The Latest Breaking News from FDA

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…

‘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…

Here's a roundup of top developments in the biotech space over the last 24 hours:

FDA’s action follows its advisory panel’s unanimous recommendation for the shots from Moderna and Pfizer

COVID vaccines for children ages 5 and under from Pfizer Inc. and Moderna Inc. received authorization from U.S. regulators, meaning almost all of the American population can soon get protected against COVID-19 disease.

The United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to Kazia Therapeutics’ (NASDAQ: KZIA) Paxalisib for the treatment of atypical rhabdoid / teratoid tumors (AT/RT), a rare and highly-aggressive childhood brain cancer.