U.S. Food and Drug Administration
NOWDiagnostics Gets FDA Authorization for First At-Home Syphilis Test
The over-the-counter test gained marketing authorization amid a surge in syphilis and congenital syphilis cases nationwide. read more >
Drug Shortages Keep On Growing. Older, Injectable Medicines are Among the Most Vulnerable
Total active shortages hit an all-time high of 323 in this year’s first quarter, according to the University of Utah Drug Information Service. That’s up about 86% from a 10-year low of 174 last reached in 2017. read more >
by Associated Press -
FDA Advisers Urge Targeting JN.1 Strain in Recipe for Fall’s COVID Vaccines
Moderna, Pfizer and Novavax all said they could have supplies of JN.1-specific shots ready by fall, although they didn't provide amounts. read more >
by Associated Press -
Panel Rejects Psychedelic Drug MDMA as PTSD Treatment in Possible Setback for Advocates
They cited flawed study data, questionable research conduct and significant drug risks, including the potential for heart problems, injury and abuse. read more >
by Associated Press -
US Pledges Money and Other Aid to Help Track and Contain Bird Flu on Dairy Farms
The new funds include $101 million to continue work to prevent, test, track and treat animals and humans potentially affected by the virus. read more >
by Associated Press -
Many Cancer Drugs Remain Unproven 5 Years After Accelerated Approval, Study Finds
The U.S. Food and Drug Administration’s accelerated approval program is meant to give patients early access to promising drugs. But how often do these drugs actually improve or extend patients’ lives? read more >
by Associated Press -
ALS Drug Will Be Pulled From US Market After Study Showed Patients Didn’t Benefit
The medication is part of a string of drugs for deadly, degenerative diseases that have won FDA approval in recent years despite questionable evidence they work. read more >
by Associated Press -
FDA Advisers Vote Against Experimental ALS Treatment
The panel of Food and Drug Administration experts voted 17-1 that drugmaker Brainstorm's stem cell-based treatment has not been shown effective for patients with the fatal, muscle-wasting disease known as ALS. read more >
by Associated Press -
FDA Skeptical of Experimental ALS Treatment Pushed by Patient Advocates
In documents posted Monday, the FDA reiterated its longstanding position that drugmaker Brainstorm's lone study doesn't provide convincing evidence that its stem cell-based therapy helps patients with ALS, or amyotrophic lateral sclerosis. read more >
by Associated Press -
FDA Says It Needs More Research Before Deciding to Approve Nasal Spray to Treat Dangerous Allergies
The move comes four months after an FDA advisory committee recommended approval of the device, dubbed neffy. read more >
by Associated Press -
Popular Nasal Decongestant Doesn’t Actually Relieve Congestion, FDA Advisers Say
Advisers to the Food and Drug Administration voted unanimously on Tuesday against the effectiveness of the ingredient found in popular versions of Sud read more >
by Associated Press -
First Over-The-Counter Birth Control Pill Gets FDA Approval
The Food and Drug Administration cleared once-a-day Opill to be sold without a prescription, making it the first such medication to be moved out from behind the pharmacy counter. read more >
Alzheimer’s Drug Leqembi Gets Full FDA Approval
Japanese drugmaker Eisai received conditional approval from the FDA in January based on early results suggesting Leqembi worked by clearing a sticky brain plaque linked to the disease. read more >
by Associated Press -
First Gene Therapy for Deadly Form of Muscular Dystrophy Gets FDA Approval for Young Kids
The FDA OK'd the treatment only for children ages 4 and 5, based on study results showing the therapy helped produce a protein needed for muscle growth, which is missing in boys with the condition. read more >
by Associated Press -
New Nasal Spray to Reverse Fentanyl and Other Opioid Overdoses Gets FDA Approval
Opvee is similar to naloxone, the life-saving drug that has been used for decades to quickly counter overdoses of heroin, fentanyl and prescription painkillers. read more >
US Says Dogs Can Dine Al Fresco, but Not Everyone is On Board
Just in time for the summer dining season, the U.S. government has given its blessing to restaurants that want to allow pet dogs in their outdoor spaces. read more >
by Associated Press -
US Approves 1st Vaccine for RSV After Decades of Attempts
The move sets the stage for adults 60 and older to get vaccinated this fall — but first, the Centers for Disease Control and Prevention must decide if every senior really needs RSV protection or only those considered at high risk from the respiratory syncytial virus. read more >
by Associated Press -
What’s Behind Shortages of Adderall, Ozempic and Other Meds?
For some drugs, such as stimulants that treat ADHD, several factors fueled a shortage and make it hard to predict when it will end. read more >
by Associated Press -
Over-The-Counter Birth Control Pill Faces FDA Questions
The FDA cited problems with the reliability of some of the company's data on the drug, Opill, and questioned whether women with certain other medical conditions would correctly opt out of taking it. read more >
by Associated Press -
Powerful New Obesity Drug Poised to Upend Weight Loss Care
Tirzepatide, an Eli Lilly and Co. drug approved to treat type 2 diabetes under the brand name Mounjaro, helped people with the disease who were overweight or had obesity lose up to 16% of their body weight, or more than 34 pounds, over nearly 17 months, the company said on Thursday. read more >
by Associated Press -
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