Blood cancer patients who had at least some antibodies after the first two doses are likely to produce large amounts after the third vaccination.
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Researchers suggest that adjusting the prescribing patterns of about 8% of physicians could result in substantial savings.
Medexus is working with Ethypharm to generate the data needed to support an abbreviated new drug application for triamcinolone hexacetonide.
The topical anesthetic was found to be “super potent,” which could lead to systemic toxicity and central nervous system and cardiovascular reactions.
The regulatory agency is reviewing Reata’s application of bardoxolone to treat patients with chronic kidney disease caused by Alport syndrome, a rare genetic disease.
The FDA in late November authorized the COVID-19 booster for all people 18 years of age and older.
Evusheld is the only monoclonal antibody authorized in the United States for COVID-19 pre-exposure prophylaxis.
The oral granules formulation allows it to be used with soft foods and with feeding tubes.
Pfizer and BioNTech expect to have an omicron-specific booster ready by March 2022.
Preclinical studies show sotrovimab is active against key mutations of the omicron variant of SARS-CoV-2, which causes COVID-19.
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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.
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