Washington — The Food and Drug Administration on Tuesday finalized a rule change that broadens availability of abortion pills to many more pharmacies, including large chains and mail-order companies. The Biden administration partially implemented the change last year, announcing it would no longer enforce a long-standing requirement that women pick up the medicine in person. … Read more
The surge in flu cases and Covid-19 infections this month, along with elevated levels of childhood respiratory syncytial virus, or RSV, infections has caused elevated demand for children’s over-the-counter cold and flu medications. The commissioner of the Food and Drug Administration said his agency is working with producers to improve supply but the current demand … Read more
In this photo illustration, PlanB one-step emergency contraceptive is displayed on June 30, 2022 in San Anselmo, California. Justin Sullivan | Getty Images The Food and Drug Administration is changing the informational packaging of the emergency contraceptive pill, Plan B One-Step, to clarify that it is not an abortion pill, the federal agency announced Friday. … Read more
Shares of Kala Pharmaceuticals surged Wednesday after the small biotechnology company announced a drug candidate for a rare eye disease. The Food and Drug Administration has accepted Kala’s investigational drug application for KPI-012, a potential treatment for persistent corneal epithelial defect, or PCED, the Arlington, Massachusetts-based company announced on Tuesday. Kala shares soared $9.45, or … Read more
Biotech stock BioMarin (BMRN) gapped above a buy point and is now trading in a buy zone. X On Wednesday, shares of BioMarin gapped up over 7% in strong volume and traded above a 92.86 buy point. When a stock gaps above a buy point, the buy zone starts from the first five-minute high on … Read more
The Food and Drug Administration just approved its most expensive drug ever — a hemophilia gene therapy from Carlisle Companies (CSL) and UniQure (QURE) — and QURE stock popped Wednesday. X The infusion is approved for hemophilia B patients currently on a prevention regimen called Factor IX therapy, or who have a history of potentially … Read more
Washington — U.S. health regulators on Tuesday approved the first gene therapy for hemophilia, a $3.5 million one-time treatment for the blood-clotting disorder. The Food and Drug Administration cleared Hemgenix, an IV treatment for adults with hemophilia B, the less common form of the genetic disorder which primarily affects men. Currently, patients receive frequent, expensive IVs … Read more
mekcar Philips (NYSE:PHG), which has been mired with recall of its respiratory devices, informed the the U.S. Food and Drug Administration (FDA) that its Respironics Trilogy ventilators reworked as a part of a June 2021 recall have two new potential issues. The FDA said on Nov. 17 that the first issue was that the new … Read more
By Cara Murez HealthDay Reporter FRIDAY, Nov. 18, 2022 (HealthDay News) — It might be tempting to buy prescription medication online, but buyers should beware, the U.S. Food and Drug Administration warns. While some pharmacy websites operate legally and can offer convenience, privacy and lower costs, others may be selling unapproved, counterfeit and unsafe medications, … Read more
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