Tag Archive for: FDA

Ascendis Pharma A/S said on Monday the U.S. Food & Drug Administration had declined to approve the Danish drugmaker’s experimental therapy to treat adult patients with a hormone disorder called hypoparathyroidism, citing concerns linked to manufacturing control of the drug and device combination.

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.

Polivy is approved for front-line DLBCL as part of a combination regimen including Rituxan, cyclophosphamide, doxorubicin and prednisone.

Today the company clarified that 2.2 million devices it has repaired or replaced in a major recall of respiratory devices are actually in the hands of patients in the United States.

The agency’s decision puts Lilly further behind in its quest to enter the nearly $20 billion market, which already has drugs for the disease from rivals such as Abbvie, Pfizer, and Johnson & Johnson.

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.

Ravi B. Parikh, M.D., assistant professor in the Department of Medical Ethics and Health Policy and Medicine at the University of Pennsylvania and a staff physician at the Corporal Michael J. Crescenz V.A. Medical Center, discusses the process and how the FDA handles accelerated approval with cancer treatments.

HUTCHMED has completed the rolling submission of its New Drug Application to the FDA for fruquintinib, its candidate for refractor metastatic colorectal cancer.

The company said the decision followed a review of a late-stage study by a data monitoring panel, which showed the drug, reldesemtiv, had no effect in ALS patients compared with placebo.

Vanda Pharmaceuticals has prevailed in its case against the FDA. On Monday, a federal court sided in favor of Vanda in its Freedom of Information Act case against the agency regarding its sleep drug label expansion.