FDA Archives - Page 217 of 220

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Co-Diagnostics Announces Shipment Of Monkeypox Virus Test

July 11, 9:30 AM

Co-Diagnostics, Inc. (NASDAQ:CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that

CODX

3 minute read

FDA
News

T2 Biosystems Receives FDA Breakthrough Device Designation For T2Lyme Panel

By Benzinga Newsdesk

July 11, 8:02 AM

T2 Biosystems, Inc. (NASDAQ:TTOO) a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device

TTOO

1 minute read

FDA Clears LPCN 2101 IND For Adult Epilepsy Treatment

By Bill Haddad

July 11, 8:00 AM

Lipocine Inc. (NASDAQ:LPCN), a biopharmaceutical company focused on developing innovative products to treat metabolic and central nervous system ("CNS") disorders with high unmet medical needs, announced

LPCN

2 minute read

Can-Fite To Submit FDA & EMA Registration Plans For Piclidenoson In The Oral Treatment Of Moderate To Severe Psoriasis

By Bill Haddad

July 11, 7:02 AM

Further analysis of Phase III COMFORT™ data show Piclidenoson's superior safety profile and higher patient compliance compared to Otezla® Can-Fite BioPharma Ltd. (NYSE:CANF) (TASE: CFBI), a

CANF

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FDA
News

Nyxoah Received FDA IDE Approval to Initiate the ACCCESS Study of Genio in Complete Concentric Collapse Patients

By Charles Gross

July 11, 5:46 AM

Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ("Nyxoah" or the "Company"), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that the U.S.

NYXH

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FDA
News

Macrogenics Announces Closure Of CP-MGA271-06 Study Evaluating Enoblituzumab Plus Checkpoint Inhibition In Head And Neck Cancer; Shares Move Sharply Lower

By Benzinga Newsdesk

July 8, 4:33 PM

MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today announced that effective as of July 7,

MGNX

4 minute read

FDA
News

Apyx Medical Corporation Announces Results Of The U.S. Ide Clinical Study Evaluating The Use Of Renuvion To Improve The Appearance Of Lax Skin In The Neck And Submental Region; Says Primary Effectiveness Endpoint Of Study Was Met

By Benzinga Newsdesk

July 8, 3:54 PM

Apyx Medical Corporation (NASDAQ:APYX) (the "Company"), the manufacturer of a proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion®, today announced that the results of

APYX