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The Latest Breaking News from FDA

Pune private hospitals more equipped with medical oxygen: Food and Drug Administration

PUNE: Private hospitals in the district were better equipped on the medical oxygen availability front as compared to the civic hospitals, said the Food and Drug Administration.

The Times of India

The Daily Biotech Pulse: Big Pharma Earnings Prove Lackluster, Mersana Inks $1B ADC R&D Deal, Syros Gets Orphan Drug Designation

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

Benzinga

Police raid sausage factory after 9 children hospitalised

Consumer protection police raided a sausage factory in Chon Buri and seized products worth about 700,000 baht for examination after children in five provinces developed a blood disorder after eating food produced there.

Bangkok Post

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Sleep expert weighs in on America’s increased use of melatonin to sleep

Melatonin is an over-the-counter sleep aid that’s loosely regulated by the FDA

The Independent UK

Why Did LogicBio Therapeutics Shares Plunge To 52-Week Low Today?

The FDA has placed a clinical hold on LogicBio Therapeutics Inc's (NASDAQ:

Benzinga

Stock Wars: Axsome Therapeutics Vs. Global Blood Therapeutics

Benzinga’s weekly Stock Wars matches up two leaders in a major industry sector with the goal of determining which company is the better investment.

Benzinga

EXPLAINER: COVID vaccines for kids under 5: What's next?

COVID-19 vaccines for kids under 5 may be available in the U.S. as early as March, but there are several hurdles still to clear

The Independent UK

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Flora Growth's New CBD Formulation To Prevent Infection From COVID 19, Pending Regulatory Approval To Launch Clinical Trials

Cannabis producer Flora Growth Corp. (NASDAQ: FLGC) announced today that its seeking approval from INVIMA, the Colombian FDA, to begin research on their patent-pending, cannabinoid-based product, citing recent studies stating the possibility of cannabinoids to display viral inhibition.

Benzinga

FDA Asks Pfizer - BioNTech To Submit For COVID-19 Vaccine Emergency Use Nod For Youngest Children

Pfizer Inc (NYSE: PFE) and its partner BioNTech SE (NASDAQ: BNTX) have

Benzinga

Pfizer seeks US authorization of Covid vaccine for children under five

FDA decision could come within weeks but big obstacles remain to getting all children inoculated

The Guardian - US

Pfizer Seeks US Approval of Covid Vaccine for Children under 5

Pfizer and BioNTech said Tuesday they are seeking emergency authorization from US health regulators for use of their Covid vaccine for children aged over six months and under five years. If the Food and Drug Administration (FDA) authorizes the two-shot regimen, it will become the first Covid vaccine available to…

Asharq Al-Awsat

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

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Benzinga

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

Axios

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.

Tribune News Service

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.

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The Independent UK

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

Axios

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.

Benzinga

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:

Axios

FDA fully approves Moderna's COVID vaccine

Moderna's vaccine will now be marketed as Spikevax.

The Independent UK

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

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