FDA Reporter News

By Press release submission | Oct 7, 2020

SentiAR, a pioneer in visualization technologies for surgical applications announces U.S. Food and Drug Administration (FDA) 510(k) clearance of its groundbreaking CommandEP™ system, the first holographic guidance system to be used during an invasive cardiac procedure.

INOVIO: Reports FDA Partial Clinical Hold for Planned Phase 2 / 3 Trial of COVID-19 Vaccine Candidate INO-4800

By Press release submission | Oct 7, 2020

INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, announced that the U.S. Food and Drug Administration (FDA) has notified the company it has additional questions about the company's planned Phase 2/3 trial of its COVID-19 vaccine candidate INO-4800, including its CELLECTRA® 2000 delivery device to be used in the trial. Until the FDA's questions have been satisfactorily addressed, INOVIO's Investigational New Drug Application (IND) for the Phase 2/3 trial is on partial clinical hold.

STEMEDICA CELL TECHNOLOGIES, INC.: FDA Grants IND Approval for Phase II Clinical Trial Using Stemedica's itMSC Therapy for COVID-19 Patients

By Press release submission | Oct 6, 2020

Stemedica Cell Technologies, Inc. has received U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) approval for "A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Intravenous Allogeneic Mesenchymal Stem Cells in Patients with Moderate to Severe Lung Injury due to COVID-19."

USDA and FDA Sign Memorandum of Understanding to Enhance Collaboration, Efficiency on U.S. Dairy Exports

By Press release submission | Oct 5, 2020

The United States Department of Agriculture (USDA) and the United States Food and Drug Administration (FDA) signed a Memorandum of Understanding (MOU) outlining strengthened coordination between the FDA and the USDA’s Agricultural Marketing Service (AMS) and Foreign Agricultural Service (FAS) to facilitate the export of milk and milk products from the United States. U.S. dairy exports are valued at nearly $6 billion annually.

FDA: Issues Final Guidance for Certain Labeling Recommendations for Breast Implants

By Press release submission | Oct 5, 2020

The U.S. Food and Drug Administration issued the final guidance, “Breast Implants - Certain Labeling Recommendations to Improve Patient Communication,” as part of the agency’s effort to help improve the information available to patients and health care professionals about the risks of breast implants.

REMEGEN: Announces US FDA Has Granted Breakthrough Therapy Designation for Disitamab Vedotin (RC48) in Urothelial Cancer

By Press release submission | Sep 27, 2020

The Breakthrough Therapy designation marks an important milestone for RemeGen's leading ADC treatment for urothelial cancer

BIOVICA: Completes 510(k) submission for DiviTum®TKa to the FDA

By Press release submission | Sep 27, 2020

Biovica, active in blood-based cancer diagnostics, today announced that the company has filed a 510(k) submission with the U.S. Food and Drug Administration (FDA).

BAUSCH HEALTH COMPANIES INC.: FDA Approves Bausch + Lomb Alaway® Preservative Free (Ketotifen Fumarate) Ophthalmic Solution, 0.035%

By Press release submission | Sep 26, 2020

First OTC Preservative-Free Eye Drop Approved for the Treatment of Itchy Eyes Associated with Allergies. Provides Up to 12 Hours of Eye Itch Relief

NEUROPHTH THERAPEUTICS: Treatment of Leber's Hereditary Optic Neuropathy Gene Therapy NR082 was Granted Orphan Drug Designation by U.S. FDA

By Press release submission | Sep 26, 2020

Neurophth Therapeutics, Inc., (hereinafter referred to as "Neurophth") today announced that its leading candidate, NR082 (rAAV2-ND4, NFS-01 project), was granted an orphan drug designation (ODD) by the U.S. FDA for the treatment of Leber's Hereditary Optic Neuropathy associated with ND4 mutation.

CONSUMERS FOR DENTAL CHOICE: Consumer, medical, environmental, parent groups praise FDA recommendations against amalgam for children, pregnant women, and other vulnerable populations

By Press release submission | Sep 26, 2020

Consumers for Dental Choice issued the following announcement on September 24.A broad array of consumer, medical, parents, and environmental groups are lauding a new safety communication from the U.S.

GENSCRIPT PROBIO: Congratulates XLifeSc on FDA Allowance of IND Application for TCR-T Program

By Press release submission | Sep 25, 2020

On September 24, XiangXue Life Sciences (XLifeSc), a partner of GenScript ProBio, announces FDA allowance of its IND application for TCR-T program (TCRT-ESO-A2). GenScript ProBio extends congratulations on this.

AKERO THERAPEUTICS: To Continue Efruxifermin Development With Innovative Adaptive Phase 2b/3 Clinical Trial Design Based On FDA Written Guidance

By Press release submission | Sep 25, 2020

Therapeutics, Inc. (Nasdaq: AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, today announced that written guidance from the U.S. Food and Drug Administration (FDA) enables the company to implement an innovative combined Phase 2b/3 study design for pivotal efruxifermin (EFX) trials in NASH patients.

CAPSOVISION INC.: Announces FDA Enforcement Discretion for At-Home Capsule Endoscopy Administration of CapsoCam Plus during COVID-19

By Press release submission | Sep 25, 2020

CapsoVision, an innovator in the gastroenterology diagnostics market, announced that the U.S Food & Drug Administration (FDA) will apply enforcement discretion which allows at-home administration of the CapsoCam Plus® small bowel capsule endoscope during the COVID-19 pandemic for patients who are determined eligible for at-home administration.

FDA: Achieves Key Milestone, Finalizes Framework That Will Resume Shellfish Trade with Europe for the First Time in 10 Years

By Press release submission | Sep 23, 2020

U.S. Food and Drug Administration finalized a molluscan shellfish equivalence determination for two European Union (EU) Member States, Spain and the Netherlands.

FDA: Clarifies Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products

By Press release submission | Sep 22, 2020

We proposed updates to our regulations to clarify the types of evidence the FDA considers when determining the “intended use” of a product.

FDA: Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests

By Press release submission | Sep 20, 2020

The U.S. Food and Drug Administration published comparative performance data for some authorized COVID-19 molecular diagnostic tests.

FDA: Provides Guidance to Industry for Detecting and Preventing Nitrosamines in Drugs

By Press release submission | Sep 4, 2020

The following is attributed to FDA Commissioner Stephen M. Hahn, M.D., and Patrizia Cavazzoni, M.D., acting director, Center for Drug Evaluation and Research

FDA: Announces Advisory Committee Meeting to Discuss COVID-19 Vaccines

By Press release submission | Aug 30, 2020

The U.S. Food and Drug Administration announced that a public meeting of the Vaccines and Related Biological Products Advisory Committee will be held on Oct. 22, 2020, to discuss the general matter of the development, authorization, and/or licensure of vaccines indicated to prevent COVID-19.

JOINTECHLABS: FDA Clears Jointechlabs' MiniTC for Point-of-Care Fat Tissue Processing and its Broad Range of Applications