The Class I recall affects nearly 250,000 devices.

​​​​​​​The FDA has approved Provention’s BLA for intravenous antibody TZIELD to delay stage 3 type 1 diabetes, making it the first disease-modifying drug indicated to slow disease progression.

After examining the available information and hearing the testimony of CKD patients who participated in the clinical studies, the majority of the committee agreed the benefits of the medication outweighed its risks as a monotherapy.

​​​​​​​The FDA has requested that Clovis Oncology limit the indication of its PARP inhibitor Rubraca as second-line maintenance therapy in recurrent ovarian cancer.

Yesterday the U.S. health regulator issued an emergency use authorization to Roche’s test for the detection of DNA from monkeypox virus in swab specimens collected from people suspected of the virus infection.

Opioid overdose reversal drug naloxone may be safe and effective for over-the-counter use in some forms, the U.S. Food and Drug Administration said on Tuesday, potentially paving the way for its use federally.

Using a special desktop camera, AEYE takes images from each eye and through artificial intelligence it captures and analyzes data of the retina that helps diagnose diseases, including diabetes, that could lead to blindness.

ImmunoGen’s Elahere was approved Monday under the FDA’s accelerated pathway for patients who have received one to three previous lines of systemic therapy.

FDA staff reviewers raised concerns over unclear benefits of Ardelyx Inc.’s drug for kidney disease patients, stating, “the magnitude of treatment effect appears less than that observed with approved drugs,” in briefing documents released on Monday.

The company reported Onivyde and 5 fluorouracil/leucovorin and oxaliplatin demonstrated a statistically significant improvement in overall survival compared to nab-paclitaxel plus gemcitabine regimen. The study also met its key secondary endpoint of progression-free survival.