FDA Archives - Page 12 of 220

6 minute read

Iovance’s AMTAGVI Receives U.S. FDA Accelerated Approval For Advanced Melanoma

February 16, 4:22 PM

AMTAGVI is the first FDA-approved T cell therapy for a solid tumor cancer and first treatment option for advanced melanoma after anti-PD-1 and targeted therapy AMTAGVI deploys patient-specific immune cells that

IOVA

3 minute read

Cybin Inc. Q3 Earnings: Clinical Advances Amid Financial Loss

By The Dales Report

February 16, 3:07 PM

The TDR Three Key Takeaways:

CYBN

2 minute read

FDA Fast-Tracks Review Of Sarepta’s Groundbreaking Muscular Dystrophy Treatment With $1B Market In Sight

By Vandana Singh

February 16, 2:07 PM

Sarepta's Elevidys efficacy supplement accepted for Duchenne muscular dystrophy treatment expansion, potential $1 billion yearly opportunity. FDA review goal: June 21, 2024.

RHHBY

2 minute read

Why Is Gilead Sciences Stock Trading Lower Today?

By Vandana Singh

February 16, 1:50 PM

Gilead Sciences' global enrollment pause in magrolimab solid tumor studies. FDA issues partial clinical hold. Explore the impact on ongoing trials.

GILD

6 minute read

Novartis Announces The FDA Has Approved Xolair As First And Only Medicine For Children And Adults With One Or More Food Allergies

By Benzinga Newsdesk

February 16, 12:28 PM

Approval is based on data from the NIH-sponsored Phase III OUtMATCH study, which showed a significantly higher proportion of food allergy patients as young as 1 year treated with Xolair could tolerate small amounts

NVS

2 minute read

Cardiology’s Quantum Leap: FDA’s Advisory Panel Gives Thumbs Up To Abbott’s Minimally Invasive Heart Valve Repair Device

By Vandana Singh

February 14, 1:47 PM

FDA panel confirms support (13-1) for Abbott Laboratories' TriClip TEER system in treating tricuspid regurgitation. Approval decision expected from FDA in 2024.

ABT

4 minute read

Atara Biotherapeutics Announces Submission Of Investigational New Drug Application For ATA3219 For Treatment Of Lupus Nephritis

By Benzinga Newsdesk

February 14, 10:03 AM

ATA3219 is an Allogeneic CAR T-Cell Therapy Targeting CD19+ B Cells to Potentially Address the Root Cause of Lupus Nephritis (LN)ATA3219 Is Designed to Combine the Natural Biology of Unedited T Cells and the Benefits of

ATRA

6 minute read

Ipsen’s Onivyde Regimen, A Potential New Standard-Of-Care First-Line Therapy In Metastatic Pancreatic Adenocarcinoma, Approved By FDA

By Benzinga Newsdesk

February 13, 5:50 PM

Approval based on Phase III NAPOLI 3 clinical trial in which Onivyde® regimen (NALIRIFOX) demonstrated statistically significant superiority and clinically meaningful improvements in overall survival and

IPSEY

3 minute read

Masimo Announces FDA-Cleared “Over-The-Counter” Fingertip Pulse Oximeter

By Benzinga Newsdesk

February 13, 10:07 AM

Masimo MightySat® Medical Provides Clinically Proven Masimo SET® Pulse Oximetry to Consumers for Medical Use Without a PrescriptionMasimo (NASDAQ:MASI) announced today FDA clearance of MightySat® Medical,

MASI

2 minute read

Tonix Pharmaceuticals Announces Engagement Of Rho As CRO To Support Submission Of New Drug Application To The FDA For Approval Of Tonmya For The Management Of Fibromyalgia

By Benzinga Newsdesk

February 13, 9:12 AM

Tonmya™ is a potential new first-line therapy, non-opioid analgesic for the management of fibromyalgia, supported by statistically significant results from two Phase 3 trials New Drug Application (NDA)

TNXP