Pharmaceutical Technology23m
FDA issues CRL to Astellas’ IZERVAY sNDA for geographic atrophy
The US FDA has issued a CRL for sNDA of Astellas Pharma’s IZERVAY, a treatment for geographic atrophy (GA) secondary to AMD.
'May be unsafe': Cinnamon powder voluntarily recalled for elevated lead levels, FDA says
The brand for the Super Cinnamon Powder is Super Brand. Super Brand, which is distributed by IHA Beverage, ...
Fierce Healthcare13h
FDA advisory committee to roll up sleeves on generative AI this week
The Food and Drug Administration will hold its first Digital Health Advisory Committee (DHAC) meeting to discuss how the ...
STAT22h
The FDA’s risky action on compounding weight loss drugs
The FDA’s decision to allow the compounding of GLP-1 weight loss drugs could undermine its public health obligations, writes ...
Yahoo14h
FDA shares additional draft guidance on CGTs
Credit: Anusorn Nakdee / Shutterstock. The US Food and Drug Administration (FDA) has published new draft guidance around ...
Dietary Supplement Recall Update As FDA Sets Risk Level
A Vitamin B supplement has been recalled due to being incorrectly formulated with niacin rather than niacinamide.
STAT22h
In first meeting of FDA’s digital health advisory committee, generative AI is up for debate
The FDA's digital health advisory committee is expected to weigh in on how generative AI should be regulated by the agency.
Yahoo9h
FDA finds bacteria, ‘black mold-like substance’ while inspecting Tom’s of Maine facility
According to the letter, dated Nov. 5, the FDA inspected the Tom’s of Maine facility between May 7 and May 22, 2024. During ...
dvm36010h
First generic propofol injectable emulsion for dogs receives FDA approval
PropofolVet Multidose contains the same active ingredient as the brand name propofol injectable emulsion, PropoFlo 28 by ...