Sunday, May 4, 2025

Sunday, May 4, 2025

Latest News

METVITAL, INC.: Announces FDA Clearance of Investigational New Drug (IND) Application for AEO for Phase 2 testing for Glioblastoma Multiforme

FDA Approval

By Press release submission | Jun 12, 2019

MetVital, Inc., a biopharmaceutical company developing small molecule modulators of glutamate metabolism for the treatment of diseases with significant unmet medical need and commercial potential, announces that the U.S. Food and Drug Administration (FDA) has notified MetVital that it may proceed with its clinical investigation of "Anhydrous Enol-Oxaloacetate" (AEO) as a potential treatment for patients with Glioblastoma Multiforme.

CORMATRIX CARDIOVASCULAR, INC. receives FDA 510(k) clearance to market the Cor™ PATCH epicardial patch for tissue support and repair in adult patients

Patients

By Press release submission | Jun 12, 2019

CorMatrix® Cardiovascular, Inc. www.cormatrix.com, a leading developer of regenerative cardiovascular medical devices, announced FDA 510(k) clearance for the Cor™ PATCH. The Cor™ PATCH is indicated for epicardial tissue support and repair in adult patients.

Project Facilitate will help physicians access unapproved therapies

Reform

By Keri Carbaugh | Jun 12, 2019

A new pilot program, Project Facilitate, was announced last week by the Food and Drug Administration to help oncology health-care professionals access unapproved therapies for their cancer patients.

Hundreds of Thousands of Deaths a Year a 'Call to Action,' FDA Says on World Food Safety Day

Regulation

By Keri Carbaugh | Jun 11, 2019

The first World Food Safety Day was held on June 7 with deputy commissioner for food policy and response Frank Yiannas representing the Food and Drug Administration.

National Cannabis Industry Association urges FDA to regulate CBD

Regulation

By Angela Underwood | Jun 11, 2019

The National Cannabis Industry Association (NCIA) says the Federal Drug Administration (FDA) should take immediate steps to approve non-psychoactive cannabidiol components such as CBD for general use.

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

Regulation

By Press release submission | Jun 11, 2019

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.

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

FDA Approval

By Press release submission | Jun 11, 2019

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

DATA2LIFE: Data2Life's AI Powered RWE Platform Supports the CannaPharma Industry's Next Big Leap - Following FDA Concerns

Regulation

By Press release submission | Jun 10, 2019

Recent FDA hearing about CBD products emphasises the need for solid Real-Word Evidence Data

Right to Try legislation sits in North Carolina senate committee

Regulation

By John Severance | Jun 9, 2019

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

FDA OK'd 481 drugs in May

FDA Approval

By FDA Reporter Submission | Jun 7, 2019

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

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

Regulation

By Press release submission | Jun 7, 2019

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).

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

Regulation

By Press release submission | Jun 7, 2019

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

FDA to shut down secret recording program

Reform

By John Severance | Jun 6, 2019

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?

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

FDA Approval

By Press release submission | Jun 6, 2019

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.

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

FDA Approval

By Press release submission | Jun 6, 2019

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

R3 Stem Cell receives letter from FDA over unapproved products

FDA Approval

By Keri Carbaugh | Jun 5, 2019

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.

FDA to host conference in London

Reform

By Keri Carbaugh | Jun 5, 2019

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

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

FDA Approval

By Press release submission | Jun 5, 2019

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).

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

Regulation

By Press release submission | Jun 5, 2019

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.

W. L. GORE & ASSOCIATES: GORE® CARDIOFORM ASD Occluder Receives FDA Approval for the Treatment of Atrial Septal Defects

FDA Approval

By Press release submission | Jun 4, 2019

Data from the Gore ASSURED Clinical Study demonstrated 100 percent closure success at six months

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FDA Reporter