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Amphastar Receives FDA Approval for Albuterol Sulfate Inhalation Aerosol
Morningstar· 8 hours ago(NASDAQ:AMPH) today announced that the U.S. Food and Drug Administration ("FDA") has granted approval for the Company's Abbreviated New Drug Application ("ANDA") for Albuterol ...
US FDA staff flags risk of low blood sugar for Novo Nordisk's weekly insulin
AOL· 4 hours agoThe company has proposed a label to suggest the use of continuous glucose monitoring devices for measuring blood sugar, among other measures, the FDA reviewers said. The staff ...
US FDA staff flags risk of low blood sugar for Novo Nordisk's weekly insulin
Reuters via Yahoo News· 4 hours ago(Reuters) -The U.S. Food and Drug Administration's staff said on Wednesday the use of Novo Nordisk's...
Roche’s Tina-quant Lp(a) test receives FDA breakthrough device designation
Medical Device Network via Yahoo Finance· 8 hours agoRoche has received the US Food and Drug Administration’s (FDA) breakthrough device designation for...
It’s Official: Tara Flour Is an Unapproved Food Additive, According to the FDA
Eating Well via Yahoo News· 21 hours agoTara flour made headlines in 2022 after hundreds got sick from Daily Harvest crumbles. Now the FDA...
FDA said it never inspected dental lab that made controversial AGGA device
San Jose Mercury News· 5 days agoThe FDA never inspected Johns Dental Laboratories during more than a decade in which it made the...
US FDA staff says Guardant's test may fail to detect some pre-cancerous tumors
Reuters via Yahoo News· 1 day agoThe reviewers, however, said the test may increase compliance with screening for colorectal cancer...
LDTs: FDA Rolls Out a Phased Implementation for New Regulatory Requirements | JD Supra
JD Supra· 1 day agoOn May 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final rule significantly modifying FDA’s approach to oversight of laboratory developed ...
FDA approves Imdelltra for patients with extensive-stage small cell lung cancer
United Press International via Yahoo News· 5 days agoImportantly, tarlatamab (Imdelltra) is only for patients who have exhausted all other options to...
Democrats urge DOJ to rescind Trump-era opinion on execution drugs
The Hill via AOL· 1 hour agoA group of Democratic senators on Tuesday called on the Department of Justice (DOJ) to rescind a...