Food and Drug Administration (FDA)

AstraZeneca said the FDA awarded the designation to Farxiga to delay the progression of renal failure and prevent cardiovascular and renal death in patients with chronic kidney disease.

Some have wondered why the agency has hit back at Novartis so hard when the data in question didn’t have any effect on the eventual outcomes of the product’s effectiveness and safety.

The regulatory agency expressed concern regarding the risk of infections related to intravenous infusion ports and renal toxicity seen in pre-clinical models of golodirsen and observed following administration of other antisense oligonucleotides, Sarepta said.

The U.S. FDA gave Nabriva Therapeutics a thumbs-up for both its oral and intravenous formulations of Xenleta (lefamulin) to treat community-acquired bacterial pneumonia in adults.

PharmaMar announced that the FDA agreed with PharmaMar’s proposal to file for accelerated approval its New Drug Application (NDA) for lurbinectedin monotherapy for the treatment of second-line SCLC.

AbbVie’s JAK inhibitor Rinvoq was approved by the U.S. Food and Drug Administration for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

The U.S. Food and Drug Administration approved Impact’s Inrebic for the treatment for adult patients with certain types of myelofibrosis, cancers of the bone marrow.

Wrapping up the month of August, there are technically four PDUFA dates on the calendar, although one was approved two months early and another may be delayed as the U.S. Food and Drug Administration reevaluates its policies regarding opioid pain medications. Here’s a look.

The FDA approved Rozlytrek for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer. Also, Rozlytrek secured accelerated approval for the treatment of solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.