KP.3.1.1 and LB.1 in vitro neutralization potency values now reflected in the PEMGARDA Fact Sheet for Healthcare Providers are in-line with prior variants, including variants represented in the CANOPY Phase 3 clinical trial Invivyd continues active variant monitoring using validated, robust methods and is not aware of any circulating variants not susceptible to PEMGARDA at this time WALTHAM, Mass., Oct. 01, 2024 (GLOBE NEWSWIRE) --...Read more
Novavax expects pre-filled syringes will be broadly available in thousands of locations across the U.S. Novavax's vaccine is the only protein-based option available in the U.S. for use in individuals aged 12 and older to prevent COVID-19 GAITHERSBURG, Md., Aug. 30, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced the Novavax...Read more
Novavax's updated JN.1 COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3 Novavax's JN.1 COVID-19 vaccine would be the only protein-based option available in the U.S. Novavax's filing is aligned with FDA, EMA and WHO global recommendations on vaccine composition Novavax intends to have its vaccine in pre-filled syringes available in the U.S. for immediate release post-authorization and following...Read more
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
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
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
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
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
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
Vilobelimab is the first authorized drug to control complement factor C5a, a protein that plays an important and often harmful role in the body's immune response FDA granted EUA based on Phase III clinical trial results showing a significant relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in critically ill invasively mechanically ventilated COVID-19 patients InflaRx continues the dialogue with FDA to...Read more
MIAMI, FL, March 02, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, today announced that the U.S. Food and Drug Administration (FDA) has declined to grant at this time the Company’s request for Emergency Use Authorization (EUA) for sabizabulin, Veru’s novel microtubule disruptor, to treat hospitalized...Read more
CAMBRIDGE, Mass. / Mar 02, 2023 / Business Wire / Sesen Bio, Inc. (Nasdaq: SESN) (“Sesen Bio” or the “Company”), today announced that its stockholders have voted to approve all proposals, including the pending merger with Carisma Therapeutics Inc. (“Carisma”), at the Company’s Special Meeting of Stockholders (the “Special Meeting”) held earlier today. Dr. Thomas Cannell, President and Chief Executive Officer of Sesen Bio, said, “We are...Read more
Lab-quality results for both COVID-19 and Flu now available at home from one single test COVID-19 and Flu have similar symptoms but different treatments, requiring a fast, differential test to access time-sensitive prescription treatment options Lucira’s COVID-19 & Flu Home Test demonstrated similar performance for COVID-19, Flu A and Flu B in head-to-head comparison study with highly sensitive lab-based PCR tests Lucira seeks a...Read more
Acquisition Will Enhance Bausch + Lomb’s Surgical Portfolio with IC-8® Apthera™ Intraocular Lens Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, and AcuFocus, Inc. (“AcuFocus”), a privately held ophthalmic medical device company, today announced that an affiliate of Bausch + Lomb has acquired AcuFocus, pursuant to a merger...Read more
Assay for Research and Clinical Use Now Globally Available for the BD MAX™ System FRANKLIN LAKES, N.J., Jan. 9, 2023 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and CerTest Biotec have announced Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a molecular polymerase chain reaction (PCR) assay for Mpox virus detection. The...Read more
Medtech Veteran and Catheter Precision CEO and Founder David Jenkins to Serve as Executive Chairman Enters Agreements to Raise up to $9.3 Million in Equity Ra Medical Systems, Inc. (NYSE American: RMED) (“Ra Medical” or the “Company”) announces the completion of its previously announced stock-for-stock merger transaction with Catheter Precision, Inc., a company focused on the cardiac electrophysiology market. Medtech veteran and...Read more
CARLSBAD, Calif.--(BUSINESS WIRE)--Thermo Fisher Scientific, the world leader in serving science, today announced the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Applied Biosystems TaqPath Monkeypox/Orthopox Virus DNA Kit, a polymerase chain reaction (PCR) test designed to detect non-variola Orthopoxviruses, including monkeypox virus, in approximately three-and-a-half hours. The...Read more
Bivalent vaccine authorized as third 3-µg dose in the three-dose primary series Consistent COVID-19 hospitalization rates in this age group coupled with an overall surge in respiratory illnesses among children under 5 in the United States creates urgent need to make updated COVID-19 vaccines available Doses to ship immediately upon recommendation by CDC NEW YORK and MAINZ, GERMANY, DECEMBER 8, 2022 — Pfizer Inc. (NYSE: PFE)...Read more
mRNA-1273.222 Targets the BA.4/BA.5 Strains of Omicron Variant Authorization Is Based Upon Clinical and Pre-Clinical Data for Moderna's Bivalent Vaccines CAMBRIDGE, MA / ACCESSWIRE / December 8, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its...Read more
Kits available Now for Distribution LONDON, Dec. 6, 2022 /PRNewswire/ -- Virax Biolabs Group Limited ("Virax" or the "Company") (Nasdaq: VRAX), an innovative biotechnology company focused on the prevention, detection, and diagnosis of viral diseases, announced today that their supplier has received an Emergency Use Authorization ("EUA") from the U.S. FDA for their Over-the-Counter COVID-19 Rapid Antigen Test (the "Test"). The Tests...Read more
