FDA Archives - Page 10 of 220

4 minute read

Abbott Receives FDA Approval For TriClip, First-Of-Its-Kind Device To Repair Leaky Tricuspid Heart Valve

April 2, 9:01 AM

TriClip offers a remarkably safe, minimally invasive treatment option for patients in need of tricuspid valve repair but who are unable to withstand surgeryMore than 1.6 million people in the U.S. are affected by

ABT

2 minute read

Medical Devices Giant Baxter Secures FDA Approval For New Infusion Pump System

By Vandana Singh

April 1, 12:38 PM

FDA clears Baxter's Novum IQ LVP & SYR infusion pumps with Dose IQ Safety Software, streamlining training & reducing cognitive burden. Explore enhanced safety features & EMR interoperability.

BAX

2 minute read

FDA Presses Delay Button For Applied Therapeutics’ First Potential Marketed Drug For Rare Disease

By Vandana Singh

April 1, 12:30 PM

FDA extends the review period for Applied Therapeutics' NDA for govorestat, targeting Classic Galactosemia treatment. The new action date is set for November 28, 2024. Applied Therapeutics anticipates a decision from EMA in Q4 2024.

APLT

2 minute read

Abbott Receives FDA Clearance For Whole Blood Rapid Test To Help With Assessment Of Concussion At The Patient’s Bedside

By Benzinga Newsdesk

April 1, 9:01 AM

The test, run on Abbott's portable i-STAT® Alinity® instrument, uses whole blood to help evaluate patients with a suspected mild traumatic brain injury (mTBI), or concussionThe test produces lab-quality results

ABT

2 minute read

Bristol Myers Squibb Announces Pivotal KRYSTAL-12 Confirmatory Trial Evaluating KRAZATI Meets Primary Endpoint Of Progression-Free Survival For Patients With Pretreated KRASG12C-Mutated Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

By Benzinga Newsdesk

March 28, 4:12 PM

Bristol Myers Squibb Announces Pivotal KRYSTAL-12 Confirmatory Trial Evaluating KRAZATI (adagrasib) Meets Primary Endpoint of Progression-Free Survival for Patients with Pretreated KRASG12C-Mutated Locally Advanced or

BMY

2 minute read

4D Molecular Therapeutics Outlines Pivotal Development Plans For Cystic Fibrosis, Rare Inherited Disease

By Vandana Singh

March 28, 2:04 PM

4D Molecular Therapeutics' latest advancements in CF treatment. Get insights into their 4D-710 aerosolized genetic medicine for cystic fibrosis lung disease, including Phase 1/2 AEROW trial updates and Phase 3 clinical trial preparations.

FDMT

1 minute read

FDA Approves For Akebia Therapeutics’ Vafseo For Kidney Disease Associated Anemia

By Vandana Singh

March 28, 9:50 AM

The FDA-approved Vafseo tablets by Akebia Therapeutics for managing anemia in adult dialysis patients with chronic kidney disease. Learn about its once-daily oral HIF-PH inhibitor and global approval in 37 countries.

AKBA

1 minute read

Neurocrine Biosciences Announces Initiation Of Phase 1 Clinical Study Evaluating Effects Of NBI-1065890, A Second-Generation VMAT2 Inhibitor, In Healthy Adults

By Benzinga Newsdesk

March 28, 8:34 AM

Neurocrine Biosciences, Inc. (NASDAQ:NBIX), today announced the initiation of its Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound

NBIX

2 minute read

Medtronic’s Latest Generation Of Transcatheter Aortic Valve Replacement Implant Passes FDA’s Muster, Shares Gain

By Vandana Singh

March 27, 2:14 PM

FDA approves Medtronic's Evolut FX+ TAVR system for severe aortic stenosis. Enhanced coronary access, maneuverability for diverse anatomies. Early Commercial Experience in spring 2024.

MDT

2 minute read

The Most Important Catalyst For Merck’s Stock In 2024 Could Be Sotatercept Launch, Analyst Says

By Vandana Singh

March 27, 1:37 PM

Cantor Fitzgerald notes Merck's robust stock performance, up 15% YTD vs S&P 500's 10%.Potential peak sales projections ranging from $1 billion to $8 billion. Merck targets 40,000 potential patients.

MRK