FDA Archives - Page 101 of 220

5 minute read

U.S. FDA Broadens Indication For Verzenio In HR+, HER2-, Node-Positive, High Risk Early Breast Cancer

March 3, 4:05 PM

High risk patients eligible for Verzenio can now be identified solely based on nodal status, tumor size, and tumor grade, regardless of Ki-67 score Approval supported by four-year data

LLY

1 minute read

Why Veru Stock Is Crashing Today?

By Vandana Singh

March 3, 10:27 AM

The FDA declined to grant Veru Inc’s (NASDAQ:VERU) request for Emergency Use Authorization (EUA) for sabizabulin to treat hospitalized adult patients…

VERU

1 minute read

Despite Trial Failure Praxis Still Seeks Advancing Essential Tremor Program Into Phase 3 Study

By Vandana Singh

March 3, 10:05 AM

Praxis Precision Medicines Inc (NASDAQ:PRAX) announced topline results from the Essential1 study evaluating the efficacy, safety, and tolerability of ulixacaltamide (PRAX-944)…

PRAX

2 minute read

Galectin Therapeutics Provides Final Randomization Status Of NAVIGATE, Its Seamless, Adaptive Phase 2b/3 Study of Belapectin In Patients With Liver Cirrhosis Caused By Non-Alcoholic Steatohepatitis

By Happy Mohamed

March 2, 9:27 AM

Galectin Therapeutics, Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin-3, announced that in late December 2022, it ended the enrollment of new patients into NAVIGATE, its

GALT

2 minute read

BioVie Announces Completion Of Patient Enrollment In Phase 3 Trial Assessing NE3107 In Alzheimer’s Disease

By Happy Mohamed

March 2, 9:25 AM

BioVie Inc. (NASDAQ:BIVI) ("BioVie" or the "Company"), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced

BIVI

1 minute read

FDA Fuels Respiratory Syncytial Virus Vaccine Race While Backing GSK’s Candidate Soon After Pfizer’s

By Vandana Singh

March 2, 7:15 AM

The FDA’s Vaccines and Related Biological Products Advisory Committee voted that GSK plc’s (NYSE:GSK) available data support the safety and effectiveness of…

GSK

1 minute read

FDA
News

INOVIO Says Phase 2 REVEAL2 Trial Evaluating VGX-3100 Did Not Meet Primary Endpoint

By Benzinga Newsdesk

March 1, 6:15 PM

Announces topline results from REVEAL2, the second Phase 3 trial evaluating VGX-3100 as a treatment for cervical high-grade squamous intraepithelial lesions (HSIL) Trial results did not meet the primary endpoint in

INO

2 minute read

FDA Takes Action To Restrict Unlawful Import Of Animal Tranquilizer ‘Tranq’ Or ”Zombie Drug’

By Vandana Singh

March 1, 2:24 PM

The FDA issued an “import alert” about the animal tranquilizer xylazine, also called “tranq,” “tranq dope,” and “zombie drug.” The…

BBH

1 minute read

FDA AdComm Gives Thumbs Up To Pfizer’s RSV Vaccine Candidate For Elderly People

By Vandana Singh

March 1, 11:36 AM

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in favor of Pfizer Inc’s (NYSE:PFE) available data is adequate to…

PFE

1 minute read

FDA Rejects Cytokinetics’ Heart Failure Treatment Candidate

By Vandana Singh

March 1, 11:34 AM

The FDA issued a Complete Response Letter to Cytokinetics Incorporated’s (NASDAQ:CYTK) omecamtiv mecarbil, an investigational, selective, small molecule cardiac myosin activator, for…

CYTK