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older. The application follows guidance from the FDA to include clinical data from the companies’ bivalent Omicron BA.1-adapted vaccine...Read more
In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety profile similar to placebo in young children ages 6 months through 4 years in Phase 2/3 clinical trial Pfizer-BioNTech COVID-19 Vaccine now authorized in the U.S. for all individuals 6 months of age and older Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today...Read more
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the U.S. Food and Drug Administration (FDA) expanded emergency use authorization (EUA) to include a booster dose after completion of the primary series of the Pfizer-BioNTech COVID-19 Vaccine in children 5 through 11 years of age. The booster dose is given at least five months after the second dose of the two-dose primary series and is the same 10-µg dose of the...Read more
50 µg dose approved for all adults over 50 years of age and immunocompromised adults over 18 years of age Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for its amendment to the emergency use authorization (EUA) to allow for a second booster dose of its COVID-19 vaccine...Read more
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) has expanded the emergency use of their COVID-19 vaccine to include a second booster dose in adults ages 50 years and older who have previously received a first booster of any authorized COVID-19 vaccine. The FDA also has authorized a second booster dose for individuals 12 years of age and older who have been determined to...Read more
Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"), developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to announce the submission of its U.S. Food & Drug Administration's (FDA) Emergency Use Authorization (EUA) application for its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test for Point of Care...Read more
Submission based on real-world safety and efficacy data from Israel Data showed rates of confirmed infections were 2 times lower and rates of severe illness were 4 times lower among individuals who received an additional booster dose of Pfizer-BioNTech COVID-19 Vaccine compared to individuals who received only an initial booster Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the companies have submitted an...Read more
Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"), developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to announce its AcuVid™ COVID-19 Rapid Antigen Saliva Test for Point of Care (PoC) has successfully exceeded U.S. Food & Drug Administration's (FDA) Emergency Use Authorization (EUA) requirements for both...Read more
AbCellera (Nasdaq: ABCL) today announced that bebtelovimab (LY-CoV1404), the second antibody developed through AbCellera’s collaboration with Eli Lilly and Company (Lilly), has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Bebtelovimab is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive...Read more
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today provided an update that the U.S. Food and Drug Administration (FDA) has notified the Company that it will require additional time to complete its assessment of Moderna’s Emergency Use Authorization (EUA) request for the use of the Moderna COVID-19 vaccine (mRNA-1273) at the 100 µg dose level in adolescents 12 to 17 years of...Read more
AbCellera (Nasdaq: ABCL) today announced the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for bamlanivimab (LY-CoV555) 700 mg administered with etesevimab (LY-CoV016) 1400 mg to include post-exposure prophylaxis (PEP) to prevent SARS-CoV-2 infection or symptomatic COVID-19. The neutralizing antibodies, which were authorized together by the FDA in February 2021 to treat early COVID-19 infection,...Read more
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the government of India has issued a registration certificate and a permission to import the COVID-19 Vaccine Moderna for restricted use in an emergency situation. “I want to thank the government of India for this authorization, which marks an important step forward in the global fight against the pandemic,”...Read more
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has requested an emergency use authorization (EUA) for its COVID-19 vaccine in adolescents with the U.S. Food and Drug Administration (FDA). “We are pleased to announce that we have submitted for an emergency use authorization for our COVID-19 vaccine with the FDA for use in adolescents in the United...Read more
Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce an update on the Company’s U.S. Food & Drug Administration (“FDA”) Phase 3 clinical trial (the “Study”) to evaluate the safety and efficacy of Bucillamine in patients with mild to moderate COVID-19. With its...Read more
Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce an update on the Company’s U.S. Food & Drug Administration (“FDA”) Phase 3 clinical trial (the “Study”) to evaluate the safety and efficacy of Bucillamine in patients with mild to moderate COVID-19. With its...Read more
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Qatar Ministry of Public Health has issued an emergency use authorization for COVID-19 Vaccine Moderna. “I want to thank the Qatar Ministry of Public Health for this authorization, which marks an important step forward in the global fight against COVID-19. We appreciate their continued confidence in our...Read more
AbCellera (Nasdaq: ABCL) today announced that bamlanivimab (LY-CoV555) 700 mg, a human antibody discovered by AbCellera and developed with Eli Lilly and Company (Lilly), administered with a second Lilly antibody, etesevimab (LY-CoV016) 1400 mg, has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for...Read more
ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...
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