The Food and Drug Administration

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FDA Approves New Treatment for Stroke

March 4, 2025 -- The FDA has approved the first new clot-busting drug in nearly 30 years, offering a faster way to dissolve blood clots in adults who suffer a stroke.

https://www.webmd.com/stroke/news/20250304/fda-approves-tnkase-treatment-stroke?

 

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FDA OKs Nasal Spray for Severe Allergic Reactions in Kids

March 6, 2025 – The FDA has approved a new nose spray that can quickly treat severe allergic reactions in kids ages 4 and up. This is the first emergency treatment that doesn’t use a needle. The spray, called Neffy, delivers medicine in one quick puff into the nose, making it easy to use.

https://www.webmd.com/allergies/news/20250306/fda-oks-neffy-spray-allergies-kids?

FDA OKs First Myasthenia Gravis Treatment for Children

March 11, 2025 -- The FDA has approved a new treatment for children with generalized myasthenia gravis (gMG), a disease that makes muscles weak and tired quickly. This is the first and only medicine for children 6 and older with gMG who have certain antibodies linked to the condition.

https://www.webmd.com/brain/news/20250311/fda-oks-first-myasthenia-gravis-treatment-children?

FDA OKs First Gene Therapy Implant for a Rare Eye Disease

March 7, 2025 – The FDA has approved a new gene therapy for macular telangiectasia type 2 (MacTel), a rare  eye disease that causes vision loss. The approval marks the first and only implantable therapy that uses cell technology to deliver a protein that helps slow the disease’s progression.

https://www.webmd.com/eye-health/news/20250307/fda-oks-first-gene-therapy-implant-for-a-rare-eye-disease?

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Why is Donald Trump crashing the US economy? Because he’s high on his own supply of fake news | Jonathan Freedland

Not content with shattering the post-1945 international order, which delivered prosperity and power to his country for eight long decades, Donald Trump is seemingly set on destroying the US economy. And he’s doing it because he, and the American right, have lost their ability to grasp reality.

https://www.newsbreak.com/the-guardian-560688/3856098831814-why-is-donald-trump-crashing-the-us-economy-because-he-s-high-on-his-own-supply-of-fake-news-jonathan-freedland

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The FDA Finally Visited an Indian Drug Factory Linked to U.S. Deaths. It Found Problems.

The inspection comes after a ProPublica investigation revealed that drugs made at the Glenmark Pharmaceuticals plant accounted for an outsized share of U.S. recalls for pills that didn’t dissolve properly and could harm people.

https://www.propublica.org/article/glenmark-pharmaceuticals-recalls-fda-inspection?

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Debate over the abortion pill mifepristone resurfaces after Makary is confirmed to head the FDA

In recent testimony before the Senate health committee, President Donald Trump’s pick to lead the Food and Drug Administration wouldn’t commit to specific action on the pill, called mifepristone, despite prodding from both Republicans and Democrats. Read More.

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Top vaccine official resigns from FDA, criticizes RFK Jr. for promoting ‘misinformation and lies’

WASHINGTON (AP) — The top vaccine official with the Food and Drug Administration has resigned and criticized the nation’s top health official for allowing “misinformation and lies” to guide his thinking behind the safety of vaccinations.

https://apnews.com/article/fda-vaccine-chief-peter-marks-resign-rfk-kennedy-7743be11cec4e4e22c50c2ddbcb6bcd8?

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FDA OKs Drug for Insatiable Hunger in Prader-Willi Syndrome

March 27, 2025 – The FDA has approved a drug to treat a key symptom of a rare life-threatening genetic disorder known as Prader-Willi syndrome (PWS) in adults and children ages 4 or older. It marks the first treatment for an extreme, uncontrollable urge to eat, also known as hyperphagia.

https://www.webmd.com/children/news/20250327/fda-oks-drug-for-insatiable-hunger-in-prader-willi-syndrome?

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Resistant remedy

Effective treatments for gonorrhea have been difficult to find due to antimicrobial resistance — until now. A new type of antibiotic for urinary tract infections, called gepotidacin, may also work against the sexually transmitted infection.

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FDA Issues Warning About Counterfeit Ozempic

April 14, 2025 — The FDA and the maker of the popular diabetes and weight loss drug Ozempic are warning people not to use counterfeit semaglutide 1.0 milligrams — the Ozempic injection — found in the U.S. drug supply chain. 

https://www.webmd.com/obesity/news/20250414/fda-issues-warning-counterfeit-ozempic?

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FDA Approves Dupixent for Chronic Skin Condition

April 21, 2025 – The FDA just approved the popular drug Dupixent for adults and kids 12 and up with chronic spontaneous urticaria (CSU), a long-lasting itchy skin condition, when regular allergy meds don't do the trick.

https://www.webmd.com/skin-problems-and-treatments/news/20250421/fda-approves-dupixent-for-chronic-skin-condition?

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FDA OKs New Drug for Rare Head and Neck Cancer

April 25, 2025 — The FDA has approved a new drug for adults with a rare type of head and neck cancer known as non-keratinizing nasopharyngeal carcinoma (NPC) after studies showed that patients treated with the drug lived longer without their cancer worsening than with standard treatments.

https://www.webmd.com/cancer/news/20250425/fda-oks-new-drug-nasopharyngeal-cancer?

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The First Drug of Its Kind

https://www.webmd.com/eye-health/macular-degeneration/video/ga-innovations?

