The Food and Drug Administration

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FDA Approves New 3-in-1 Combo Pill for High Blood Pressure

June 11, 2025 – The FDA has approved a new pill for adults with high blood pressure (hypertension) that combines three medicines in one. Available in one regular and two lower doses, it offers a convenient option for treating hypertension, which affects nearly half of the adults in the U.S. and raises their risk of stroke and heart failure.

https://www.webmd.com/hypertension-high-blood-pressure/news/20250611/fda-approves-new-3-in-1-combo-pill-for-high-blood-pressure?

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FDA Approves Revolutionary Schizophrenia Drug

Sept. 27, 2024 – In a breakthrough for people living with schizophrenia, the FDA has approved a new oral medication for adults. Unlike traditional antipsychotic drugs, the medication, which will be marketed under the name Cobenfy, targets a different pathway in the brain, offering new hope for treatment.

https://www.webmd.com/schizophrenia/news/20240927/fda-approves-revolutionary-schizophrenia-drug?

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FDA Greenlights New Treatment for Advanced Blood Cancer

July 3, 2025 — A new treatment has received a quick federal nod for a common blood cancer, which could affect more than 36,000 people and result in around 12,000 deaths in the U.S. this year alone. 

https://www.webmd.com/drugs/updates/fda-oks-lynozyfic-multiple-myeloma?

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FDA OKs First-of-Its-Kind Lung Cancer Pill

July 7, 2025 – The FDA has granted quick approval to a first-of-its-kind pill for a type of lung cancer known as non-small-cell lung cancer (NSCLC). 

https://www.webmd.com/drugs/updates/fda-oks-first-of-its-kind-lung-cancer-pill?

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> Food and Drug Administration approves blue color additive derived from gardenia fruit as part of larger push to remove synthetic dyes from American diets (More) | Dozens of ice cream makers, representing roughly 90% of the US market, pledge to stop using artificial dyes by 2028 (More)

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The Food and Drug Administration authorized Juul to continue selling its signature e-cigarettes on the US market yesterday, as well as tobacco- and menthol-flavored refill cartridges. The decision ends three years of limbo after the federal regulator banned the company's products in 2022, then paused the ban pending further scientific review. The company’s fruit-flavored products remain banned.

 

The FDA determined the benefits to adult smokers seeking to quit traditional cigarettes outweigh the public health risks, including to youth. Since Juul entered the vaping market in 2015, its fruit-flavored nicotine pods and slim vaporizers fueled a spike in underage vaping. E-cigarette use increased from 220,000 high schoolers in 2011 to 3.1 million by 2018. The company agreed in 2022 to pay nearly $440M to settle a lawsuit alleging it intentionally marketed to youth.

 

While Juul held roughly 70% of the US e-cigarette market share in 2018, the company today holds roughly 18%, falling behind competitors Vuse and Geek Bar. Learn about Juul’s rise and struggles here.

ps:What a crock of Bull Manure!!!!!

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FDA names former pharmaceutical company executive to oversee US drug program

The Food and Drug Administration on Monday named a longtime pharmaceutical executive to run the agency’s drug program, the latest in a string of leadership changes at the agency. Read More.

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FEMA

The head of FEMA’s Urban Search and Rescue branch resigned on Monday. Ken Pagurek’s departure comes less than three weeks after a delayed FEMA response to catastrophic flooding in central Texas that was caused by bureaucratic hurdles. Pagurek told colleagues that he was frustrated by the Trump administration’s efforts to dismantle FEMA, but the delay in approval for his team to swiftly respond to the flooding was the tipping point that led to his decision. Pagurek, who spent more than a decade with FEMA’s Urban Search and Rescue branch, including about a year as its chief, joins dozens of other high-ranking officials to leave the agency since Trump took office.

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FDA vaccine chief leaving agency after less than 3 months

Dr. Vinay Prasad, the Food and Drug Administration’s polarizing vaccine chief, is leaving the agency after a brief tenure that drew the ire of biotech executives, patient groups and conservative allies of President Donald Trump. Read More.

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FDA's new expert panels are rife with financial conflicts and fringe views

The FDA has more than 30 panels of experts specializing in drugs, vaccines and other products. But increasingly, the agency isn’t calling them. Instead, FDA Commissioner Marty Makary is holding ad hoc sessions with outside experts who often have contrarian views and financial interests in the topics under discussion. Read More.

