The Latest Breaking News from US Food and Drug Administration

Pre-open movers U.S. stock futures traded higher in early pre-market trade on Wednesday after recording sharp losses on Tuesday following the release of inflation data for August. All the three major indices settled sharply lower, notching their biggest single-session percentage declines since June 2020.

Akero Therapeutics (NASDAQ:AKRO) revealed topline data from HARMONY, a 24-week Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with pre-cirrhotic nonalcoholic steatohepatitis (NASH), the study met its primary endpoint for both the 50mg and 28mg EFX dose groups. Akero Therapeutics shares…

While the COVID-19 pandemic benefitted Johnson & Johnson (JNJ) and Pfizer (PFE) significantly as their vaccines helped the world recover from the crisis, these stocks are more than just COVID-19 plays because of their strong product portfolio and pipeline. They are well-positioned to capitalize on the rising chronic diseases, an…

Pfizer (NYSE:PFE) announced positive top-line data from the Phase 3 clinical trial RENOIR investigating its bivalent RSV prefusion F vaccine candidate, RSVpreF, when administered to adults 60 years of age or older. Pfizer, Inc. shares traded in a range of $47.27 to $47.95 on day volume of 14.45 million shares, closed…

The European Commission (EC) has granted conditional marketing authorization (CMA) to BioMarin Pharmaceutical’s (NASDAQ:BMRN) lead asset ROCTAVIAN (valoctocogene roxaparvovec) gene therapy for the treatment of severe hemophilia A (congenital Factor VIII deficiency) in adult patients. BioMarin shares traded as high as 2.28 percent, in a range of $91.39 to $93.68…

The first hormonal contraceptive (the “pill”) was approved by the US Food and Drug Administration in 1960. Hormonal contraceptives have since become one of the most prescribed drugs in the world, used daily by more than 100 million people worldwide.

Pfizer Inc. and BioNTech SE asked the U.S. to authorize a new COVID-19 booster shot customized against the currently circulating COVID-19 variants as governments race to protect their populations against the ever-mutating virus.

Gritstone bio (NASDAQ:GRTS) announced that interim results from the Phase 1/2 trial of GRANITE, its individualized, vaccine-based immunotherapy candidate for solid tumor cancers, were published today in Nature Medicine. The initial results from the study are expected during second half of 2023. Gritstone shares traded in a range of $3.96 to $4.24…

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Relmada Therapeutics’ (NASDAQ:RLMD) lead asset REL-1017 as a monotherapy for the treatment major depressive disorder (MDD). Relmada shares traded in a range of $26.02 to $27.96 on a day volume of 173.79 thousand shares, closed regular trading…