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The Latest Breaking News from FDA

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

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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

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…

Benzinga

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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

The Independent UK

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…

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:

Benzinga

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

The Guardian - US

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.

Tribune News Service

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.

Benzinga

FDA authorizes COVID vaccines for children as young as 6 months

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

Axios

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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.

Benzinga

Rhythm Pharma Secures Non-Dilutive Financing Of $100M To Use Of This...

Rhythm Pharmaceuticals Inc (NASDAQ:RYTM) entered into a Revenue Interest Financing Agreement with HealthCare Royalty Partners for a total investment of $100 million. Rhythm intends to use the proceeds to support global commercialization efforts for its newly approved Imcivree (setmelanotide) and ongoing clinical development. With this new approval, Imcivree is indicated for chronic weight management…

Salon

Why the kids' vaccine took so long

One and a half years after the adult COVID-19 vaccine, a kids' shot is here. This is why it took so much longer

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Miami Herald

DeSantis defends state decision not to order COVID vaccines for young kids

Gov. Ron DeSantis on Thursday defended the state’s decision not to preorder COVID-19 pediatric vaccines for children under 5, saying that parents who want the shots can access them without the state’s help.

Benzinga

Rhythm Pharmaceuticals' Shares Dive Following FDA's Verdict On IMCIVREE Drug

The U.S. Food and Drug Administration (FDA) has approved Rhythm Pharmaceuticals’ (NASDAQ: RYTM) supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide), a melanocortin-4 receptor (MC4R) agonist, for patients with Bardet-Biedl syndrome (BBS).

ABC News

Pfizer and Moderna COVID-19 vaccines are on the verge of approval for US kids under five. When could it happen in Australia?

After US regulators took a major step towards approving COVID-19 vaccines for kids under five, here's what you need to know about the possibility of something similar happening in Australia.

The Guardian - US

Key US baby formula plant closes again as ‘torrential storms’ cause flooding

Production halt at Abbott Laboratories in Michigan will probably extend shortages for ‘a few weeks’

Benzinga

HC Wainwright Sees Opportunity For Acadia's Alzheimer's Candidate

HC Wainwright says FDA's briefing document on ACADIA Pharmaceuticals Inc's (NASDAQ: ACAD) pimavanserin was not unexpected.

The Independent UK

Baby formula company stops production again due to storms

It is unclear when the facility will restart production

Chicago Tribune

Walgreens to launch business that will connect customers with clinical trials

Some Walgreens customers might soon get a new kind of message from the company, asking if they’d like to participate in a clinical trial.

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