The FDA has given 510(k) marketing clearance to Gentherm Medical for its ASTOPAD, a patient warming system that is used during surgery to prevent or treat hypothermia.

A pilot program has been launched by the FDA's Center for Drug Evaluation and Research to characterize quality management maturity for finished dosage forms from local over-the-counter product and prescription drug manufacturers. The CDER also launched a second pilot program that will look at QMM for active pharmaceutical ingredients including drug substance intermediates made by foreign firms and intended for use in OTC products and prescription drugs regulated by the FDA.

The FDA is seeking information about D-tagatose, isomaltulose and similar sweeteners that are metabolized differently than traditional sugars in line with efforts to coordinate with manufacturers on the Nutrition Facts Label. The agency also stated that the Nutrition Facts Label will not categorize allulose as sugar or added sugar.

Orchard Therapeutics announced it had received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use gaining its recommendation for the approval of its investigational gene therapy Libmeldy to treat a rare genetic condition known as metachromatic leukodystrophy. A final decision is expected by year's end and its approval would make Libmeldy the first gene therapy and first commercial therapy for patients with early-onset MLD who are eligible for treatment.

A late-stage trial for a COVID-19 vaccine may begin next month in the Philippines if approved by regulators. China's Sinovac Biotech is one of several vaccines under evaluation by regulators there.

AbbVie and Genentech's Venclexta, or venetoclax, combined with either low-dose cytarabine or azacitidine and decitabine, was granted full approval by the FDA as a treatment for patients ages 75 or older with acute myeloid leukemia, or those not qualified for intensive induction chemotherapy because of comorbidities.

Bioelectronics firm iota is set to be purchased by Astellas after they entered a partnership last year for a research and development deal. Iota has developed technology using ultrasound to create miniature implantable medical devices that are battery-free and use wireless frequencies.

The biomass and volume of giant redwood trees in California have been measured using laser technology, according to researchers at the University College London. The technique offers first-ever insights into the trees' 3D structure, aiding scientists in estimating carbon absorption and possible climate change response, according to a study published in Nature Scientific Reports

The FDA has issued final guidance on biotin interference testing for in vitro diagnostic devices. The agency acknowledged industry recommendations but declined to lower the recommended biotin level for interference testing from 3,500 ng/mL to 1,200 ng/mL.

New York Gov. Andrew Cuomo and Arkansas Gov. Asa Hutchinson asked the Trump administration to provide more guidance on the logistics of mass COVID-19 vaccination, outlining questions involving funding, vaccine allocation and supply chain management. The leaders of the National Governors Association asked for a meeting with the administration to talk about the delineation between state and federal responsibilities and expectations for successful distribution of a COVID-19 vaccine.