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The Latest Breaking News from FDA

Pfizer seeking FDA clearance for COVID shot in children under 5

Pfizer Inc. and partner BioNTech SE have begun submitting data to U.S. regulators for authorization of their COVID-19 vaccine in children 6 months to 4 years old, according to people familiar with the matter, hastening an effort to get shots to younger kids after the omicron wave caused pediatric infections…

Tribune News Service

FDA Approves First Injectable For HIV Pre-Exposure Prevention - GSK, Pfizer Backed Treatment

The FDA has approved ViiV Healthcare's Apretude (cabotegravir extended-release injectable suspension

Benzinga

Under 5s may be weeks away from Covid shots – what you need to know

Vaccine may be available to youngsters below the age of five from February, if FDA approval is granted

The Independent UK

From analysis to the latest developments in health,
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Attention Biotech Investors: Mark Your Calendar For These Key February PDUFA Dates

After a fairly robust 2021, the new year started on a mixed note as far as regulatory decisions are concerned.

Benzinga

A Fireside Chat with Greg Duncan - CEO of Virios Therapeutics

NASDAQ:VIRI

Benzinga

COVID vaccines could be available for kids under 5 by end of February

Pfizer is expected to submit a request to the FDA as soon as tomorrow for emergency-use authorization.

Axios

Moderna gains full FDA approval for COVID-19 vaccine while Novavax makes push for its own shot

WASHINGTON — Moderna Inc.’s vaccine for COVID-19 received full approval from the U.S. Food and Drug Administration for people 18 and older, an important milestone that bolsters the shot’s use as a major weapon against the virus.

Tribune News Service

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Ivermectin: What is the controversial drug Laurence Fox and Joe Rogan claim to have taken to treat Covid?

Ex-actor and Reclaim Party leader latest right-wing personality to promote treatment most commonly used as anti-parasitic for livestock after testing positive for coronavirus

The Independent UK

COVID vaccine for kids under 5 could come earlier than expected, ex-FDA chief says

Getting vaccines approved for the youngest children would not only be a relief for worried parents, but could help protect against disruptive school and daycare closures.

Axios

FDA Approves Takeda's Vonvendi As Prophylactic Treatment In Bleeding Disorder

The

Benzinga

Moderna's COVID-19 Vaccine Becomes Second To Score Complete FDA Approval

The FDA has given complete approval to Moderna Inc's (NASDAQ:

Benzinga

Veru's Cancer Candidate Sabizabulin Gets FDA Fast Track Tag For COVID-19

The FDA has granted Fast Track designation to Veru Inc's (NASDAQ:

Benzinga

FDA fully approves Moderna's COVID vaccine

Moderna's vaccine will now be marketed as Spikevax.

Axios

Moderna announces full US approval for its COVID-19 vaccine

Moderna says U.S. health regulators have given full approval to its COVID-19 vaccine after reviewing additional data on its safety and effectiveness

The Independent UK

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Benzinga

Psyched: UK Streamlines MDMA Therapy, FDA OKs MindMed's First LSD Trial In 40 years, Atai Launches Subsidiary

The Week In Psychedelics

Benzinga

Altimmune's Mid-Stage Pemvidutide Study Cleared By FDA For Obesity

The FDA has cleared Altimmune Inc's (NASDAQ:

Chronicle Live

What is Ivermectin and why have Laurence Fox and Joe Rogan taken it to 'treat' Covid?

A drug used to fight parasites and de-worm animals, ivermectin has not been deemed safe to treat Covid in the UK or USA

Bangkok Post

Sinovac applies to register vaccine for 3-year-olds

Sinovac, the manufacturer of CoronaVac Vaccine, has applied for registration of its vaccine for use with children aged three years and over, Public Health Minister Anutin Charnvirakul said on Monday.

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The Guardian - US

‘We are so tired’: US parents and doctors say kids under five left behind in Covid vaccine race

Child Covid cases have increased dramatically due to Omicron, yet no vaccine seems on the horizon for this age group

Benzinga

FDA Approves Insulet's Omnipod Automated Insulin Delivery System Patients Aged 6 Years & Above

The

Benzinga

Eli Lilly Expects FDA Rejection For Expanded Use Baricitinib For Eczema

Based on top-line efficacy results from two pivotal Phase 3 trials Eli Lilly And Co (NYSE: LLY) has decided to

Benzinga

Regeneron, Sanofi Withdraw FDA Application For Libtayo's Expanded Use

Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and its partner Sanofi SA (NASDAQ: SNY) have

Benzinga

Benzinga Pro's Top 5 Stocks To Watch For Friday, Jan. 28, 2022: PODD, KR, TEAM, GOOGL, SBUX

Today's 5 Stock Ideas: Insulet (PODD) - Shares up premarket. The company announced FDA clearance of its Omnipod 5 Automated Insulin Delivery System. Kroger (KR) - Shares down premarket. Citigroup downgraded

Benzinga

The Daily Biotech Pulse: Biogen Liquidates Out Of Biosimilar JV, Provention Bio Plots Diabetes Drug Resubmission, Merck Finds COVID Pill Effective Against Omicron

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

Benzinga

FDA Gives Green Signal To Provention Bio's Delaying Diabetes Med Resubmission

Provention Bio Inc (NASDAQ: PRVB) said that it had resolved the comparability concerns with the FDA, and

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