The FDA will regulate Recombinetics' biotech hornless cows after the agency clarified that it could regulate any altered portion of an animal's genome as an animal drug. The firm used a gene-editing technique called TALENs for dehorning the cattle.
A new designation category has been introduced by the FDA to allow drugs to be eligible for approval under a regenerative advanced therapy status. Drugmakers can apply for the designation if their treatment is a human cell and tissue product, therapeutic tissue engineering product, cell therapy or combination product intended to treat, reverse, modify or cure a serious or life-threatening condition or disease, with clinical evidence indicating that it can address unmet medical needs for the condition.
Concert Pharmaceuticals' CTP-656, or deuterated ivacaftor, has been granted orphan drug status by the FDA as a treatment for cystic fibrosis in patients with gating mutations. The drug is being studied under a midstage trial, with results expected by year-end.
An Oncology Center of Excellence has been established by the FDA as part of the national Cancer Moonshot initiative. Office of Hematology and Oncology Products Director Richard Pazdur has been named director of the oncology center.
Aurobindo's generic version of Micardis HCT tablets, or telmisartan and hydrochlorothiazide, has been approved by the FDA to treat hypertension. The generic will be available in three dosage strengths.
Robert Califf stepped down as FDA commissioner on Friday as President Donald Trump took office. Stephen Ostroff, the agency's current commissioner for the Office of Foods and Veterinary Medicine, could fill the interim post, but Trump is reportedly considering two Silicon Valley executives as candidates for the position.
Gilead Sciences' marketing authorization application for a daily single-tablet regimen of sofosbuvir, velpatasvir and voxilaprevir has been accepted for review by the European Medicines Agency. The drug combination is designed to treat chronic hepatitis C virus infection.
Mountain View Packaging is recalling more than half a ton of "@ease" brand Sweet Chili Chicken Meal Starter products in seven states due to the presence of the undeclared allergens milk, eggs and wheat. The items affected by the recall have a "best by" date of May 17, 2018, the UPC number 36800-38348 and the establishment number EST. P-39904.
European regulators have given Advanced Cooling Therapy CE mark approval for its Esophageal Cooling Device for use with the Altrix Precision Temperature Management System from Stryker. The device comes with an enclosed three-tube system inserted into the esophagus for controlling a patient's temperature.
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