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November 29, 2021
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.
November 25, 2021
New requirements resulted in long call wait times, which has led to patient access issues.
November 24, 2021
Livtencity is the first therapy approved to treat cytomegalovirus infection, which is common after transplants.
November 23, 2021
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.
November 22, 2021
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.
November 20, 2021
Bulevirtide has been granted breakthrough therapy and orphan drug designations by the FDA.
November 19, 2021
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.
