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The Latest Breaking News from FDA

A proposal to import drugs from other countries creates an unusual alliance in the Senate

Harmony is not often found between two of the most boisterous senators on Capitol Hill, Bernie Sanders, I-Vt., and Rand Paul, R-Ky.

Tribune News Service

Doctors ‘thrilled’ to order COVID vaccines for young kids after DeSantis changes course

MIAMI — Pediatricians across Florida have begun ordering COVID-19 vaccines for their patients under 5 after Gov. Ron DeSantis changed course Friday and allowed doctors and hospitals in the state to get them from a federal program.

Miami Herald

COVID shots for infants, preschoolers OKed to begin in the coming week

The approval Saturday from Dr. Rochelle Walensky, the CDC’s director. expands the nation’s coronavirus vaccination campaign to children as young as 6 months old.

Chicago Sun-Times

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Kids under 5 can get COVID vaccines next week after CDC approval

CDC Director Walensky has agreed with the recommendation the Moderna and Pfizer shots be given to children as young as six months old.

Axios

CDC recommends Covid vaccines for infants, toddlers and preschoolers

Children as young as six months will be able to get shots from either Pfizer or Moderna after Friday’s FDA approval

The Guardian - US

US children under five may receive Covid vaccine from next week after CDC gives rollout green light

‘We know millions of parents and caregivers are eager to get their young children vaccinated, and with today’s decision, they can,’ says CDC Director Dr Rochelle Walensky

The Independent UK

CDC advisers recommend COVID-19 shots for children under 5

U.S. health advisers have recommended COVID-19 vaccines for infants, toddlers and preschoolers — the last group without the shots

The Independent UK

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FDA approves COVID-19 shots for children under 5

U.S. kids under 5 — roughly 18 million youngsters — are eligible for the shots.

Chicago Sun-Times

The FDA authorizes COVID-19 shots for infants and preschoolers

The vaccinations for children as young as 6 months old could start next week. But first, the Centers for Disease Control and Prevention must sign off.

WEKU

With COVID shots approved for toddlers, here’s what you need to know

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.…

Tribune News Service

US: FDA authorises COVID-19 vaccines for children under 5

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

Al Jazeera

Gov. Ron DeSantis reverses, allowing Florida health care providers to order vaccines for young children

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.

McClatchy Washington Bureau

Government-Funded Smoking Cessation Trial Uses Mydecine's New Psilocybin-Derived MYCO-001, Recently FDA-Approved

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.

Benzinga

At last, COVID-19 shots for little kids – 5 essential reads

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.

The Conversation

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Benzinga

BMO Capital Sees Almost 300% Upside On Centessa Stock

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.…

Benzinga

BMO Initiates Coverage On This Gene Editing Spearhead

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 Independent UK

Biden celebrates ‘huge relief’ for parents as FDA authorises Covid vaccine for young kids

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

Benzinga

Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Nod For Kids As Young As Six Months

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…

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Benzinga

The Daily Biotech Pulse: Addex Terminates Parkinson's Study, Expanded Use Of Rhythm's Obesity Drug, FDA Approval For AbbVie's Skyrizi In Crohn's Disease

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

The Guardian - US

US authorizes first Covid vaccines for infants and preschoolers

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

Tribune News Service

FDA clears Moderna, Pfizer COVID shots for children 5 and under

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.

Benzinga

Kazia Therapeutics' Shares Gain Following FDA Orphan Drug Status For Childhood Brain Cancer Drug

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.

Axios

FDA authorizes COVID vaccines for children as young as 6 months

The shots could start being administered as early as next week.

The Independent UK

FDA authorizes 1st COVID-19 shots for infants, preschoolers

U.S. regulators have authorized the first COVID-19 shots for infants and preschoolers

The Conversation

Decades of research document the detrimental health effects of BPA – an expert on environmental pollution and maternal health explains what it all means

Whether or not you’ve heard of the chemical bisphenol A, better known as BPA, studies show that it’s almost certainly in your body. BPA is used in the manufacturing of products like plastic water bottles, baby bottles, toys and food packaging, including in the lining of cans.

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