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Merck’s and Ridgeback Biotherapeutics’ oral COVID-19 medication got its first green light from a regulatory body this week when the UK approved it, making it the first oral antiviral medicine authorized for the treatment of COVID-19. The companies still await authorization from the FDA, which could come early next month. Read More
The approvals were supported by positive phase 1 and phase 3 data in which Scemblix (asciminib) showed superiority in patients’ major molecular response rate when compared against Pfizer’s Bosulif (bosutinib). Read More
The FDA is taking more time to review Moderna’s COVID-19 vaccine in adolescents age 12 to 17 years over concerns the messenger RNA (mRNA)-based shot may be associated with increased risk of myocarditis, a type of heart inflammation. Read More
In a Complete Response Letter to United Therapeutics, the FDA declined to approve the company’s Tyvaso DPI (treprostinil) drug-device combination for improving exercise capacity in patients with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Read More
Pfizer/BioNtech’s Emergency Use Authorization (EUA) application for a COVID-19 vaccine for young children has cleared its first regulatory hurdle. Read More
The FDA has rejected a citizen petition seeking to revoke the Emergency Use Authorizations (EUAs) of both the Moderna and Johnson & Johnson (J&J) COVID-19 vaccines. Read More