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Latest Emergency Use Authorization Stock News

Labcorp Receives FDA Emergency Use Authorization for Mpox PCR Test Home Collection Kit

April 10
Last Trade: 209.70 -0.67 -0.32

The first at-home mpox testing kit provides patients with convenience and privacy to test for mpox, supports physicians in detection and treatment BURLINGTON, N.C., April 10, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Mpox  PCR Test Home...Read more


Invivyd Announces FDA Authorization for Emergency Use of PEMGARDA™ (Formerly VYD222) for Pre-exposure Prophylaxis (PrEP) of COVID-19

PEMGARDA (pemivibart) is authorized in the U.S. for PrEP of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise Emergency use authorization based on positive immunobridging data and on safety data from the CANOPY clinical trial along with ongoing in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1 PEMGARDA is the first PrEP monoclonal antibody (mAb) to receive EUA from the...Read more


Invivyd Submits Request for Emergency Use Authorization (EUA) to U.S. FDA for VYD222 for the Pre-exposure Prevention of COVID-19 in Immunocompromised Adults and Adolescents

January 3
Last Trade: 2.40 0.03 1.05

EUA submission is based on positive initial results from the ongoing CANOPY Phase 3 pivotal clinical trial and ongoing in vitro neutralization activity against relevant SARS-CoV-2 variants VYD222 demonstrates continued in vitro neutralization activity against major SARS-CoV-2 variants, including JN.1, currently the fastest growing variant in the U.S. Company continues preparations for potential commercial launch if EUA is...Read more


Co-Diagnostics Completes Submission to FDA for Co-Dx PCR Pro

December 27
Last Trade: 1.11 0.04 3.26

The Company's Emergency Use Authorization submission is for the new Co-Dx PCR Pro instrument and COVID-19 test kit, designed for point-of-care and at-home. The menu of tests in development for the platform includes TB, HPV, and a multiplex respiratory panel for flu A/B, COVID-19, and RSV SALT LAKE CITY, Dec. 27, 2023 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq-CM: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company...Read more


Novavax 2023-2024 COVID-19 Vaccine Now Authorized and Recommended for Use in the U.S.

October 3
Last Trade: 14.15 1.04 7.93

This Emergency Use Authorization and CDC recommendation makes Novavax's vaccine the only protein-based non-mRNA COVID vaccine option in the U.S. Novavax expects doses will be available in thousands of locations across the U.S. in the coming days, including CVS Pharmacy and Rite Aid Find Novavax's vaccine at us.novavaxcovidvaccine.com or vaccines.gov GAITHERSBURG, Md., Oct. 3, 2023 /CNW/ -- Novavax, Inc. (Nasdaq: NVAX), a...Read more


Symetryx Increases Non-Binding Offer to Acquire Check-Cap to $4.60 Per Share

TORONTO, ON, July 25, 2023 /CNW/ - Today, Symetryx Corporation ("Symetryx") announced an increase in price per share for our non-binding proposal to acquire common shares of Check-Cap LTD (NASDAQ: CHEK) ("Check"). In our press release dated July 18, 2023 ("July 18 Press Release"), Symetryx announced a non-binding offer to purchase Check common shares at $4.35 per share in cash. Symetryx now revises our non-binding proposal to pay $4.60...Read more


Biophytis has Requested a Pre-Submission Meeting with the FDA for an Emergency Use Authorization of Sarconeos (BIO101) for the Treatment of COVID-19

PARIS, FRANCE and CAMBRIDGE, MA / ACCESSWIRE / July 20, 2023 / Biophytis SA (Nasdaq CM:BPTS) (Euronext Growth Paris:ALBPS), ("Biophytis"), a clinical-stage biotechnology company specialized in the development of therapeutics that are aimed at slowing the degenerative processes associated with aging and improving functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering...Read more


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