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 >
The move comes four months after an FDA advisory committee recommended approval of the device, dubbed neffy. read more >
Advisers to the Food and Drug Administration voted unanimously on Tuesday against the effectiveness of the ingredient found in popular versions of Sudafed, Allegra, Dayquil and other medications stocked on store shelves. read more >
Scientists say while these drugs may mark a new era in Alzheimer's therapy, huge questions remain about which patients should try them and how much benefit they'll really notice. read more >
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 >
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 >
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 >
Today's vaccines still contain the original coronavirus strain, the one that started the pandemic — even though that was long ago supplanted by mutated versions as the virus rapidly evolves. read more >
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 >
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 >
The panel of FDA advisers voted unanimously in favor of drugmaker Perrigo's request to sell its once-a-day medication on store shelves alongside eye drops and allergy pills. read more >
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 >
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 >
It's the first drug for an inherited form of ALS, or amyotrophic lateral sclerosis, a deadly disease that destroys nerve cells needed for basic functions like walking, talking and swallowing. read more >
The justices granted emergency requests from the Biden administration and New York-based Danco Laboratories, maker of the drug mifepristone. They are appealing a lower court ruling that would roll back Food and Drug Administration approval of mifepristone. read more >
The court finds itself immersed in a new fight involving abortion less than a year after conservative justices reversed Roe v. Wade and allowed more than a dozen states to effectively ban abortion outright. read more >
The decision follows repeated efforts by Swiss drugmaker Covis Pharma to keep Makena on the U.S. market while it conducted additional studies. read more >
One in five Medicare recipients currently uses medical marijuana. read more >
The drugstore chain says it will not start selling an abortion pill in 20 states that had warned of legal consequences if it did so. read more >
The positive vote, which is not binding, came despite concerns from some panel members about the drug's instructions and packaging. read more >
