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The Latest Breaking News from FDA

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.

Bangkok Post

‘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

The Guardian - US

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

The

Benzinga

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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

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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

Benzinga

TG Therapeutics Falls 30% As CEO Discloses Partial Clinical Hold On Blood Cancer Trials

TG Therapeutics Inc's (NASDAQ: TGTX) CEO Michael Weiss said that the FDA has

Benzinga

Philips Recalls Trilogy Evo Ventilators, Repair Kits For Potential Health Risks

The FDA has classified Koninklijke Philips NV's (NYSE: PHG) expanded recall of certain ventilators late last year as Class 1, or the most serious type of recall.

Benzinga

Editorial: Get more kids vaccinated against COVID, yes, but two bills need more work

Despite the number of “breakthrough” infections with the omicron variant, California kids and their schools would be safer if more students were vaccinated against COVID-19. Two new bills aim to accomplish that — one would mandate vaccination to attend school and the other would allow kids 12 and older to…

Los Angeles Times

Groups seek to shape final rule to ease hearing aid accessibility

WASHINGTON — The Food and Drug Administration is working to finalize a rule that would make it easier for many adults to get hearing aids, a policy change five years in the making that is sparking intense lobbying.

Tribune News Service

Cortexyme Stock Plunges On FDA Hold On Atuzaginstat's IND

The

Benzinga

FDA Approves First T Cell Receptor Therapy From Immunocore For Eye Cancer

The

Benzinga

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Benzinga

The Daily Biotech Pulse: Gilead's Blood Cancer Studies Placed On Partial Clinical Hold, Immunocore Gets FDA Nod, NRx Touts Positive COVID-19 Data

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

Benzinga

MindMed Shares Soar After FDA Approves First Commercial Clinical Trial On LSD In 40 Years

MindMed (NASDAQ: MNMD), a drug development company in the psychedelics space, announced on Tuesday that the FDA has allowed an investigational new drug application for a Phase 2b trial on a proprietary LSD analog.

Benzinga

FDA Puts Clinical Hold On Gilead's Magrolimab/Azacitidine Combo Trials In Blood Cancer Settings

The

Roll Call

Groups seek to shape final rule to ease hearing aid accessibility - Roll Call

President Biden touts the proposal as a way to lower prices, as only 1 in 5 Americans who could benefit from a hearing aid uses one.

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Benzinga

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The Independent UK

DeSantis blasts FDA for halting drugs ineffective on omicron

Florida Gov. Ron DeSantis has vowed to fight a decision from federal health regulators to block two coronavirus antibody treatments after the drugs were found to be ineffective against treating the widespread omicron variant

Benzinga

Genentech's Evrysdi Application Under FDA Priority Review For Use In Babies Below 2 Months

The

Benzinga

FDA Guides Annovis Bio For Two Phase 3 Buntanetap Trial In Parkinson's Disease

Annovis Bio Inc (NYSE: ANVS) has

Benzinga

Psychedelic Medicine Co. PharmaTher Provides Update On Pipeline And Milestones For 2022

This article was originally published on Microdose and appears here with permission.

The Independent UK

FDA revokes approval for Covid antibody drugs that don’t work against Omicron prompting DeSantis pushback

Florida governor pushes back against decision, calling it ‘sudden and reckless’

Benzinga

The Daily Biotech Pulse: Pfizer-BioNTech Starts Omicron-Specific Vaccine Study, J&J Misses On Topline, Sierra Oncology Reports Positive Data

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

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