Iterum Therapeutics Gets FDA Approval Of Orlynvah

As FDA probes source of national E. coli outbreak, California firm recalls onion products
Salinas-based international food production giant Taylor Farms had announced a recall on four onion products 'due to ...
Managed Healthcare Executive5h
FDA Approves IV Form of Stelara Biosimilar Selardsi
This week’s approval expands Seldardsi indications to treat adults with Crohn’s disease and ulcerative colitis.
FiercePharma12h
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 ...
dvm36011h
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 ...
TCTMD11h
Michelle Tarver Named New FDA Director of Medical Devices
Tarver, an ophthalmologist, replaces longtime CDRH Director Jeff Shuren, who announced his retirement in July.
JD Supra12h
FDA Finalizes Guidance on Use of Part 11 Electronic Systems, Records and Signatures in Clinical Investigations
On October 1, 2024, the US Food and Drug Administration (FDA) finalized its guidance on the use of electronic records in clinical investigations ...
MrBeast's Lunchly Meal Brand Reportedly Hit By FDA Complaints, Claims of Mold
The brand was launched last month by Logan Paul, KSI, and MrBeast.
FierceBiotech15h
FDA approves Medtronic’s Affera all-in-one pulsed field ablation system
Less than a year after obtaining an FDA approval for its first foray into pulsed field ablation, Medtronic has done it again.