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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
Moderna released top line data yesterday from a pediatric study of its mRNA COVID-19 vaccine, which showed a half-dose of the vaccine to be safe and effective in kids ages six up to 12 years old. Read More
Agenus has yanked its biologics license application (BLA) for PD-1 inhibitor balstilimab for consideration of accelerated approval for cervical cancer at the FDA’s request — and claims the agency played favorites in approving Merck’s blockbuster Keytruda (pembrolizumab) for the same indication. Read More
Moderna’s and Johnson & Johnson’s COVID-19 boosters, along with mixing and matching of shots, was greenlighted unanimously by scientific advisers to the Centers for Disease Control and Prevention (CDC) on Thursday, just after FDA approved the two boosters for limited populations. Read More
The number of FDA approvals of competitive generic therapy (CGT) abbreviated new drug applications (ANDAs) rose sharply in fiscal 2021, while approvals for priority generics remained relatively flat when compared with 2020 numbers. Read More
The FDA yesterday authorized boosters of both the Moderna and Johnson & Johnson (J&J) COVID-19 vaccines for emergency use. The agency also authorized a “mix and match” approach for emergency use that allows people to receive a booster with a different drugmaker’s product to the one they received in their initial vaccination. Read More