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Critic of drug industry and COVID-19 measures to lead FDA vaccine program

Dr. Vinay Prasad, a prominent critic of the pharmaceutical industry and the Food and Drug Administration, has been named to oversee the health agency’s program for vaccines and biotech drugs. Read More.

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FDA Approves New Long-Term Treatment for Myasthenia Gravis

May 2, 2025 -- The FDA has approved a new treatment for generalized myasthenia gravis (gMG), a disease that causes severe muscle weakness, faster muscle fatigue, and difficulty in speaking and swallowing. It offers long-lasting option for symptom relief to about 100,000 patients living with the disorder in the United States.

https://www.webmd.com/brain/news/20250502/fda-approves-new-treatment-myasthenia-gravis?

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Talk to the hand. In response to a journalist’s queries regarding the FDA’s proposed rule on nutrition labels on Feb. 7, a health department communications director told the FDA’s communications team, “Let’s ignore this request please.” And in a separate request for information on vaccines for RSV, a respiratory illness that’s the leading cause of infant hospitalizations, officials told an FDA communications officer to remove part of its standard response stating the agency believes the benefits of the vaccines outweigh their risks.

• In March, a reporter from Vox requested information about the FDA’s vaccine monitoring program. A health department press secretary responded with this: “The decision to vaccinate is a personal one. People should consult with their healthcare provider to understand their options to get a vaccine and should be informed about the potential adverse events associated with vaccines.” 

A costly edit. Such responses aren’t just a matter of shifting messaging. Insiders say the obfuscation risks jeopardizing the FDA’s mission of protecting the public’s health. HHS “started taking a heavy hand on editing our responses,” after Kennedy assumed command of the agency, said former press officer Chanapa Tantibanchachai, who was laid off in April. Another fired press officer, who asked to remain anonymous, noted that the media team was “muzzled on information that needed to go out to the public… There’s information that’s not going to get out there that could save lives.” 

Brain drain. Kennedy’s crackdown is already forcing defections within the FDA: The agency’s longtime top internal auditor resigned this week from a 30-year career after reportedly telling colleagues he was “miserable” under Kennedy’s tenure. And last week, a top vaccine adviser to the FDA said he was forced out of the agency because “truth and transparency are not desired” by the new administration. 

Reporting contributed by Helen Santoro and Jeanne Lenzer.

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FDA will allow three new color additives made from minerals, algae and flower petals

U.S. regulators said Friday that they would allow three new color additives made from natural sources to be used in the nation's food supply. Read More.

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RFK Jr.’s Vow Of Silence. Health and Human Services Secretary Robert F. Kennedy Jr. is ushering in a new era of secrecy at the FDA.

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First at-home test kit for cervical cancer approved by the FDA, company says

WASHINGTON (AP) — 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.

https://apnews.com/article/hpv-test-home-cervical-cancer-fda-2ebb9d757add4cdad03809f589506c53?

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FDA and RFK Jr. aim to remove fluoride supplements used to protect kids’ teeth

U.S. health regulators announced plans Tuesday to phase out fluoride-containing supplements sometimes used to strengthen children’s teeth, opening a new front in Health Secretary Robert F. Kennedy Jr.’s effort against a mainstay of dental care. The FDA said it will conduct a scientific review of the products with the aim of removing them from the market. Read More.

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FDA Approves New Oral Drug Combo for Rare Ovarian Cancer

May 9, 2025 -- A new oral cancer drug combination has gained a quick federal nod after clinical trials found that it provides significant and longer-lasting relief for a rare ovarian cancer that doesn’t respond well to standard therapies. This marks the first and only FDA-approved medicine for low-grade serous ovarian cancer (LGSOC) that tests positive for a gene change known as the KRAS mutation.

https://www.webmd.com/ovarian-cancer/news/20250509/fda-approves-new-oral-drug-combo-rare-ovarian-cancer?

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Vaccine shift

The US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans — a move that will limit future shots to seniors and others at higher risk. Millions of healthy adults and kids will likely lose access under the new criteria.

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FDA OKs Nucala for Hard-to-Treat COPD

May 23, 2025 -- The FDA has approved the asthma drug Nucala for adults with chronic obstructive pulmonary disease (COPD). It is the second biologic therapy approved for the condition, following the approval of Dupixent for COPD in September. 

https://www.webmd.com/lung/copd/news/20250523/fda-oks-nucala-hard-treat-copd?

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FDA Approves New Treatment for Dry Eye Disease

May 30, 2025 -- The FDA has approved a new treatment for dry eye disease (DED) after studies showed it can help stimulate natural tear production as early as the first day of use.

https://www.webmd.com/eye-health/news/20250530/fda-approves-new-treatment-dry-eye-disease?

FDA OKs Nucala for Hard-to-Treat COPD

May 23, 2025 -- The FDA has approved the asthma drug Nucala for adults with chronic obstructive pulmonary disease (COPD). It is the second biologic therapy approved for the condition, following the approval of Dupixent for COPD in September. 

https://www.webmd.com/lung/copd/news/20250523/fda-oks-nucala-hard-treat-copd?

FDA OKs New Treatment for Hard-to-Treat Lung Cancer

May 16, 2025 – The FDA has granted fast-track approval to a first-of-its-kind treatment for a type of advanced lung cancer. 

https://www.webmd.com/lung-cancer/news/20250516/fda-oks-new-treatment-for-hard-to-treat-lung-cancer?

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FDA Approved — And Ineffective

Federal regulators have authorized hundreds of drugs without evidence they work, and many are dangerous.

https://www.levernews.com/fda-approved-and-ineffective/?

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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?