FDA Archives - Page 178 of 220

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for aTyr Pharma’s (NASDAQ: LIFE) lead therapeutic candidate, efzofitimod, for the treatment of systemic sclerosis (SSc)-associated, interstitial lung disease (ILD).

LIFE

1 minute read

Oramed Reports Top-Line Results From Phase 2 NASH Trial With Its ORMD-0801, Oral Insulin Candidate; Met Primary And Secondary Endpoint

By Bill Haddad

September 13, 8:46 AM

Primary endpoint met: ORMD-0801 was safe and well tolerated Secondary endpoint met: ORMD-0801 showed clinically meaningful reduction of liver fat from baseline at 12 weeks Strong evidence for treatment of NASH using

ORMP

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Nuvectis Pharma Announces Data for NXP800 In A Preclinical Model Of ARID1a-Mutated Gastric Carcinoma

By Benzinga Newsdesk

September 13, 8:32 AM

FORT LEE, N.J., Sept. 13, 2022 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. ("Nuvectis", "Company"), a biopharmaceutical company focused on the development of innovative precision medicines for the

NVCT

1 minute read

Pardes Biosciences Announces Commencement Of Phase 2 Trial Evaluating PBI-0451 For The Treatment Of SARS-CoV-2 Infections

By Benzinga Newsdesk

September 13, 8:04 AM

Phase 2 trial expected to enroll 210 patients at approximately 75 sites to evaluate antiviral activity, safety, and efficacy of PBI-0451 versus placebo Interim data from Phase 2 anticipated in Q1 2023

PRDS

2 minute read

aTyr Pharma Receives FDA Fast Track Designation For Efzofitimod For Treatment Of Systemic Sclerosis-Associated Interstitial Lung Disease

By Benzinga Newsdesk

September 13, 8:01 AM

aTyr Pharma, Inc. (NASDAQ:LIFE), a clinical stage biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced that the U.S.

LIFE