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New Drug Approved for Migraine Treatment

Nurtec ODT (rimegepant) is a new treatment approved by the US Food and Drug Administration (FDA) in May 2021. This is the first oral treatment option to treat acute migraine attacks, though the FDA also approved the drug for preventive treatment. Its approval is groundbreaking for migraine treatment. 

https://www.webmd.com/migraines-headaches/features/cm/new-drug-approved-migraine-treatment?

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FDA approves updated COVID-19 shots with limits for some kids and adults

WASHINGTON (AP) — U.S. regulators approved updated COVID-19 shots Wednesday but limited their use for many Americans — and removed one of the two vaccines available for young children.

https://apnews.com/article/vaccines-covid-shots-fda-kennedy-pfizer-children-9ce19908ae7afb354732aa162fd28532?

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Autism Guidance Released

Federal officials yesterday announced a possible association between the development of autism and a pregnant individual's use of acetaminophen, the active ingredient in the common over-the-counter pain reliever Tylenol. They recommended pregnant individuals limit use of the drug to cases such as high fever or severe pain.  The Food and Drug Administration said it will update safety labels with the risks of acetaminophen. However, the agency added that while there may be an association between autism and the drug, current scientific evidence has not established a causal relationship. Scientists have researched a potential link between autism and acetaminophen for years, but studies have delivered mixed results. The FDA also approved leucovorin as a possible treatment for autism symptoms. Autism is a developmental condition affecting how people communicate, interact socially, and process information. Reported autism diagnoses in the US (see CDC data) have risen since 2000, with about 1 in 31 children and 1 in 45 adults diagnosed today. Factors include improved diagnostic criteria and expanded screening.

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FDA approves another generic abortion pill, prompting outrage from conservatives Federal officials have approved another generic version of the abortion pill mifepristone, a regulatory formality that quickly triggered pushback from anti-abortion groups and politicians aligned with the Trump administration. Read more.

Why this matters: Drugmaker Evita Solutions announced on its website that the Food and Drug Administration signed off on its low-cost form of the pill, which is approved to end pregnancies through 10 weeks.   Students for Life Action, which opposes abortion, in a statement Thursday called the approval “a stain on the Trump presidency and another sign that the deep state at the FDA must go.” Republican Sen. Josh Hawley of Missouri also criticized the move in a post on X, stating, “I have lost confidence in the leadership at FDA.”

RELATED COVERAGE ➤ Pope intervenes in US abortion debate by raising what it really means to be ‘pro-life’   Maine clinics also hit by cuts that targeted Planned Parenthood plan to halt primary care

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Is Your Medication Made in a Contaminated Factory? The FDA Won’t Tell You.

They were the sort of disturbing discoveries that anyone taking generic medication would want to know.

https://www.propublica.org/article/fda-hides-drug-names-contaminated-factories?

Here’s What Happened When ProPublica Reporters Tried to Find Out Where a Popular Prescription Drug Was Made

ProPublica wanted to know something simple: Where a widely used generic drug was made and whether that factory had any quality problems. Instead, we found ourselves navigating a labyrinth of company names and complex databases that few regular consumers would even know exist.

https://www.propublica.org/article/fda-transparency-atorvastatin-prescription-explainer?

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New Menopause Drug

The Food and Drug Administration approved a new drug to treat women during menopause Friday. The drug—elinzanetant, produced under the brand name Lynkuet—is one of the few nonhormonal treatments for symptoms including night sweats and hot flashes. Roughly 80% of women experience vasomotor symptoms, which can last for an average of seven to 10 years. As estrogen levels decrease during menopause (see 101), nerves in the hypothalamus region of the brain—which regulate body temperature—become hyperactive. Hormonal treatments typically involve a combination of estrogen and progesterone. This drug is the first nonhormonal option targeting two brain receptors involved in regulating temperature. In a Phase 3 clinical trial, 73% of women experienced reduced symptoms, compared to 47% using a placebo.  Bayer's once-a-day pill will be publicly available next month. A 30-day supply costs $625, though insurance could lower the monthly cost to as little as $25 per month.

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Drug prices

The US Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs. The changes are intended to increase competition and lower drug costs for Americans.

