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Takhzyro is the first therapy to prevent attacks of hereditary angioedema (HAE) in children ages 2 to under 6.

Zuranolone is a rapid-acting neuroactive steroid that can take effect in 14 days to treat patients with major depressive disorder and postpartum depression. The FDA has assigned a PDUFA action date of Aug. 5, 2023.

The products may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis.

Trodelvy has been recommended as a preferred treatment for metastatic HR+/HER2- breast cancer by the National Comprehensive Cancer Network.

Tezspire is a biologic that specifically targets the inflammation associated with asthma.

Evernorth, Cigna’s pharmacy and benefits solutions division, contributed more than 75% of the company’s revenue last year.

Daprodustat, now with the brand name of Jesduvroq, is a new oral therapy but it carries a boxed warning about the risk of cardiovascular events.

Elacestrant, now with the brand name Orserdu, is an oral selective estrogen receptor degrader (SERD), which works by blocking the effects of estrogen on hormone receptor-positive breast cancer cells.

Jaypirca is the first BTK inhibitor specifically approved for patients with mantle cell lymphoma previously treated with a covalent BTK inhibitor. It has a wholesale acquisition cost of $21,000 per 30 days of therapy.

This approval marks the fifth indication for Keytruda-based regimens in non-small cell lung cancer and the 34th indication in the United States.

AstraZeneca is developing a next-generation long-acting antibody for pre-exposure prophylaxis of COVID-19, which it plans to make available in the second half of 2023.

Evio is launching a new pharmacy solution that leverages Flipt’s proprietary, cloud-based benefit administration and patient engagement platforms.

The Peripheral and Central Nervous System Drugs Advisory Committee meeting is scheduled for March 22, 2023, to review Biogen’s tofersen.

Once-daily, oral SGLT2 inhibitor Brenzavvy has been shown to reduce blood sugar and improve glycemic control.

A phase 3 trial showed that Jardiance reduced the risk of kidney disease progression or cardiovascular death in adults with chronic kidney disease by 28% compared with placebo. An FDA decision is expected in the second half of 2023.

Moderna plans to submit to the FDA its investigational mRNA vaccine, RNA-1345, for respiratory syncytial virus (RSV) in the first half of 2023.

Lilly expects topline results from the confirmatory phase 3 trial in the second quarter of 2023 and plans to submit for full approval.

This is the fourth indication for the Bruton’s tyrosine kinase inhibitor.

Tukysa with trastuzumab is indicated for second-line treatment of HER2-positive metastatic colorectal cancer, the first such therapy for this cancer.

There are currently no medications approved for the treatment of NASH, which can lead to cirrhosis, eventual liver failure, cancer and death. The FDA has assigned a PDUFA target action of June 22, 2023, for the therapy, obeticholic acid.

Lawsuit accuses the companies of using unlawful, unfair, and deceptive practices.

Rykindo is a bi-weekly long-acting risperidone injection to treat patients with schizophrenia and bipolar 1 in adults.

Optum Rx’s Humira biosimilar strategy for 2023 was set up to allow for the most value in the first year, said CEO Heather Cianfrocco.

This update removes a previous limitation that it could not be used as the first therapy.

Airsupra is the first rescue medication to manage both the symptoms and the inflammation associated with asthma.

New approvals include gene therapies, first-in-class drugs, treatments for rare diseases, and cancer, as well as biosimilars.

Clarivate analysts have identified the treatments they forecast could deliver annual sales of more than $1 billion within five years. These include therapies for rare diseases, as well as HIV, Parkinson’s disease, Crohn’s disease, alopecia, and cancer.

The agency has assigned a Prescription Drug User Fee Act target action date of May 10, 2023, and plans to hold an advisory Committee

The supplemental BLA is based on data from a confirmatory phase 3 trial. The submission was made the same day Eisai/Biogen received accelerated approval.

Lecanemab, now with the brand name Leqembi, will launch with a wholesale acquisition cost of $26,500 a year.