States, Tribes to Have Easier Time Importing Drugs From Canada
Prescription Drugs
States, Tribes to Have Easier Time Importing Drugs From Canada
2025-05-21 21:19:14
by Dan McCue

WASHINGTON — The Food and Drug Administration on Wednesday announced “enhancements” under section 804 of the Federal Food, Drug and Cosmetic Act to allow states and Indian tribes to more easily import certain prescription drugs from Canada. The move, implementing... Read More

FDA Seeking Expanded Warning Labels for COVID-19 Vaccines
Regulation
FDA Seeking Expanded Warning Labels for COVID-19 Vaccines
2025-05-21 20:43:05
by Dan McCue

WASHINGTON — The Food and Drug Administration has directed Pfizer and Moderna to expand warning labels on their COVID-19 vaccines to include risks of a heart injury side effect associated with the mRNA shots. According to letters to Pfizer (and... Read More

President Seeks to Speed Approval of New Pharma Manufacturing Plants
Manufacturing
President Seeks to Speed Approval of New Pharma Manufacturing Plants
2025-05-06 17:19:27
by Dan McCue

WASHINGTON — President Donald Trump signed an executive order Monday aimed at reducing the time it takes the Food and Drug Administration and other agencies to approve the construction of new pharmaceutical plants in the country. The order comes as... Read More

FDA to Phase Out Petroleum-Based Dyes in Foods
Food
FDA to Phase Out Petroleum-Based Dyes in Foods
2025-04-22 21:40:48
by Dan McCue

WASHINGTON — The Food and Drug Administration announced Tuesday that it plans to end the use of petroleum-based synthetic food dyes in America’s food supply within the next two years in a bid to combat a myriad of health concerns,... Read More

HHS, FDA Unveil ‘Operation Stork Speed’ to Expand Access to Infant Formula
In The News
HHS, FDA Unveil ‘Operation Stork Speed’ to Expand Access to Infant Formula
2025-03-19 20:13:25
by Dan McCue

WASHINGTON — The Trump administration is launching a renewed effort to ensure the “ongoing quality, safety, nutritional adequacy and resilience” of the infant formula supply in the United States. The initiative, dubbed “Operation Stork Speed,” is a collaborative effort between... Read More

Kennedy to FDA: Take Second Look at Food Ingredients
Health
Kennedy to FDA: Take Second Look at Food Ingredients
2025-03-14 17:37:54
by Dan McCue

WASHINGTON — Health and Human Services Secretary Robert F. Kennedy Jr. directed the Food and Drug Administration this week to begin the process of eliminating chemicals “generally regarded as safe” from the nation’s foods. In a video posted to the... Read More

Food and Drug Administration to Delay ‘Healthy’ Food Label
Regulation
Food and Drug Administration to Delay ‘Healthy’ Food Label
2025-02-24 21:42:54
by Dan McCue

WASHINGTON — Two months after finalizing a rule updating the nutritional requirements foods must meet to be labeled “healthy,” the Food and Drug Administration is pushing back its effective date. The final rule was to have gone into effect on... Read More

Health Warning Issued for Braga Fresh Broccoli Florets
Health
Health Warning Issued for Braga Fresh Broccoli Florets
2025-01-02 16:33:50
by Dan McCue

SOLEDAD, Calif. — A voluntary recall of certain broccoli florets has been issued as a precaution due to the possibility of a shipment of the vegetables being contaminated with Listeria monocytogenes. The recall was issued by Braga Fresh for its... Read More

FDA Approves Dupixent as First Biologic Treatment for COPD
Health
FDA Approves Dupixent as First Biologic Treatment for COPD
2024-10-03 20:04:35
by Dan McCue

WASHINGTON — The Food and Drug Administration has approved Dupixent (dupilumab) as the first biologic treatment for patients with uncontrolled chronic obstructive pulmonary disease and an eosinophilic phenotype. The agency approval, which was announced last week, was based on clinical... Read More

Golden Raisins Recalled Due to Absence of Sulfite Warning
Food
Golden Raisins Recalled Due to Absence of Sulfite Warning
2024-09-11 15:39:48
by Dan McCue

WASHINGTON — Sunco & Frenchie LCC, the Pine Brook, New Jersey, food manufacturer, is recalling batches of its Terrafina brand Golden Raisins because they may contain undeclared sulfites, the Food and Drug Administration has announced. People who have an allergy... Read More

