Regulatory Updates

The therapy is approved for both adults and children.

Azstarys is approved to treat patients 6 years and older.

The company’s stock began dropping on Tuesday with analyst expectation the FDA will issue a Complete Response Letter for tenapanor, its chronic kidney disease therapy.

Vaxneuvance is approved for 15 serotypes, including those that are major causes of disease.

Current drug shortages based on FDA data, prepared by Formulary Watch.

FDA staff raised safety concerns ahead of the advisory panel hearing.

Merck has submitted the data from the study KEYNOTE-522 to the FDA for review.

The first generic of the high-dose intravenous iron, a generic of Feraheme, is now available.

Committee members raised safety concerns about FibroGen/AstraZeneca’s oral therapy roxadustat.

The new indication provides a subcutaneous option for multiple myeloma that can be administrated in minutes, rather than hours.

The prescribing information for Aduhelm now specifies its use in patients with a mild form of the disease.

The agency also granted tezepelumab priority review with a PDUFA date sometime in the first quarter of 2022.

The company is transferring manufacturing of the final product to its own site in Austria.

Despite an advisory committee recommendation for approval, the FDA did not approve what would have been the first disease-modifying therapy for type 1 diabetes.

This approval comes days after Merck announced it would withdraw indication for third-line gastric cancer.

The move follows an April 29 vote by the FDA Oncology Drugs Advisory Committee.

The therapy, a recombinant version, was developed to address supply and manufacturing issues.

The label for the type 2 diabetes treatment has been updated to include the risk of ketoacidosis and damage to the kidney.

Kite plans to submit a supplemental BLA based on these findings.

The authorization is based on four studies that evaluated Actemra in more than 5,500 hospitalized patients.

The longstanding medicine for adults is now approved to treat children 3 months to less than 12 years old with venous thromboembolism.

The therapy would be used to help prevent and treat blood clots in pediatric patients.

Novartis’ investigational targeted radioligand therapy extends survival in patients with advanced metastatic prostate cancer.

The Alzheimer's Association praises the approval but not the price tag. A Harvard Medical School professor who resigned from an FDA advisory committee says the OK "was probably the worst approval decision in recent U.S. history" in his resignation letter.

Today's approval goes against the advice of an outside advisory committee.

Semaglutide injection is a weekly injection for chronic weight management in adults.

About 2% to 3% of patients with nonsmall cell lung cancer have EGFR exon 20 insertion mutations targeted by newly approved Rybrevant.

OptumRx had identified pegcetacoplan as one of the top 5 drugs in the pipeline this year.

The AstraZeneca drug is the first SGLT2 inhibitor approved for chronic kidney disease regardless of whether the patient has diabetes.