Monday, May 19, 2025

Monday, May 19, 2025

Latest News

MEDICAL MARIJUANA, INC.: Announces International Coverage at FDA Public Hearing on Cannabis and CBD Products

Regulation

By Press release submission | Jun 4, 2019

Medical Marijuana, Inc. (OTC: MJNA) (the "Company"), the first-ever publicly traded cannabis company in the United Statesthat launched the world's first-ever cannabis-derived nutraceutical products, brands and supply chain, announced today that Dr. Stuart Titus, the Company's Chief Executive Officer, was featured in several national and international news publications about his speaking engagement at the U.S. Food and Drug Administration (FDA) Hearing on cannabis and cannabidiol (CBD) on Friday, May 31, 2019.

NANOVIRICIDES: Received Favorable FDA Comments on Its Pre-IND Application for the Lead Drug Candidate

FDA Approval

By Press release submission | Jun 3, 2019

NanoViricides, Inc. (NYSE American: NNVC) (the "Company") a company with novel platform technology to fulfill unmet medical needs in treating difficult and life-threatening viral diseases, reports that it has received favorable comments from the US FDA on the Company's pre-IND application for its lead drug candidate.

RESOLUTION BIOSCIENCE: Resolution Liquid Biopsy Assay Receives Breakthrough Device Designation from FDA

FDA Approval

By Press release submission | Jun 3, 2019

Accelerated pathway for companion diagnostic development granted to cell-free DNA assay for detecting HRD mutations and gene deletions

Bipartisan prescription drug price bill draws criticism from industry expert

By John Severance | Jun 1, 2019

How much is too much when it comes to the price of prescription drugs? This week, U.S. Senators John Cornyn (R-Texas) and Richard Blumenthal (D-Connecticut) crossed party lines and introduced a bill to answer that very question.

Doctor says stem cell providers not immune from legal action under proposed North Carolina law

FDA Approval

By John Severance | Jun 1, 2019

North Carolina passed a Right to Try law back in 2015 yet a bill introduced in April could expand that stem cell treatment law.

FDA Update: Which drugs are in short supply?

Drug Shortages

By FDA Reporter Submission | May 31, 2019

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.

Doctors disagree on FDA approach toward stem cell treatments

FDA Approval

By John Severance | May 31, 2019

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.

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

FDA Approval

By Press release submission | May 31, 2019

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.

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

FDA Approval

By Press release submission | May 31, 2019

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

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

FDA Approval

By Press release submission | May 31, 2019

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.

MEDIVIS: Wins FDA Clearance for Breakthrough Augmented Reality Surgical System

FDA Approval

By Press release submission | May 31, 2019

SurgicalAR™ Officially Brings Holographic Visualization into the Operating Room

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

FDA Approval

By Keri Carbaugh | May 30, 2019

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

Senate introduces health-care package with biosimilars boost

Reform

By Keri Carbaugh | May 30, 2019

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.

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

Regulation

By Press release submission | May 30, 2019

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.

U.S. FOOD AND DRUG ADMINISTRATION: Statement on FDA’s request for information on requiring fixed-quantity blister packaging for certain opioid pain medicines to help decrease unnecessary exposure to opioids

Regulation

By Press release submission | May 30, 2019

The opioid tragedy has become one of the defining public health crises of modern times.

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

FDA Approval

By John Suayan | May 29, 2019

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.

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

FDA Approval

By Press release submission | May 29, 2019

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).

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

FDA Approval

By Press release submission | May 29, 2019

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

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

FDA Approval

By Press release submission | May 28, 2019

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

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

FDA Approval

By Press release submission | May 28, 2019

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.

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FDA Reporter