Denise Myshko

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

New vaccine for pneumococcal disease, an sNDA approved based on real-world data, a new therapy for skin and muscle disease, Keytruda combination receives full approval in endometrial cancer, a new diabetes therapy is approved, and another JAK inhibitor misses PDUFA date round out this week’s FDA news.

When Medicare D plans do provide coverage for first generics, they are often placed on non-generic tiers.

The FDA had approved Kadmon's therapy for graft-versus-host disease July 16.

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.

Eight out of 10 covered U.S. commercial lives now have access to the H. pylori therapy.

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

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

An advisory committee recommends against approving an anemia drug. Darzalex Faspro receives another indication, Bayer receives approval for Kerendia for chronic kidney disease, and FDA delays its decision on sNDAs for JAK inhibitor therapies for atopic dermatitis.

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

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

After generic entry, Zytiga’s market share fell to about 14% and monthly net sales across the entire market fell 85%.

New analysis suggests that even with rebates, the new Alzheimer’s therapy could have implications for Medicaid drug spending.

A permanent code is expected in the third quarter of 2021.

The therapy for opioid-induced constipation has no restrictions on an unidentified national formulary that serves these Blues plans.

Jardiance lowered risk of hospitalization from acute kidney injury but increased risk of hospitalized from diabetic ketoacidosis compared with a DPP4 inhibitor in one interim analysis.

Commercial insurers are beginning to provide coverage information on Biogen’s controversial therapy.

Keytruda loses one indication but gains another, Biogen narrows use of Aduhelm, Padcev gets regular approval and expanded indication, Amgen submits application for asthma biologic, agency issues complete response letter for diabetes prevention therapy teplizumab, Novartis resubmits NDA for inclisiran.

This is the eighth generic version of the drug to treat insomnia.

Orally dissolving film formulation of riluzole is now available for patients who have difficulty swallowing.

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 single-dose antibiotic with a one-hour infusion is approved to treat MRSA and other skin infections.

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.

New, extended-release therapy for post-operative pain reduces the need for opioid pain relief.

Merck will withdraw Keytruda's advanced gastric indication after an FDA panel vote, a drug with supply problems gets a new indication, NDAs for an HIV therapy, and other news.