STAT+: FDA panel votes that a controversial premature birth medication should be withdrawn
After an extraordinary three-day hearing, an expert panel of advisers to the U.S. Food and…
Listen: What makes food ‘healthy’ and why we don’t prioritize nutrition
After years of deliberation, the FDA recently announced a new set of rules it proposes…
Opinion: STAT+: How digital health innovators can successfully navigate evolving FDA regulations
In the rapidly changing landscape of digital health, innovation has often outpaced regulations, especially for…
FDA, DOJ sue 6 vape shops for ignoring warnings about selling illegal products
WASHINGTON — The Biden administration is suing six vape shops after the companies ignored Food…
Biden officials scramble for a backup as Covid variants threaten a key therapy for immunocompromised people
WASHINGTON — Biden health officials are bracing for the prospect that the country’s sole preventive…
STAT+: Differences in countries’ regulations keep some cell and gene therapies from reaching patients
CARLSBAD, Calif. — Biotech companies developing cutting-edge cell and gene therapies often are tripped up…
Opinion: The cost of doing nothing: Congress is missing a rare opportunity to improve FDA policies and help people with deadly illnesses
Congress has taken the necessary step of including critical reauthorizations for the Prescription Drug User…
Opinion: FDA’s plan to define “healthy” for food packaging: Better than the existing labeling anarchy, but do we really need it?
The FDA has announced the set of rules it proposes to enforce for manufacturers to…
The U.S. is terrible at keeping businesses from worsening public health, experts say
WASHINGTON – Here in the U.S., it’s “in” to study the social determinants of health….
Listen: A surprise success in Alzheimer’s and how FDA history seeded modern controversy
Does the latest Alzheimer’s disease drug actually work? When does the FDA call in security?…
FDA proposes new rules for which foods can be called ‘healthy’
The Food and Drug Administration wants to update its rules for which foods can be…
STAT+: Top FDA official acknowledges agency’s slow process for reviewing health app updates
The Food and Drug Administration’s approach to reviewing updates to software products is far slower…
STAT+: Democrats concede to clean user fee agreement to fund FDA
WASHINGTON — Democrats have conceded to Republican demands and agreed to fund the Food and…
STAT+: Catalent is scolded by FDA for quality control issues at a plant that helps make Covid-19 vaccines
Catalent, one of the largest contract manufacturers in the pharmaceutical industry, was cited by the…
Coors, Mondelez, and other big food companies want to sell CBD-filled food and drinks. The FDA is staunchly opposed
WASHINGTON — Major food makers are ready to cash in on selling CBD-filled foods and…
STAT+: Patients for Affordable Drugs taps new leader
WASHINGTON — One of Washington’s most prominent drug pricing patient groups is tapping an advocate who…
Opinion: FDA and USDA need to get on board with the CDC about reducing antibiotic use in raising animals for food
The overuse of antibiotics and other antimicrobials in raising farm animals for food may not…
STAT+: FDA funding negotiations heat up ahead of September deadline
WASHINGTON — Negotiations are intensifying over massive, multibillion-dollar legislation to fund the Food and Drug…
Illumina’s $8 billion limbo, a new treatment for ALS, & Emirati biotech funding
Is Illumina a victim of its own success? What makes the FDA change its mind?…
STAT+: In reversal, FDA advisers vote a second time to support approval of Amylyx’s drug for ALS
At the end of an unusual and dramatic meeting on Wednesday, an independent panel of…
Opinion: Listen: A doctor with ALS laments the slow pace for drug approval
During his long career as a pediatric oncologist and cancer researcher, William Woods thought highly…
FDA authorizes Pfizer and Moderna Covid boosters targeted against Omicron strains
The Food and Drug Administration on Wednesday authorized new Covid booster shots from Moderna and…
Opinion: The FDA is at a crossroads for reducing tobacco-related disease and death
The U.S. is at a crossroads for tobacco use, the country’s leading cause of preventable…
The FDA stands by as the vaping industry flouts its orders
WASHINGTON — The Food and Drug Administration has spent more than four years trying to…
STAT+: FDA scolds Sun Pharma for allegedly backdating documents and fudging records for collecting drug samples
Sun Pharmaceutical, which is one of the largest purveyors of generic drugs, allegedly falsified various…
Listen: Private equity in autism care, a watershed FDA approval, and the future of ALS treatment
How did autism care become a big business? Can gene therapy be profitable? And whatever…
STAT+: Bluebird wins U.S. approval for a gene therapy to treat patients with a rare blood disorder
The Food and Drug Administration on Wednesday approved a new treatment that delivers a potentially…
Opinion: As a pediatric cancer researcher, I admired the FDA. Then I got ALS
Amyotrophic lateral sclerosis (ALS), as I have unfortunately come to learn, is a terrible disease…
STAT+: Brainstorm to seek FDA approval for ALS stem-cell treatment, despite agency objections
Last year, the Food and Drug Administration issued a rare public statement to inform the…
STAT+: A treatment for monkeypox was approved under the FDA’s ‘Animal Rule.’ Here’s what that means
Take a look at the list of conditions that have treatments available thanks to what’s…
Opinion: FDA needs to fully review ACAM2000 before allowing its widespread use as a monkeypox vaccine
As the United States grapples with monkeypox, which has been declared a public health emergency,…
Listen: Helen Branswell on monkeypox, plus: an FDA controversy and fake Alzheimer’s data
Can monkeypox be contained? Are snortable Covid-19 vaccines on the way? And when is a…
FDA weighs oversight changes after Juul, formula troubles
WASHINGTON — The head of the Food and Drug Administration said Tuesday he has commissioned…
STAT+: The politics of passing a major FDA funding bill just got complicated
WASHINGTON — For the last six months, Congress seemed to be sailing towards the uncharacteristically…
Durbin, Collins blast FDA for failure to ban certain synthetic e-cigarettes
WASHINGTON — Two key senators say the FDA “appears to be on the brink of…
FDA appears to hold off on crackdown on synthetic nicotine products, despite calls from Congress
WASHINGTON — Congress gave the Food and Drug Administration a clear directive to crack down…
STAT+: In a high-profile misstep, the FDA backtracks on its ban on Juul
WASHINGTON — The FDA suddenly reversed course this week on its efforts to ban Juul…
STAT+: What we know — and what we may never know — about why the FDA banned Juul
WASHINGTON – Even some of the nation’s top tobacco experts were surprised by the Food…