The high throughput test will be available in the Fall with next-day turnaround time and will enable Helix to scale its capacity to 100,000 tests per day
The U.S. Food and Drug Administration issued a final rule to establish compliance requirements for fermented and hydroly
With HITRUST CSF Certification, SOC 2 compliance and an FDA-listed medical device, SWORD Health demonstrates its commitment to clinical-grade standards of patient security, safety, and privacy.
Kazia Therapeutics Limited (ASX: KZA;NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is pleased to announce that the United States Food and Drug Administration (FDA) has awarded Rare Pediatric Disease Designation (RPDD) to Kazia's paxalisib (formerly GDC-0084) for the treatment of Diffuse Intrinsic Pontine Glioma (DIPG), a rare and highly-aggressive childhood brain cancer.
The U.S. Food and Drug Administration is announcing that the manufacturers of certain per- and polyfluoroalkyl substances (PFAS) used for grease-proofing in paper and paperboard for food packaging (for example, as coatings on some fast-food wrappers, to-go boxes, and pizza boxes) have voluntarily agreed to phase-out their sales of these substances for use as food contact substances in the United States.
Expanded access is available to patients who are ineligible for enrollment in the FDA clinical trial of RLF-100, including pregnant women
Phase 1 Trial for the Treatment of Patients with Acute Lung Injury Due to COVID 19 Anticipated to Begin in Third Quarter of 2020
Agency Urges Consumers, Health Care Professionals Not to Use Certain Products, Citing Serious Adverse Events and Death
IND transfer clears path for Phase 2b trials of potential Peripheral Artery Disease (PAD) treatment and opens the door to explore other vascular applications
Access Genetics, LLC dba OralDNA® Labs announces that FDA has issued an Emergency Use Authorization for its OraRisk® COVID-19 RT-PCR test.
xMAP SARS-CoV-2 Multi-Antigen IgG Assay is enabled by xMAP Technology, the gold standard for multiplexing serologic testing
First FDA authorization of laboratory technique for use in COVID-19 diagnostic testing
New EverLift™ device designed to reduce costs and enhance complete polyp resections
Innovative Negative Pressure Wound Therapy Device for Surgical Incisions
Saladax is advancing personalized medicine by providing psychiatrists with the first commercially available antipsychotic test in the U.S.
Company Completes Critical Milestone in Development of "Universal Donor" Stem Cell Therapy for Stroke
As part of continued action to protect the American public, the U.S. Food and Drug Administration is warning consumers and health care professionals about hand sanitizer products containing methanol, or wood alcohol — a substance often used to create fuel and antifreeze that is not an acceptable active ingredient for hand sanitizer products and can be toxic when absorbed through the skin as well as life-threatening when ingested.