The Latest Breaking News from FDA

The stock market gained but the Dow Jones inched lower on the eve of three-day weekend. Oil stocks tumble.

The U.S. Food and Drug Administration authorized COVID-19 vaccines for children under 5 years old Friday, a welcome relief to parents of the last age group to become eligible for shots. Although the move will help protect children from infection and serious disease, vaccine hesitancy still looms in the U.S.…

President Joe Biden says jabs could be rolled out to that age group as early as next week, pending CDC recommendations.

WASHINGTON — Florida Gov. Ron DeSantis is now allowing health care providers, including pediatricians and children’s hospitals, to order COVID-19 vaccines from a federal program for children between 6 months and 5 years old, a reversal from earlier this week, White House officials told McClatchy.

Biotech company Mydecine Innovations Group (OTC: MYCOF) received FDA approval for their novel proprietary MYCO-001. This is the first clearance of the company’s drug product. 

For many parents of kids under age 5, a safe and effective COVID-19 vaccine could not come soon enough. A full year and a half after shots first became available for adults, their wait is nearly over.

BMO Capital has initiated coverage on Centessa Pharmaceuticals plc (NASDAQ:CNTA) with a price target of $19 (293% upside), and an Outperform rating. The analyst writes that ZF874 is a differentiated oral therapy as it addresses the root cause of AATD. Early ZF874 data (N=2) demonstrated therapeutic efficacy in patients, but liver toxicity was also flagged.…

BMO Capital initiated coverage of Intellia Therapeutics Inc (NASDAQ:NTLA) with a Market Perform rating and a $54 target price.  The analyst says Intellia's gene-editing platform could potentially deliver transformative therapies.  But challenges around the lack of clarity around an IND approval in the U.S., ongoing CRISPR/Cas9 IP litigations with Editas Medicine Inc (NASDAQ:EDIT), and high patient…

The Dow Jones rallied. World Wrestling Entertainment CEO Vince McMahon stood aside amid a probe. WWE stock fell. Moderna got a vaccine boost.

‘Today is a day of huge relief for parents and families across America,’ Biden says

The FDA has granted emergency use authorization (EUA) to Pfizer Inc (NYSE:PFE) and BioNTech SE's (NASDAQ:BNTX) COVID-19 Vaccine as a three 3-µg dose series for children six months through 4 years of age.  Based on safety, tolerability, and immunogenicity data, the 3-µg dose was carefully selected as the preferred dose for children under five. The EUA…