Regulatory Updates

Opzelura is the first and only topical formulation of a JAK inhibitor approved in the United States.

Tivdak is the first approved antibody-drug conjugate for the treatment of adult patients with recurrent or metastatic cervical cancer.

The FDA assigned a PDUFA action date of March 20, 2022, for ganaxolone.

In trials, Skyrizi demonstrated improvements in clinical remission and endoscopic response as both induction and maintenance therapy

The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 19, 2022.

Biogen/Samsung Bioepis’ Byooviz is a biosimilar of Genentech’s Lucentis.

The approval comes more than two months ahead of its PDUFA target date of December 4, 2021.

The vaccines advisory committee voted late on Friday, September 17, 2021, to provide emergency authorization of Pfizer’s COVID-19 vaccine as a booster for those over the age of 65, as well as for those at high risk of developing severe disease.

Rinvoq achieved primary and secondary end points compared with placebo.

The combination of bamlanivimab/etesevimab can now be given to both treat and prevent COVID-19 infection after exposure.

Takeda Oncology’s Exkivity treats non-small lung cancer in patients with EGFR exon 20 insertion mutations. This is the second approval for this mutation and the first oral therapy.

The FDA has set a Prescription Drug User Fee Act target action date of April 30, 2022.

The agency has granted accelerated approval to Brukinsa as a second-line treatment for patients with marginal zone lymphoma, a group of slow-growing non-Hodgkin lymphomas.

The PDUFA date has been set for July 12, 2022.

Jardiance demonstrated a 21% relative risk reduction for the composite primary endpoint of cardiovascular death or hospitalization for heart failure.

Officials with OptumRx predict four new therapies that are expected to an impact on patients and on the market.

The therapy, to be launched in October, is delivered quickly to the bloodstream by targeting the upper nasal space.

The CDC and the FDA have updated their recommendations for the 2021-2022 flu season.

The FDA’s review of the JAK inhibitor class concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with these arthritis and ulcerative colitis medicines.

Investigators says Janssen’s Invega Hafyera offers longer-term symptom control with the fewest doses per year, which may support greater patient adherence.

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.

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.