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? New FDA turmoil

Illustration: Allie Carl/Axios

A weekend of chaos at the FDA is prompting questions around how much more the agency can take before its functionality is seriously impaired, Axios Vitals authors Caitlin Owens and Peter Sullivan write. Why it matters: The pharmaceutical and biotech industries depend on the agency being predictable and reliable to shepherd millions of dollars in investments. ? Zoom in: An agency is only as good as its workforce. After months of high-profile departures and open hostility from top health officials, some argue the FDA's performance is already deteriorating. Text messages from current FDA staffers shared confidentially with Axios show people disturbed by the turmoil and increasingly motivated to leave the agency — a threat heightened by the number of experienced career officials who've left. "If they could get enough money elsewhere, if they could get remote jobs, if they could get as much vacation, they would just leave," a former FDA staffer told Axios, speaking of current staffers. "I don't know that I've talked to anyone who's happy there." Keep reading.

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New FDA-approved glasses can slow nearsightedness in kids

WASHINGTON (AP) — For many children, the experience of getting their first pair of glasses is an inevitable milestone, the first in a lifetime of visits to the eye doctor.

https://apnews.com/article/essilor-stellest-glasses-myopia-nearsightedness-c1c04fd52a022860a5654b21e4f68179?

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? FDA hits "tipping point"

Illustration: Aïda Amer/Axios

Another abrupt departure of a high-ranking FDA official is raising alarm about a brain drain that could mean new drugs take longer to reach the public, Axios Vitals co-author Peter Sullivan writes. Why it matters: Biotech and pharmaceutical companies rely on the FDA for dependable guidance as they spend huge sums developing new treatments. The American public needs the agency to ensure treatments are safe and effective. ? Zoom in: The latest uproar surrounds the unexpected departure of Richard Pazdur, a respected oncologist who just three weeks ago became the fourth person to direct the FDA's drug center this year. Pazdur's appointment had helped calm nerves to some degree within industry. Now, executives are publicly questioning the agency's direction. John Crowley, CEO of the industry group the Biotechnology Innovation Organization, said the FDA is at a "tipping point." "This constant turmoil is undermining America's leadership in biotechnology, creating unprecedented regulatory instability and unpredictability, and risks ceding this critical sector to China."

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? FDA approves GLP-1 pill for weight loss

Illustration: Shoshana Gordon/Axios

The FDA approved a daily pill version of Novo Nordisk's blockbuster weight-loss drug Wegovy that'll be available in early January, Axios' Maya Goldman writes. "The pill is here," Novo Nordisk CEO Mike Doustdar said. Why it matters: The first oral GLP-1 drug approved for weight loss could provide a more convenient, cheaper alternative to injections. Pills are easier to manufacture, reducing the shortages that have plagued injectables. The Danish drugmaker said participants in a 64-week clinical trial saw an average weight loss of about 17% if they stayed on the daily pill, reduced their calorie intake and increased exercise. That's compared to 3% average weight loss among trial participants who received a placebo. The active ingredient in oral Wegovy will be manufactured in North Carolina. Read the announcement ...

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FDA asks for removal of suicide warnings on GLP-1 drugs

The Food and Drug Administration on Tuesday told Eli Lilly and Novo Nordisk to remove warnings about the risk of suicidal thoughts and behavior from the labels of their blockbuster GLP-1 weight-loss drugs.

https://www.axios.com/2026/01/13/fda-wegovy-zepbound-suicide-warnings?

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🍄 The FDA is fast-tracking its review of three companies working on psychedelic drugs for treating depression and other mental health conditions. Go deeper.

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New FDA analysis says US infant formula supply is safe after testing for potential contaminants

A new analysis of chemicals in U.S. infant formula found reassuringly low levels of heavy metals, pesticides and other potential contaminants, federal health officials said Wednesday.

https://apnews.com/article/infant-formula-heavy-metals-pesticide-42684eb7959346fe0479824344e81972?

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FDA announces its first OK of fruit-flavored e-cigarettes for adults in major shift under Trump

WASHINGTON (AP) — The Food and Drug Administration on Tuesday announced its first authorization of fruit-flavored electronic cigarettes intended for adult smokers, a major policy shift that comes after months of appeals to President Donald Trump from the vaping industry.

https://apnews.com/article/ecigarettes-fda-flavors-vaping-fruit-trump-ff2701ce00d797194666917beca43de6?