Weekly FDA Drug Pipeline Calendar (Jan 9 - Jan 14)

BioPharm Insight US wrote a column · Jan 10, 2023 00:10

Hello mooers, welcome to another week of the FDA calendar. Here are what happened last week and what's coming up this week.

BIGGEST MOVERS FROM THIS WEEK

$Vivos Therapeutics (VVOS.US)$ +240% (a FDA 510(k) clearance for its proprietary DNA appliance (daytime-nighttime appliance). The device clearance gives rise to an entirely new treatment regimen for mild-to-moderate obstructive sleep apnea (OSA).)

$Lucira Health (LHDX.US)$ submitted an Emergency Use Authorization (EUA) application to the FDA for over-the-counter (OTC) use of its molecular COVID-19 & Flu test. Lucira's test has previously been granted Emergency Use Authorization for Point-of-Care (POC) use in a healthcare setting in November 2022.

$Bellerophon Therapeutics (Delisted) (BLPH.US)$ +179% (the company announced that it has entered into a license agreement for the development and commercialization of INOpulse with Baylor BioSciences.)

$CytomX (CTMX.US)$ shares closed the week up 124% at $2.42 after it announced a collaboration with $Moderna (MRNA.US)$ to develop therapeutics for oncology and non-oncology conditions.

$Fate Therapeutics (FATE.US)$ ended a collaboration agreement with Janssen Biotech, the company also plans to lay off about 220 employees in the first quarter.

EVENTS TO WATCH

J.P. Morgan Healthcare Conference (Monday- Thursday, January 9-12, 2023)