Thursday, September 19, 2019

Thursday, September 19, 2019

Latest News

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

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

Bipartisan prescription drug price bill draws criticism from industry expert

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.

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

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

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

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.

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

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.

U.S. FOOD AND DRUG ADMINISTRATION: Federal court issues decision holding that US Stem Cell clinics and owner adulterated and misbranded stem cell products in violation of the law

U.S. District Judge Ursula Ungaro of the Southern District of Florida granted the government’s motion for summary judgment against US Stem Cell Clinic LLC, of Weston, Florida, and US Stem Cell Inc., of Sunrise, Florida, and their Chief Scientific Officer Kristin Comella, Ph.D.

ZAVATION: Gains US FDA Clearance for the Ti3Z Interbody System (TLIF, T-PLIF, and PLIF)

Zavation, an employee-owned medical device company that designs, develops, manufactures and distributes medical device products, announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market the Ti3Z Interbody System (TLIF, T-PLIF, and PLIF).

FDA to host conference in London

The FDA Drug Approval Process conference in London will provide an overview of procedures and requirements for the U.S. drug approval process.

R3 Stem Cell receives letter from FDA over unapproved products

R3 Stem Cell and CEO David Green received an untitled letter from the Food and Drug Administration (FDA) for unapproved stem cell products offered at its more than 50 centers around the U.S.

AKONNI BIOSYSTEMS INC.: Receives FDA 510(k) Clearance of Its TruDiagnosis Multiplex Diagnostic System

FDA clearance is part of Company's three-part strategy to change the business paradigm for the molecular diagnostic industry

R3 STEM CELL: Responds to FDA Letter to Reaffirm its Commitment to Public Health and Safety

R3 Stem Cell, LLC (R3), a leader in regenerative therapy practices, issued a formal response to a letter it received from the FDA that raised concerns over alleged unapproved stem cell products to treat a variety of diseases and conditions as well as potential safety concerns.

FDA to shut down secret recording program

When the FDA made the announcement, it said it would open past records within weeks. So why did the FDA have such a policy and why was it secret?

TB ALLIANCE: FDA Advisory Committee Votes Favorably on the Question of the Effectiveness and Safety of Pretomanid in Combination with Bedaquiline and Linezolid for Treatment of Highly Drug-Resistant Forms of Tuberculosis

Investigational drug pretomanid, developed by non-profit TB Alliance, is under regulatory review for treatment of extensively drug-resistant tuberculosis and treatment-intolerant or non-responsive multidrug-resistant tuberculosis as part of a new investigational regimenthat includes bedaquiline and linezolid

NULEAF NATURALS: CBD Provider NuLeaf Naturals Appears before FDA in Support of Industry Regulation and Standards

On May 31, NuLeaf Naturals representative Crystal Guess was one of 140 individuals to testify in a groundbreaking public meeting called by the Food and Drug Administration (FDA).

FDA OK'd 481 drugs in May

The U.S. Food and Drug Administration approved 481 drug products in May, according to an online list the agency updated this week.

Right to Try legislation sits in North Carolina senate committee

North Carolina House Bill 934, which passed unanimously 114-0, was sent to the State Senate where it currently is in committee.

AIDOC: AI for C-Spine Fractures: Aidoc Sets the Pace With 3rd FDA Clearance in 9 Months

Aidoc's solution ensures patients with C-spine fractures are treated faster, saving lives

U.S. FOOD AND DRUG ADMINISTRATION: Statement on FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys

At the U.S. Food and Drug Administration, increasing our scientific knowledge and capabilities is a cornerstone to ensuring the safety of the foods that Americans consume.

FDA Reporter