FDA Archives - Page 180 of 220

2 minute read

Mersana Therapeutics Announces FDA Fast Track Designation Granted To XMT-1660 For The Treatment Of Triple-Negative Breast Cancer

September 12, 8:20 AM

Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical

MRSN

3 minute read

NuCana Presents Data On NUC-3373 At The European Society Of Medical Oncology Annual Meeting 2022

By Benzinga Newsdesk

September 12, 8:10 AM

NUC-3373 Demonstrates Promising Anti-Tumor Activity and Safety in Combination with Oxaliplatin (NUFOX) and Irinotecan (NUFIRI) in Heavily Pre-Treated Colorectal Cancer Patients Randomized Study of NUFIRI vs.

NCNA

3 minute read

Onconova Therapeutics Announces Updated Data From Investigator-sponsored Phase 1/2a Trial Evaluating Rigosertib In Combination With Nivolumab In Advanced KRAS-Mutated Non-Small Cell Lung Cancer At The ESMO Congress 2022

By Bill Haddad

September 12, 8:04 AM

Data show an early signal of efficacy in an extensively pre-treated population with 1 complete response and 2 partial responses achieved in 14 evaluable patients Responses achieved in patients with 3

ONTX

1 minute read

Alector Initiates Phase 1 Clinical Trial Of AL044 For The Treatment Of Alzheimer’s Disease

By Benzinga Newsdesk

September 12, 7:12 AM

AL044 is the first clinical-stage drug candidate targeting MS4A, a major genetic risk factor for AD AL044, a novel first-in-class therapeutic candidate, seeks to counteract multiple AD pathologies through

ALEC

3 minute read

Allakos Announces Initiation Of Phase 2b Clinical Trial Of Subcutaneous Lirentelimab In Chronic Spontaneous Urticaria

By Benzinga Newsdesk

September 12, 7:04 AM

Allakos Inc. (NASDAQ:ALLK), a biotechnology company developing lirentelimab (AK002) and AK006 for the treatment of allergic and inflammatory diseases, today announced it has initiated a Phase 2b clinical trial to

ALLK

1 minute read

Can-Fite Reports New Phase III Psoriasis Data Showing Superior Safety & Improved Efficacy Presented By KOL Dr. Papp At The 31st European Academy Of Dermatology

By Benzinga Newsdesk

September 12, 7:02 AM

Dr. Papp: "The safety results on Piclidenoson and its progressive effectiveness over the study period position it as unique among the current treatment options especially given the chronic nature of psoriasis

CANF

1 minute read

Keros Therapeutics Presents Additional Clinical Data From Its KER-012 Program And Preclinical Data From Its KER-050 Program At The American Society Of Bone And Mineral Research 2022 Annual Meeting

By Benzinga Newsdesk

September 12, 6:01 AM

Keros Therapeutics, Inc. ("Keros") (NASDAQ:KROS), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from

KROS

1 minute read

Bristol Myers’ Deucravacitinib Scores FDA Approval For Plaque Psoriasis

By Vandana Singh

September 12, 6:00 AM

The FDA approved Bristol Myers Squibb Co’s (NYSE:BMY) Sotyktu (deucravacitinib), an allosteric tyrosine kinase 2 (TYK2) inhibitor, for moderate-to-severe plaque psoriasis…

AMGN

3 minute read

Important Biotech Catalysts For September 9, 2022 – End Of The Day Summary

By Ragothaman Srinivasan

September 9, 5:47 PM

The U.S. Food and Drug Administration (FDA) has approved Spectrum Pharmaceuticals’ (NASDAQ:SPPI) lead asset ROLVEDON (eflapegrastim-xnst) injection to…

ADAP

1 minute read

Spectrum Gets FDA Nod For Febrile Neutropenia Candidate, Sees Commercial Launch In Q4 2022

By Ragothaman Srinivasan

September 9, 4:57 PM

The U.S. Food and Drug Administration (FDA) has approved Spectrum Pharmaceuticals’ (NASDAQ: SPPI) lead asset ROLVEDON (eflapegrastim-xnst) injection to decrease the incidence of infection, as manifested by febrile neutropenia.

SPPI