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Healthcare Dive
1 天
5 steps to navigate the FDA’s new lab developed test rule
Laboratories face a series of upcoming deadlines to comply with stricter FDA oversight of in-house tests. Here are five ...
infectiousdiseaseadvisor.com
1 天
Flublok Labeling Updated With New Safety Data for Pregnant Individuals
The FDA has approved updated labeling for Flublok (influenza vaccine) to include new safety data involving pregnant individuals.
dvm360
4 天
FDA: Off-label use of aspirin in lactating dairy cattle is prohibited
Vazalore is currently the only FDA-approved human aspirin that may be used in food-producing animals under certain conditions ...
5 天
on MSN
Your supplements might not contain what's on the label. The US's leading expert shared 3 ...
Dietary supplements aren't FDA-approved like drugs. The director of the Office of Dietary Supplements offered advice ...
Zacks.com on MSN
11 天
Avadel Obtains FDA Nod for Label Expansion of Narcolepsy Drug Lumryz
Avadel Pharmaceuticals plc AVDL announced that the FDA has approved its supplemental new drug application (sNDA) seeking ...
13 天
FDA Updates Sanofi's FLUBLOK Vaccine Label With New Safety Data For Pregnant Individuals
Sanofi (SNYNF, SNY) said that the U.S. Food and Drug Administration has updated the label for FLUBLOK (Influenza Vaccine) to include ...
FiercePharma
12 天
Novartis falls short in legal effort to undo FDA approval of MSN's Entresto generic
As a host of generics circle the gates, Novartis has lost another bid to waylay MSN Pharmaceuticals’ copycat of the Swiss ...
FiercePharma
4 天
After prior rejection, Iterum nabs long-sought FDA nod for oral UTI drug Orlynvah
Despite recent concerns from the FDA about potential off-label use and antimicrobial resistance, Dublin-based Iterum ...
4 天
Iterum Therapeutics announces FDA approval of Orlynvah
Iterum Therapeutics (ITRM) plc announced that the U.S. Food and Drug Administration has approved Iterum’s new drug application for ...
MassDevice
7 天
iRhythm stock soars on FDA nod for changes to Zio AT following warning letter
Rhythm Technologies (Nasdaq:IRTC) announced today that it received FDA 510(k) clearance related to design changes made to its ...
6 天
FDA approves Vyalev for advanced Parkinson's disease
The U.S. Food and Drug Administration has approved AbbVie's Vyalev (foscarbidopa and foslevodopa) for adults living with ...
Diabetes.co.uk
1 天
Caution urged for off-label glucose-lowering drugs in type 1 diabetes
Off-label SGLT2 inhibitors increase the risk of euglycemic diabetic ketoacidosis. GLP-1RAs may lead to rapid weight loss in ...
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