FDA identified the recall of Avanos Medical Inc.’s artificial airway tube for children and infants as the most serious type, as its use could lead to serious injuries or death.
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The agency will require new safety warnings to be added in the prescribing information on labels for opioid pain relievers, including a warning about increased sensitivity to pain.
A California judge’s decision to allow expert testimony linking GSK’s heartburn drug Zantac to cancer wasn’t a surprise, analysts said, though the litigation will likely weigh on the drugmaker’s share price until a trial in the summer.
Altimmune released mid-stage data Tuesday showing pemvidutide helped reduce patients’ weight by 10%, but the company’s shares tumbled 55% over safety concerns with the obesity drug.
Coiled cable connecting the display and base on some devices of the company may fail, causing an unexpected shutdown, according to the FDA.
The drug failed to reduce the frequency or severity of hot flashes in post-menopausal women.
The company is now focused on analyzing the death and “consider potential next steps for development,” CEO Anna Protopapas said in a statement.
Lifesciences firms need to invest in technology that unifies data and workflows across medical information teams and safety teams. Integrating MI and safety helps them optimize the drug development lifecycle and ultimately drive greater patient safety.
The FDA said the silicon foam used in some reworked ventilator models may separate from plastic backing due to adhesive failure and can reduce the air flow as well as cause debris contamination. The issue can lead to patient injury or death.