Drugs

Melinta’s Baxdela Expanded Approval for Pneumonia

FDA has approved a Melinta Therapeutics supplemental NDA for Baxdela (delafloxacin) for treating adult patients with community-acquired bacterial pneumonia caused by designated susceptible bacteria. Approval was based on data from a Phase 3 study that compared Baxdela to moxifloxacin. The study results demonstrated that Baxdela met all key primary and secondary endpoints in the trial, the company says. In the intent-to-treat population, Baxdela met the FDA primary endpoint of statistical non-inferiority for “early clinical response” at 96 hours after therapy initiation (88.9%) compared to moxifloxacin (89.0%), it says. Baxdela was approved by the agency in 2017 for treating adult patients with acute bacterial skin and skin structure infections caused by designated susceptible bacteria.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome