FDA Archives - Page 81 of 220

1 minute read

FDA Approves Roche’s Polivy Combo Therapy For Untreated Patients With Diffuse Large B-Cell Lymphoma

April 20, 9:53 AM

The FDA has approved Roche Group AG’s (OTC:RHHBY) Genentech’s Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) for…

RHHBF

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BioVie To Present Data From NE3107 Phase 2 Open-Label Trial At Society Of Biological Psychiatry Annual Meeting

By Benzinga Newsdesk

April 20, 8:50 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 liver

BIVI

2 minute read

Salarius Pharmaceuticals Presents Compelling Data In Two SP-3164 Targeted Protein Degrader Posters At The American Association For Cancer Research Annual Meeting

By Benzinga Newsdesk

April 20, 8:47 AM

SP-3164 demonstrates compelling antitumor activity in animal models of follicular lymphoma and compelling antitumor activity in animal models of multiple myelomaPreclinical findings support the Company's planned clinical

SLRX

3 minute read

ContraFect Data Presentations At The 33rd Annual ECCMID Meeting Highlight The Potential Efficacy Of Lysin CF-370 Against Antibiotic Resistant Gram-Negative Pathogens

By Benzinga Newsdesk

April 20, 8:47 AM

ContraFect Corporation (NASDAQ:CFRX), a clinical-stage biotechnology company focused on the discovery and development of direct lytic agents (DLAs), including lysins and amurin peptides, as new medical modalities for the

CFRX

4 minute read

SELLAS Life Sciences Successfully Completes Phase I Trial Dose Escalation Of Novel, Highly Selective CDK9 Inhibitor GFH009 In Acute Myeloid Leukemia

By Benzinga Newsdesk

April 20, 8:41 AM

– GFH009 showed strong anti-tumor effect and clinical and biological efficacy; PK profile supports anticipated once weekly dosing – – GFH009 demonstrated a favorable tolerability profile with no dose limiting

SLS

3 minute read

Catalyst Pharmaceuticals Announces Third-Party Abstracts On FYCOMPA® To Be Presented At The Upcoming American Academy Of Neurology 2023 Annual Meeting

By Benzinga Newsdesk

April 20, 8:33 AM

Catalyst Pharmaceuticals, Inc. ("Catalyst") (NASDAQ:CPRX), a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing and commercializing novel high-quality medicines for patients

CPRX

1 minute read

Precision BioSciences To Present Preclinical In Vivo Gene Editing Research For Its ARCUS HBV Program At Upcoming Global Hepatitis Summit 2023

By Benzinga Newsdesk

April 20, 8:11 AM

- Oral Presentation to Highlight Efficacy and Specificity of ARCUS Nucleases for Potential Treatment of Chronic Hepatitis BPrecision BioSciences, Inc. (NASDAQ:DTIL), a clinical stage gene editing company developing

DTIL

3 minute read

IceCure’s ProSense System Used In Endometriosis Cryoablation Study That Demonstrated Efficacy Rate Of 92.8% To Avoid Secondary Surgery

By Benzinga Newsdesk

April 20, 8:08 AM

ProSense System among the two types of systems used in the studyPain-free survival rates of 93.75% at 6 months and 82.72% at 36 months post-procedure190 million women globally live with endometriosis, for which there is

ICCM

2 minute read

Cantex And Michigan Medicine Announce Initiation Of A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Clinical Study To Determine The Safety And Efficacy Of Azeliragon In The Treatment Of Patients Hospitalized For COVID-19

By Benzinga Newsdesk

April 20, 8:07 AM

Cantex Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions, and Michigan Medicine, a part of the

VTVT

2 minute read

Reported April 19, Bright Minds Biosciences Receives A Favorable Written Opinion From The International Searching Authority For BMB-202

By Benzinga Newsdesk

April 20, 12:44 AM

-- BMB-202 is a highly selective 5-HT2A agonist that exhibits a more than 30-fold selectivity over 5-HT2C and more than 500-fold selectivity over 5-HT2B -- -- BMB-202 is the first clinical candidate from an

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