Politics and Policy

The approval follows the FDA’s Oncologic Drugs Advisory Committee voting 5-3 in favor of maintaining the approval despite a confirmatory trial that found Keytruda did not meet the end points of overall survival and progression-free survival.

The combination bamlanivimab and etesevimab can resume use and distribution to treat mild-to-moderate COVID-19 but only in states where variants resistant to the therapy are low.

Tablets, oral solution, and IV dosage forms are now approved as both monotherapy or adjunctive therapy for the treatment of partial-onset seizures in patients one month of age and older.

Tecentriq did not meet the primary end point in a postmarketing study as a first-line treatment.

Public insurers such as Medicaid, especially in states that expanded coverage under the ACA, kept people insured.

Tibsovo is the first targeted therapy for IDH1-mutated cholangiocarcinoma, a cancer of the bile ducts within and outside the liver.

Developed by Ascendis Pharma, this is the first therapy that delivers growth hormone over one week.

Xarelto is now indicated to help reduce the risks of major cardiovascular events in patients with coronary artery disease and major thrombotic vascular events.

Now called Comirnaty, the vaccine is approved for those 16 years and older.

The FDA has set a PDUFA date of December 23, 2021.

Generics of Chantix, Durezol, Eliquis, and injection potassium/sodium are approved while generics of Tegretol and Levophed are launched.

The therapy is expected to be available by early September.

This vaccine protects against tick-borne encephalitis in people over the age of 1 year.

Trials result show that Lyumjev compares favorably to Humalog.

This is the first approval of generic version of Chantix, and it comes just weeks after a recall of the brand-name drug.

The decision follows an advisory committee recommendation not to approve because of safety issues.

A decision on the plaque psoriasis therapy is expected in the second quarter of 2022.

The therapy can now be used for post-exposure prevention in people at high risk for progression to severe disease.

The PDUFA date has been set for December 4, 2021; FDA has designated this as a Priority Review.

The PDUFA date for this indication is December 4, 2021.

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.