Wednesday, April 24, 2024

Wednesday, April 24, 2024

Latest News

SOLITON, INC.: Receives FDA 510(k) Clearance of its Acoustic Shockwave RAP Device

Soliton, Inc., (Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center ("MD Anderson"), announced that it has received clearance from the U.S. Food & Drug Administration ("FDA") to market its Rapid Acoustic Pulse ("RAP") device for tattoo removal.

NOVADOZ PHARMACEUTICALS: MSN Labs/Novadoz Pharmaceuticals receives consecutive FDA approvals for their generic versions of Solifenacin and Trientine

It was a very significant week for Novadoz Pharmaceuticals, the U.S sales & marketing affiliate of The MSN Group (MSN) based in Hyderabad, India.

COTA, INC.: Signs Research Collaboration Agreement With The U.S. Food and Drug Administration

Collaboration Aims to Study Variation in Cancer Treatment Patterns by Extracting and Analyzing Real-World Data

INOVA DIAGNOSTICS: QUANTA Flash RF IgM and IgA receive FDA clearance

Inova Diagnostics, a world leader in autoimmune disease diagnostic systems and reagents for the clinical laboratory, is pleased to announce the 510(k) clearance of QUANTA Flash® Rheumatoid Factor (RF) IgM and QUANTA Flash RF IgA assays by the US Food and Drug Administration (FDA).

Iowa congressman praises FDA's decision to extradite treatment for woman battling rare form of ALS

U.S. Rep. Steve King (R-Iowa) praised the Food and Drug Administration for its decision to speed up treatment for a 25-year-old Iowa woman battling amyotrophic lateral sclerosis, or Lou Gehrig’s disease.

NUTEK FOOD SCIENCE: To Transition Potassium Salt Labeling Initiative to New FDA Docket

NuTek Food Science, LLC, a company that helps create great-tasting and affordable foods to enhance global health and wellness, announced that it is withdrawing its widely supported and highly publicized citizen petition concerning potassium salt that was filed with the FDA in 2016.

Senate introduces health-care package with biosimilars boost

Bipartisan draft legislation was presented by the Senate Committee on Health, Education, Labor and Pensions (HELP) and chairman Lamar Alexander (R-TN) and Patty Murray (D-WA) that includes proposals featuring the use of biosimilars to lower health care costs.

New gene therapy to be world’s most expensive drug at $2.1M

Zolgensma, a gene therapy to treat spinal muscular atrophy (SMA) in infants, will be the world’s most expensive drug at $2.1 million.

MEDIVIS: Wins FDA Clearance for Breakthrough Augmented Reality Surgical System

SurgicalAR™ Officially Brings Holographic Visualization into the Operating Room

LUYE PHARMA: Luye Pharma's Rykindo® NDA Filing Accepted by the U.S. FDA

Rykindo® (LY03004), Luye Pharma's innovative, independently developed Extended-Release Microspheres formulation for injection, is one step closer to going on the U.S. market.

CEPHEID: Receives FDA Clearance for Extragenital Claims for Xpert® CT/NG Test

On-Demand Same-Day Extragenital Testing for Chlamydia and Gonorrhea Fills Critical Unmet Need in Fight Against Rising Rates of Chlamydial and Gonorrheal Infection

LEICA BIOSYSTEMS: Receives FDA 510(k) Clearance to Market a Digital Pathology System for Primary Diagnosis

Leica Biosystems, the global leader in pathology workflow solutions, announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Aperio AT2 DX System for clinical diagnosis in the U.S.

Doctors disagree on FDA approach toward stem cell treatments

WASHINGTON -- The New York Times recently published a lengthy story about stem cell treatments, describing the Food and Drug Administration’s approach as industry friendly.

FDA Update: Which drugs are in short supply?

The Food and Drug Administration this week updated its list of which drugs are in short supply in the nation and which previous drug shortages have been resolved.

FDA Reporter