FDA Increases Minimum Age for Restrictions on Tobacco Sales
Regulation
FDA Increases Minimum Age for Restrictions on Tobacco Sales
2024-08-29 16:02:58
by Dan McCue

WASHINGTON — The Food and Drug Administration on Thursday said it is raising the minimum age for certain restrictions on the sale of tobacco products. The new rule, which will be published in the Federal Register on Friday, states that... Read More

FDA Approves First Nasal Epinephrine Spray for Allergic Reactions
In The News
FDA Approves First Nasal Epinephrine Spray for Allergic Reactions
2024-08-09 17:06:10
by Dan McCue

WASHINGTON — The Food and Drug Administration on Friday approved ARS Pharmaceuticals’ neffy epinephrine nasal spray for the emergency treatment of allergic reactions, including those that result in life-threatening anaphylaxis. Neffy is a single-dose nasal spray administered into one nostril.... Read More

FDA Believed Poised to Approve First Med for a Serious Liver Disease
Regulation
FDA Believed Poised to Approve First Med for a Serious Liver Disease
2024-03-13 16:49:07
by Dan McCue

WASHINGTON — The Food and Drug Administration appears poised to approve the first medicine developed specifically to treat the serious liver disease known as MASH later this week.  Metabolic dysfunction-associated steatohepatitis -- formerly known as nonalcoholic steatohepatitis — is often... Read More

FDA Unveils New Regulation Portal for Food Program
Regulation
FDA Unveils New Regulation Portal for Food Program
2024-01-29 17:52:05
by Dan McCue

WASHINGTON — The Food and Drug Administration has unveiled a new website detailing the Foods Program regulations it plans to publish through October 2024. The web portal, which will also list longer-term regulations the agency is prioritizing for publication at... Read More

FDA Approves First Therapy for Rare Type of Non-Cancerous Tumors
Health
FDA Approves First Therapy for Rare Type of Non-Cancerous Tumors
2023-11-28 15:54:36
by Dan McCue

WASHINGTON — The Food and Drug Administration on Tuesday approved Ogsiveo tablets for adult patients with progressing desmoid tumors, a rare subtype of soft tissue sarcomas. Desmoid tumors are non-cancerous but can be locally aggressive, invading surrounding structures and organs,... Read More

FDA Approves Biosimilar for Treatment of Multiple Inflammatory Diseases
Prescription Drugs
FDA Approves Biosimilar for Treatment of Multiple Inflammatory Diseases
2023-11-01 18:27:47
by Dan McCue

WASHINGTON — The Food and Drug Administration on Tuesday approved Wezlana, a biosimilar interchangeable with Stelara for the treatment of multiple inflammatory diseases. The agency said its approval of Wezlana, which is manufactured by Amgen, was based on a comprehensive... Read More

Eyedrops From CVS, Rite Aid and Others Carry Possible Infection Risk, FDA Says
Health
Eyedrops From CVS, Rite Aid and Others Carry Possible Infection Risk, FDA Says

WASHINGTON (AP) — U.S. health regulators are warning consumers not to use more than two dozen varieties of over-the-counter eyedrops because of the risk of infections that could lead to blindness. The Food and Drug Administration advisory applies to lubricating drops sold... Read More

FDA Authorizes Updated Novavax COVID-19 Vaccine 
Health
FDA Authorizes Updated Novavax COVID-19 Vaccine 
2023-10-03 20:09:18
by Dan McCue

WASHINGTON — The Food and Drug Administration on Tuesday amended its emergency use authorization for the Novavax COVID-19 vaccine, approving an updated version of the vaccine for use by previously vaccinated individuals aged 12 and older. Of course, those who... Read More

FDA Approves Marketing of DNA Test for Cancer Predisposition
Health
FDA Approves Marketing of DNA Test for Cancer Predisposition
2023-10-03 20:02:44
by Dan McCue

WASHINGTON — The Food and Drug Administration has granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test that can help detect hundreds of genetic variants associated with an elevated risk of developing... Read More

How a Government Shutdown Would Affect Federal Health Programs
Health
How a Government Shutdown Would Affect Federal Health Programs
2023-09-27 18:02:15
by Dan McCue

