FDA Archives - Page 5 of 220

2 minute read

CEL-SCI Receives FDA Approval For Its Confirmatory Study Of Multikine For The Treatment Of Head & Neck Cancer

May 8, 9:03 AM

Critical milestone achieved—the FDA accepted CEL-SCI's selection criteria defining the Multikine target population before surgerySelected patient population had 73% survival with Multikine vs. 45% without Multikine based

CVM

1 minute read

What About Eli Lilly’s Drug For Early Alzheimer’s? FDA Panel To Discuss Next Month

By Vandana Singh

May 7, 12:38 PM

FDA's advisory committee meeting on June 10, 2024, discussing Eli Lilly's donanemab for early Alzheimer's.

LLY

2 minute read

Merus Announces U.S. FDA Acceptance And Priority Review Of BLA For Zeno For The Treatment Of NRG1+ NSCLC And PDAC

By Benzinga Newsdesk

May 6, 4:28 PM

Merus N.V. (NASDAQ:MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced that the

MRUS

1 minute read

Why Outset Medical Shares Are Up Today

By Erica Kollmann

May 6, 2:40 PM

Outset said that it has resumed distribution of TabloCart with prefiltration and has product available to ship to customers in the United States.

2 minute read

Hormel Foods Recalls Some Contaminated Planters Nuts In Five States

By Vandana Singh

May 6, 1:46 PM

Hormel Foods recalls Planters products due to listeria contamination. Details on impacted items & distribution areas.

HRL

7 minute read

Johnson & Johnson Announces Phase 2 Data For ERLEADA Plus Androgen Deprivation Therapy Following Radical Prostatectomy In Patients With High-Risk Localized Prostate Cancer Show 100% Biochemical Free Recurrence Rate More Than Two Years Post-Surgery; Stu…

By Benzinga Newsdesk

May 3, 12:23 PM

Study highlights opportunity for treatment intensification in this population since approximately 50% of patients with high-risk localized prostate cancer (HRLPC) experience disease recurrence within two years of

JNJ

2 minute read

OrthoPediatrics Corp. Receives “Breakthrough Device” Designation From FDA For eLLi Growing Rod System For Pediatric Patients With Scoliosis

By Benzinga Newsdesk

May 2, 5:12 PM

OrthoPediatrics Corp. ("OrthoPediatrics") (NASDAQ:KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today announced it has received the "Breakthrough Device" Designation from the Food

KIDS

3 minute read

FDA
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Taysha Gene Therapies Announces Regenerative Medicine Advanced Therapy Designation Granted By U.S. FDA For TSHA-102 In Rett Syndrome

By Benzinga Newsdesk

May 2, 8:10 AM

RMAT designation follows FDA's review of available safety and efficacy data from the first three patients dosed with the low dose of TSHA-102 across both REVEAL Phase 1/2 trials (adolescent/adult and pediatric) RMAT

TSHA

2 minute read

FDA Approves X4 Pharmaceuticals’ Mavorixafor As First Therapy For Rare Immunodeficiency Disorder

By Vandana Singh

April 29, 12:10 PM

FDA approves Xolremdi capsules for WHIM syndrome, boosting neutrophil & lymphocyte counts. First therapy for this rare immunodeficiency disorder. Potential sales forecasted at $54.6M in 2024, rising to $450.9M by 2027.

XFOR

3 minute read

GE HealthCare Receives FDA Clearance For Portrait VSM, Building In Its Growing Ecosystem Of Connected Patient Monitoring Solutions

By Benzinga Newsdesk

April 29, 9:13 AM

The portable vital signs monitor (VSM) adds to GE HealthCare's growing Portrait Ecosystem to help clinicians make timely treatment decisions and detect patient deterioration earlier with a streamlined spot check

GEHC