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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
During its third-quarter earnings report, Eli Lilly announced that it’s pursuing accelerated approval for the investigational Alzheimer’s drug donanemab ― and that it also plans to evaluate the therapy compared to Biogen’s Aduhelm (aducanumab) in a head-to-head study. Read More