WASHINGTON — With uncertainty continuing to swirl around Capitol Hill, conversations have begun to focus not on if there will be a partial shutdown of the federal government come midnight on Saturday, but on how that almost inevitable shutdown will... Read More

FDA Skeptical of Experimental ALS Treatment Pushed by Patient Advocates
Health
FDA Skeptical of Experimental ALS Treatment Pushed by Patient Advocates

WASHINGTON (AP) — The Food and Drug Administration meets this week to consider approval of an experimental treatment for Lou Gehrig’s disease, the culmination of a yearslong lobbying effort by patients with the fatal neurodegenerative disease. Those advocates still face one giant... Read More

FDA Approves Updated COVID Vaccines for New Variants 
Health
FDA Approves Updated COVID Vaccines for New Variants 
2023-09-11 19:35:37
by Dan McCue

WASHINGTON — The Food and Drug Administration on Monday approved the use of updated COVID-19 vaccines to provide the public with additional protection against the virus ahead of a potential winter bump in cases. One thing the FDA did not... Read More

FDA Approves First Oral Treatment for Postpartum Depression
Women's Issues
FDA Approves First Oral Treatment for Postpartum Depression
2023-08-07 17:08:33
by Dan McCue

WASHINGTON — The U.S. Food and Drug Administration has given its approval of the first oral medication to treat postpartum depression, a condition that is believed to impact one in seven women during the latter stages of pregnancy and after... Read More

FDA Approves First Drug to Slow Alzheimer’s Progression
Health
FDA Approves First Drug to Slow Alzheimer's Progression
2023-07-07 20:56:22
by Dan McCue

WASHINGTON — The Food and Drug Administration on Thursday gave its first approval to a drug that can slow the progression of Alzheimer's disease. In a press release the agency said its full approval of lecanemab, known by the brand... Read More

FDA Releases Draft Guidance for Tattoo Ink Safety
Health
FDA Releases Draft Guidance for Tattoo Ink Safety
2023-06-15 15:14:40
by Carter Schaffer

WASHINGTON — The Food and Drug Administration on Monday released draft recommendations for tattoo ink manufacturers and distributors aimed at reducing the potential harm caused by microbial contamination. The guidance includes examples of unsanitary manufacturing and distributing conditions and provides... Read More

Health Leaders Urge More Be Done to Prevent Overdose Deaths
Drugs
Health Leaders Urge More Be Done to Prevent Overdose Deaths
2023-06-13 18:41:04
by Dan McCue

WASHINGTON — Top officials at the National Institutes of Health and the Food and Drug Administration are urging that more be done to advance the development of rapid drug-testing tools to stem the rising tide of overdose deaths in the... Read More

FDA Proposes New, Easy-to-Read Medication Guide for Patients
Prescription Drugs
FDA Proposes New, Easy-to-Read Medication Guide for Patients
2023-05-31 17:36:11
by Dan McCue

WASHINGTON — The Food and Drug Administration wants to make it easier for patients to understand why they’ve been prescribed specific medications and how to ensure they don’t suffer any preventable adverse reactions when taking them. Toward that end the... Read More

Fourth Death Attributed to Recalled Artificial Tears
Health
Fourth Death Attributed to Recalled Artificial Tears
2023-05-24 21:03:25
by Dan McCue

ATLANTA — A fourth death has been linked to a recalled brand of artificial tears made by EzriCare and Delsam Pharma, as the number of infections with a highly drug-resistant bacteria grew to 81 across 18 states, the Centers for... Read More

FDA Approves First Vaccine for Highly Contagious Lung Infection
Health
FDA Approves First Vaccine for Highly Contagious Lung Infection
2023-05-03 18:24:39
by Dan McCue

WASHINGTON — The Food and Drug Administration on Wednesday licensed the first-ever vaccine for respiratory syncytial virus, or RSV, a highly contagious virus that is a common cause of lower respiratory tract disease in older adults. The vaccine, Arexvy, was... Read More

FDA Conditionally Approves First Drug for Anemia in Cats
Regulation
FDA Conditionally Approves First Drug for Anemia in Cats
2023-05-01 21:28:01
by Dan McCue

WASHINGTON — The Food and Drug Administration on Monday conditionally approved Varenzin-CA1, the first drug for the control of nonregenerative anemia associated with chronic kidney disease in cats.  Nonregenerative anemia is a potentially fatal condition in which a cat’s bone... Read More

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