Politics and Policy

The FDA is expected to make a decision on this indication by December 1, 2021.

The therapy had received accelerated approval in 2011 but a phase 3 confirmatory trial found it did not meet the end point of progression-free survival.

This is the first new approval for lupus in a decade.

The agent targets excessive daytime sleepiness.

Pharmacies will need to obtain pre-dispense authorization for clozapine.

The FDA is requesting an additional study to demonstrate tenapanor lowers serum phosphorus.

The approval allows for substitution at the pharmacy counter for Lantus, its reference product.

The FDA would like to see additional data on clinical benefit for patients with anal cancer.

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

Keytruda gets a full approval in endometrial cancer; while Xeljanz will miss another PDUFDA date.

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.