Latest News

LUMINEX: Receives FDA Emergency Use Authorization for ARIES® SARS-CoV-2 Assay to Detect Virus Responsible for COVID-19 Disease

Luminex is now able to provide SARS-CoV-2 diagnostic tests for both high-complexity, high-throughput reference labs and moderate complexity, sample-to-answer testing facilities

IMSTEM BIOTECHNOLOGY: Announces FDA has Lifted the Clinical Hold on the Investigational New Drug Application for IMS001 for the Treatment of Multiple Sclerosis

ImStem Biotechnology, Inc. (Farmington CT), a biopharmaceutical company pioneering the development of human embryonic stem cell (ESC) derived mesenchymal stem cells (hES-MSC), through a proprietary method using a trophoblast intermediate stage (hence also known as T-MSC) for the treatment of neurological, autoimmune, and rare orphan diseases, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold and cleared the Investigational New Drug (IND) application to evaluate IMS001 for the treatment of multiple sclerosis (MS).

FDA: Coronavirus (COVID-19) Update: FDA Issues Guidance for Conducting Clinical Trials

The U.S. Food and Drug Administration today issued a guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic.

FDA: Works to Ensure Smooth Regulatory Transition of Insulin and Other Biological Products

Transition is Expected to Increase Patient Access and Potentially Lower Prices on Insulin

FDA: Takes Action with Indian Government to Protect Consumers From Illicit Medical Products

First Bilateral Enforcement Operation with India Stopped Approximately 500 Shipments Through International Mail

MEDICREA: Announces FDA Clearance of the World’s First Patient-Matched Spinal Interbody Cages

MEDICREA® (Euronext Growth Paris : FR0004178572 – ALMED, PEA-PME eligible and OTCQX : MRNTF), pioneering the transformation of spinal surgery through Artificial Intelligence, predictive modeling and patient specific implants with its UNiD® ASI (Adaptive Spine Intelligence) proprietary software platform, concierge expert services and technologies, announced today that it has received FDA-Clearance for UNiD® IB3D Patient-Matched interbody cages which completes its UNiD® ASI platform technology.

U.S. FDA: Statement on quality issues with certain Cardinal Health surgical gowns and packs

FDA working with manufacturer to assess scope of potential contamination risk, possible supply chain disruptions

U.S. FDA: Statement on National Academies of Sciences, Engineering, and Medicine report on framing opioid prescribing guidelines for acute pain

In August 2018, the U.S. Food and Drug Administration contracted the National Academies of Sciences, Engineering, and Medicine (NASEM) to help advance the development of evidence-based guidelines for opioid analgesic prescribing for acute pain resulting from specific conditions or procedures.

FDA plans 24 public meetings in November

The U.S. Food and Drug Administration (FDA) has scheduled 24 public meetings, conferences and workshops for November, the agency reported.

Mylan recalls anxiety medication Alprazolam

Mylan Pharmaceuticals Inc. is carrying out a voluntary nationwide recall of one lot of Alprazolam Tablets, USP C-IV 0.5 mg, due to the potential presence of a foreign substance.

BLUEWILLOW: Receives FDA Clearance to Begin Phase 1 Study of its Intranasal Anthrax Vaccine

BlueWillow Biologics®, a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for BW-1010, the company's next-generation anthrax vaccine candidate.

ALZHEIMER'S ASSOCIATION: Statement Biogen to Submit Aducanumab Results in Early Alzheimer's to U.S. FDA

On behalf of the more than 5 million Americans living with Alzheimer's and their family members, the Alzheimer's Association is encouraged to learn that Biogen will pursue regulatory approval from the FDA for the investigational drug aducanumab based on Phase 3 clinical trial results from the EMERGE and ENGAGE studies, and other related data, after finding a reduction of cognitive and functional decline in people taking the high dose.

Physicians committee wants FDA to require breast cancer warnings on cheese products

The Physicians Committee for Responsible Medicine (PCRM) has filed a petition with the U.S. Food and Drug Administration (FDA) that would require a warning label on all dairy cheese products warning about the potential increased risks of developing breast cancer.

FDA Update: September inspection citations

The U.S. Food and Drug Administration (FDA) inspects numerous facilities around the nation to ensure that they comply with current rules governing FDA-regulated products.

AMERICAN ASSOCIATION OF ORTHODONTISTS: California Passes Dental Law Regarding Self-Applied Orthodontic Treatments

On October 13, 2019, California Governor Gavin Newsom signed Assembly Bill 1519 into law, granting the California Dental Board continued authority to oversee and regulate dental services in the state.

FDA Health News