Findings from a ‘human factors’ study indicate that reprocessing instructions for duodenoscopes in current user manuals are hard for staff to follow. News Alerts
The prescription-only reSET-O application is intended for use in conjunction with outpatient therapy to treat opioid use disorder. FDA Approvals
The immunotherapy has received FDA approval for an expanded indication for use in combination in nonsmall cell lung cancer. News Alerts
The 2018 medical specialties match set record highs in number of applicants, programs, positions, and positions filled for 2019. Medscape Medical News
The latest recall stems from NDEA contamination and includes 26 lots of amlodipine/valsartan tablets, 51 lots of valsartan tablets, and 27 lots of valsartan/hydrochlorothiazide tablets. News Alerts
The FDA has expanded the label for the gammaCore vagus nerve stimulator to include adjunctive use in the prevention of cluster headache in adults. FDA Approvals
Dextenza is the first FDA-approved intracanalicular insert that delivers dexamethasone to treat ocular pain following ophthalmic surgery for up to 30 days with a single insertion. FDA Approvals
The Alethia CMV Assay Test System detects the DNA of CMV in the saliva of newborns and should only be used in conjunction with the results of other diagnostic tests and clinical information. FDA Approvals
Pifeltro contains doravirine, a new nonnucleoside reverse transcriptase inhibitor, and Delstrigo is a fixed-dose combination of doravirine, lamivudine, and tenofovir disoproxil fumarate. International Approvals
Amifampridine (Firdapse) is approved for adults with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder characterized by muscle weakness. FDA Approvals
A life-threatening side effect called differentiation syndrome is not being recognized in patients receiving the acute myeloid leukemia drug enasidenib, says the FDA. News Alerts
A life-threatening adverse effect called differentiation syndrome is not being recognized in patients receiving the acute myeloid leukemia drug enasidenib, says the FDA. News Alerts
The FDA’s approval is for the first drug targeting FLT3 mutations in AML. FDA Approvals
Truxima, designed for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin lymphoma, can be used as a single agent or in combination with chemotherapy. FDA Approvals
A software defect in the BrightMatter Guide system could result in serious or life-threatening harm, prompting the company to issue a recall. The FDA has labeled it a Class I recall, the most serious type. News Alerts
In the ongoing saga of tainted sartans, Teva recalls all amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide combination products because of contamination with NDEA. News Alerts
International Approvals
FDA scientists have found heavy metals including lead and nickel at levels not considered safe for human consumption in some kratom products. News Alerts
Larotrectinib targets a key genetic driver that occurs in multiple types of cancer, rather than a specific tumor type. FDA Approvals
Pfizer’s Daurismo Improves Overall Survival in Newly Diagnosed Patients Aged 75+ FDA Approvals
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