
Besremi was approved in November to treat adults with polycythemia vera.

Livtencity, manufactured by Takeda, was approved in November 2021 and is the first therapy to treat cytomegalovirus infection after transplants.

The new boxed warning for Xeljanz, Olumiant, and Rinvoq includes the risk of cardiovascular adverse events and cancer.

Glass has been detected in the two lots of Veklury, which is used to treat patients who are hospitalized with COVID-19.

Both Copiktra and Farydak had received accelerated approvals, and the FDA had required confirmatory trials. Secura Bio has determined such trials are not feasible.


The approval marks the ninth indication for Darzalex Faspro, the only subcutaneous anti-CD38 monoclonal antibody approved to treat multiple myeloma across multiple treatment regimens.

A temperature change during shipping could impact the product’s effectiveness. Enoxaparin is used to prevent deep vein thrombosis.

The warnings section of Inrebic, a JAK inhibitor to treat a bone marrow cancer, now includes information about the cardiovascular risk associated with Xeljanz, another JAK inhibitor to treat arthritis.

The FDA is reviewing Reblozy to treat anemia in patients with beta thalassemia. The PDUFA action date is March 27, 2022.

CMS is not requiring payment for pharmacists’ testing, patient assessment, ordering/prescribing and dispensing for oral COVID-19 antiviral drugs.

PreHevBrio is a three-antigen hepatitis B vaccine for adults in the United States. It is expected to be available in the first quarter of 2022.

The FDA has set a PDUFA action date of April 1, 2022.

ICER’s first scorecard of the barriers to fair access to medications found that more transparency is needed to fully assess insurers and their coverage policies.

The FDA has assigned a Prescription Drug User Fee Act goal date of Sept. 10, 2022, for deucravacitinib. If approved, it would be the first TYK2 inhibitor approved for the treatment of any disease.

If the FDA authorizes molnupiravir, it would be the first oral anti-viral to treat COVID-19 that patients can take at home.

Findings show substantial variation in payer-negotiated prices and self-pay cash prices at top-performing U.S. hospitals and considerable markups on clinician-administered drugs.

The regulatory agency has set a Prescription Drug User Fee Act date during the first quarter of 2022

Cytalux is the first imagining agent to illuminate ovarian cancer during surgery.

The study found that nearly half of Americans diagnosed with high blood pressure do not have it sufficiently controlled.

Merck now says molnupiravir reduces the risk of hospitalization or death from COVID-19 by 30% after all data have been analyzed. Previously, an interim analysis showed a 50% reduction in hospitalization or death.

Moderna and Pfizer are assessing their vaccines against the Omicron variant, which was first identified in South Africa.

Across all payers, the use of generic statins has resulted in a savings of $11.9 billion annually.

New requirements resulted in long call wait times, which has led to patient access issues.

Patients who are part of the Walgreen’s Prescription Savings Club can receive Semglee at up to 80% off the cash price.

Livtencity is the first therapy approved to treat cytomegalovirus infection, which is common after transplants.