Wednesday, April 2, 2025

Wednesday, April 2, 2025

Latest News

COHLEAR LIMITED: FDA approves new cochlear implant with easier access to MRI and expanded connectivity ready for Google's direct streaming to Android smartphones

FDA Approval

By Press release submission | Jun 17, 2019

Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, today announced the U.S. Food and Drug Administration's (FDA) approval of the new Cochlear™Nucleus® Profile™ Plus Series Cochlear Implant and the Nucleus 7 Sound Processor's new built-in connectivity featuring direct streaming with compatible Android™ smartphones.

HI-TECH PHARMACEUTICALS, INC.: The Government and FDA Ordered to Return Five Truckloads of DMAA to Hi-Tech Pharmaceuticals

Regulation

By Press release submission | Jun 15, 2019

Jared Wheat, CEO of Hi-Tech Pharmaceuticals, released the following statement in response to the return over $19 million worth of DMAA to Hi-Tech Pharmaceuticals

TRINETX: Applauds House Appropriations Committee for Supporting Use of Real-World Evidence in House Agriculture-FDA Spending Bill

Reform

By Press release submission | Jun 14, 2019

TriNetX, the global health research network that revolutionizes clinical research and enables discoveries through the generation of real-world evidence (RWE), praised the House Appropriations Committee for approving its fiscal year 2020 Agriculture, Rural Development, FDA, and Related Agencies bill which includes support for the use of RWE in regulatory decision making.

IBM, KPMG, Merck and Walmart to collaborate as part of FDA's program to evaluate the use of blockchain to protect pharmaceutical product integrity

Regulation

By Press release submission | Jun 14, 2019

The FDA pilot program explores innovative and emerging approaches for the tracing and verification of prescription products

ARATANA THERAPEUTICS: Granted FDA Approval of NOCITA® (bupivacaine liposome injectable suspension) 10 mL Vial

FDA Approval

By Press release submission | Jun 13, 2019

Commercial availability of NOCITA 10 mL vial size anticipated by fall 2019

EMCYTE CORPORATION: Announces FDA 510(k) Clearance for its PureBMC® Supraphysiologic Concentrating System

FDA Approval

By Press release submission | Jun 13, 2019

EmCyte, is proud to announce that it has received FDA 510(k) clearance for its PureBMC® Supraphysiologic Concentrating System.

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.

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

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

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

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

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.

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  3. 3 LOCATE BIO: CognitOss Granted FDA Breakthrough Device Designation
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