The FDA PDUFA Calendar is a chronological calendar of PDUFA target dates as well as Advisory meetings (ADCOMM). PDUFA target dates are dates by which the FDA aims to deliver their decision regarding an NDA or BLA filing. These decisions can however come before the PDUFA target date.
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$CRISPR Therapeutics(CRSP.US)$$Vertex Pharmaceuticals(VRTX.US)$$OptiNose(OPTN.US)$$Arcutis Biotherapeutics(ARQT.US)$$Calliditas Therapeutics(CALT.US)$$bluebird bio(BLUE.US)$$Glaukos(GKOS.US)$$Ionis Pharmaceuticals(IONS.US)$$Amgen(AMGN.US)$$Merck & Co(MRK.US)$

$Pfizer(PFE.US)$
Details:
Pfizer discontinues its twice-daily experimental weight loss pill due to high rates of adverse side effects.
The pill showed significant weight loss in patients but faced low tolerance in a mid-stage clinical study.
Phase two trial data for a once-a-day version of the drug expected in the first half of 2024.
Pfizer's shares fell 4% in premarket trading after announcing the trial results.
The discontinuation ma...

$Biora Therapeutics(BIOR.US)$ Now looking for 2.49, 2.70, 2.91?

$Biora Therapeutics(BIOR.US)$  FDA effect, turnover of over 1 Mio is often as a sign of party 🥳🎉

S&P 500 is likely to decline to 3,700 next year and possible fall as low as 3,300 warns BCA Research
$SPDR S&P 500 ETF(SPY.US)$$S&P 500 Index(.SPX.US)$

$The Cigna Group(CI.US)$$Humana(HUM.US)$ This deal isn't done yet but it has the potential to change an entire sector
Are two leading health insurance providers about to merge? That question has been on investors’ minds today as speculation mounts that $The Cigna Group(CI.US)$ and $Humana(HUM.US)$  are on the verge of an important deal. According to recent reports, these two top players in the insurance industry are considering a cash and stock de...

$Vivos Therapeutics(VVOS.US)$ Stock is rocketing higher on Wednesday after the U.S. Food and Drug Administration (FDA) approval to its sleep apnea treatment device.
According to a press release from the company, it has been cleaning 510 (k) clearance from the FDA for its nursing care oral applications. That covers its DNA oral appliance, mRNA oral appliance and its mmRNA oral appliance
Vivos points out that this is the first approval...

$S&P 500 Index(.SPX.US)$ On a price-to-earnings basis, the S&P 7 is now as overvalued as tech in 2000 and the Nifty Fifty in 1972.
These are the same stocks that have accounted for 95% of the S&P 500's gain this year.
The P/E ratio on some components of the S&P 7 is now more than DOUBLE the levels seen in previous bubbles.
For example, Nvidia, $NVIDIA(NVDA.US)$ , now has a P/E ratio of 115x.
However, without these 7 companies, the S&P 500 is up just 4% this year.
$Meta Platforms(META.US)$$Amazon(AMZN.US)$$Apple(AAPL.US)$$Alphabet-C(GOOG.US)$$Microsoft(MSFT.US)$$Tesla(TSLA.US)$
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Amid a slow start to the new week, specialty drug developer $Redhill Biopharma(RDHL.US)$ dramatically enlivened the mood. Catapulting sentiment was regulatory approval for Talicia, a therapeutic designed to target helicobacter pylori (H. pylori). Even more enticing, several hedge funds own RDHL stock, indicating possible sustained upside potential.
According to the accompanying press release, the U.S. Food and Drug Administration (FDA) gr...