fdafiling

37 results found.

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02/0902/1402/1702/2302/2803/0303/0803/1303/1603/21
ARDX

Ardelyx Inc

23.58%

$3.35 - $4.14

Feb 7th 2023 - Mar 21st 2023

Positive Reviews Happy Facepositive
Negative Reviews Sad Facenegative

Mar, 21, 2023

This is 100% normal and part of the growth of a st... See more

Mar, 6, 2023

$ARDX very good fda news on this conference call

02/0902/1402/1702/2302/2803/0303/0803/1303/1603/21
EDSA

Edesa Biotech Inc

-24.09%

$1.37 - $1.04

Feb 7th 2023 - Mar 21st 2023

Positive Reviews Happy Facepositive
Negative Reviews Sad Facenegative

Mar, 21, 2023

But what makes it amazing is the investor deck and... See more

Feb, 10, 2023

$EDSA Ruxolitinib (Opzelura) approved by FDA last ... See more

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11/0711/1011/1511/1811/2311/2912/0212/0712/1212/15
AVCT

American Virtual Cloud Technologies Inc

-16.99%

$1.13 - $0.94

Nov 3rd 2022 - Dec 15th 2022

Positive Reviews Happy Facepositive
Negative Reviews Sad Facenegative

Nov, 4, 2022

This formula has already proved to be effective, a... See more

ARDX

Ardelyx Inc

23.58%

$3.35 - $4.14

Feb 7th 2023 - Mar 21st 2023

Positive Reviews Happy Facepositive
Negative Reviews Sad Facenegative

Mar, 21, 2023

This is 100% normal and part of the growth of a strong company with excellent fundamentals and an FDA approval coming this year.

Mar, 6, 2023

$ARDX very good fda news on this conference call

Mar, 4, 2023

And this is just a beginning, FDA approval will take it to the skies.

Feb, 27, 2023

Pretty Bullish ER going to give us an update on FDA when and etc. .

Feb, 8, 2023

If the trend of script numbers is anything to go by, guidance could be way better than Wall Street expects giving us a nice boost before FDA news.

Feb, 3, 2023

$AKBA within 3 to 4 weeks this stock could be over 2 heading to three like $ARDX .. gsk approval has helped.. fda news, ema opinion/ approval, partnership..

Jan, 30, 2023

$ARDX when we get fda approval will be shining

Jan, 19, 2023

This should be seen as a REALLY good thing - because they will need cashflow soon - one would expect - assumption being FDA response is close and production and marketing is about to get kicked up a notch. .

Jan, 4, 2023

Things to look forward to.. NDA refile announcement, Q4 results, weekly IBSRELA sales increasing now that we are through the holidays, FDA approval, Japan approval, launch of Xphozah.

Dec, 28, 2022

They just got approval for 1 drug from FDA and things are bot going well there..

EDSA

Edesa Biotech Inc

-24.09%

$1.37 - $1.04

Feb 7th 2023 - Mar 21st 2023

Positive Reviews Happy Facepositive
Negative Reviews Sad Facenegative

Mar, 21, 2023

But what makes it amazing is the investor deck and website will still say “in talks with fda on phase 3 approval”.

Feb, 10, 2023

$EDSA Ruxolitinib (Opzelura) approved by FDA last year seems like a very solid drug for curing vitiligo and is generating tremendous revenue to Incyte.

Jan, 20, 2023

FDA was pleased with their results and understands HC is moving forward.

Jan, 18, 2023

* granted FDA fast track status late Dec 2022 * 75% of drugs given Fast Track get approved * ARDS current has limited treatment options, could make a big impact * CEO has sold two previous biotech companies to bigger players Let’s get it 😍🎊💥🆙✅

Jan, 17, 2023

Fast Tracked FDA status on a drug with no competition.

Jan, 17, 2023

It looks like EB05 is gonna be that home run, with FDA ‘Fast Track’ designation at the end of Dec 2022, we’re almost at the finish line.

Jan, 17, 2023

FDA mulling over Emergency use right now I bet Holding strong. .

Jan, 15, 2023

but to PR the positive review and approval They did exactly that with Fast Track, and also Compassionate Use BOTH APPROVED BY FDA!

AVCT

American Virtual Cloud Technologies Inc

-16.99%

$1.13 - $0.94

Nov 3rd 2022 - Dec 15th 2022

Positive Reviews Happy Facepositive
Negative Reviews Sad Facenegative

Nov, 4, 2022

This formula has already proved to be effective, and if FDA approved can potentially be sold for billions.