FDA Archives - Page 193 of 220

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FDA
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Pfizer And Biontech Submit Application To FDA For Emergency Use Authorization Of Omicron Ba.4/ba.5-Adapted Bivalent Covid-19 Vaccine

August 22, 10:37 AM

Data support request for Emergency Use Authorization of a 30-µg booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older Companies have rapidly scaled

BNTX

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FDA
News

UK Says Under The Approach, Eligible People Will Be Offered 0.1ml Dose Of Smallpox Jynneos Vaccine, Instead Of 0.5ml Dose Typically Administered

By Benzinga Newsdesk

August 22, 10:29 AM

-Reuters

EWU

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UK Says Monkeypox Vaccines To Be Piloted In Smaller But ‘Equally Effective’ Doses

By Benzinga Newsdesk

August 22, 10:19 AM

-Reuters

AEMD

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FDA
News

‘Latest Polio Outbreak Reveals Rare Risk of Oral Vaccine’ -NBC New York Report

By Benzinga Newsdesk

August 22, 9:37 AM

https://www.nbcnewyork.com/news/national-international/us-polio-outbreak-linked-to-the-oral-vaccine-revealing-its-risks/3833258/?_osource=SocialFlowTwt_NYBrand

SNY

3 minute read

Salarius Pharmaceuticals Adds Two Mayo Clinic Sites To Its Ongoing Phase 1/2 Trial Of Seclidemstat As A Treatment For Ewing’s Sarcoma And FET-Rearranged Sarcomas

By Bill Haddad

August 22, 8:33 AM

Expands Trial to 17 U.S. Sites and 25 Locations Initiation of All Anticipated U.S. Trial Sites Largely Completed HOUSTON, Aug. 22, 2022 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (NASDAQ:SLRX), a

SLRX

2 minute read

Kronos Bio Announces First Patient Dosed In Phase 1b/2 Clinical Trial Of Lanraplenib In Combination With Gilteritinib In Acute Myeloid Leukemia

By Bill Haddad

August 22, 8:08 AM

Kronos Bio, Inc. (NASDAQ:KRON), a company dedicated to transforming the lives of those affected by cancer, today announced that the first patient has been dosed in a Phase 1b/2 clinical trial of lanraplenib in

KRON

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Minerva Neurosciences Submits New Drug Application To FDA For Roluperidone For Treatment Of Negative Symptoms In Patients With Schizophrenia

By Bill Haddad

August 22, 8:01 AM

Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that the company has

NERV

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FDA Clears Insulet’s Omnipod 5 Automated Insulin Delivery System For Preschool Children

By Ragothaman Srinivasan

August 22, 7:39 AM

The U.S. Food and Drug Administration (FDA) has announced clearance to Insulet’s (NASDAQ: PODD) Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged two years and older with type 1 diabetes (T1D).

PODD

2 minute read

Travere Therapeutics And CSL Vifor Announce EMA Has Accepted For Review The Conditional Marketing Authorization Application For Sparsentan For The Treatment Of IgA Nephropathy

By Benzinga Newsdesk

August 22, 7:11 AM

Travere Therapeutics, Inc. (NASDAQ:TVTX) and CSL Vifor today announced that the EMA has accepted for review the Conditional Marketing Authorization (CMA) application for sparsentan for the treatment of IgAN, a rare

TVTX

1 minute read

Moderna To Supply 12M Doses Of Omicron-Containing Bivalent COVID-19 Booster Vaccines To The Government Of Canada

By Benzinga Newsdesk

August 22, 7:01 AM

Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Government of Canada has exercised its option to purchase an additional 4.5 million

MRNA