Politics and Policy

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.

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.

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.

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.

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

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

Several new generics have launched in the United States, including for the migraine therapy Zomig, the anticancer therapy Doxil, and an anti-inflammatory used to treat respiratory conditions associated with COVID-19.

If approved, Bluebird Bio’s beti-cel would be the first one-therapy for β-thalassemia. The PDUFA date is May 20, 2022.

Pfizer/BioNTech plan to use this data to support submissions for full approval of the vaccine in those 12 to 15 years old.

Bulevirtide has been granted breakthrough therapy and orphan drug designations by the FDA.

BioMarin’s Voxzogo is expected to be available in the United States by mid- to late-December.

The boosters are now authorized for all people 18 years of age and older.

The FDA needs additional time to assess information about proposed risk revaluation mitigation strategy for the treatment for obstructive hypertrophic cardiomyopathy.

Keytruda is the first immunotherapy approved for treatment of patients with early renal cell carcinoma after surgery.

If authorized, Paxlovid would be the first oral 3CL protease inhibitor specifically designed to combat the virus that causes COVID-19.

Besremi is the first interferon approved to treat a disease that causes the overproduction of red blood cells.

If approved, Jardiance would be the first treatment for adults across the full spectrum of heart failure regardless of ejection fraction.

Previously, the FDA had issued an EUA for those over the age of 65 and those at high risk for severe COVID-19 or exposure to the virus.

Eprontia is the first liquid formulation of topiramate approved to both treat and prevent seizure.

The FDA didn’t have enough data to assess the risks and benefits of Zyesami.

UK regulatory authorities approved molnupiravir to treat patients with mild-to-moderate COVID-19.

The agency needs more time to review new information on the analytical method used.