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(HealthDay)—The U.S. Food and Drug Administration on Friday approved the emergency use of a smaller dose of Pfizer’s coronavirus vaccine for children ages 5 to 11, paving the way for 28 million kids across the country to get their shots. These youngest Americans can now receive one-third of the adult dose, with two injections given […]
U.S. health regulators on Wednesday finalized stronger warnings for breast implants, including a new requirement that people receive detailed information about their potential risks and complications before getting them. The Food and Drug Administration announced the new regulations mainly aimed at implant manufacturers, who are also being required to add a boxed warning message—the most […]
FDA Approves Welireg (belzutifan) for the Treatment of Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors KENILWORTH, N.J.–(BUSINESS WIRE) August 13, 2021 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Welireg, an oral hypoxia-inducible factor-2 alpha […]
Fox News Flash top headlines for August 11 Fox News Flash top headlines are here. Check out what’s clicking on Foxnews.com. A group of researchers has called on the Food and Drug Administration to pull certain popular sunscreen brands after they said they’ve found evidence of a potential cancer-causing chemical. Craig Downs, executive director of […]
Pfizer says it plans to ask for FDA approval of its COVID-19 vaccine for children ages five to 11 by fall Pfizer Inc and its German partner BioNTech SE plan to ask for FDA emergency use authorization of its COVID-19 vaccine in children under age 12 by fall Dr Alejandra Gurtman, a Pfizer executive, said the […]
FDA Approves Ryplazim (plasminogen, human-tvmh) for the Treatment of Plasminogen Deficiency Type 1 LAVAL, QC and CAMBRIDGE, England, June 4, 2021 /CNW Telbec/ – Liminal BioSciences Inc. (Nasdaq: LMNL) (“Liminal BioSciences” or the “Company”) announced today that the U.S. Food & Drug Administration (FDA) has approved Ryplazim (plasminogen, human-tvmh) (“Ryplazim”) for the treatment of patients […]
Fox News Flash top headlines for May 27 Fox News Flash top headlines are here. Check out what’s clicking on Foxnews.com. The company behind an imaging agent meant to identify prostate cancer said it received FDA approval on Thursday for use in patients with suspected metastasis or recurrence. Lantheus Holdings, Inc. said its PYLARIFY injection […]
U.S. regulators have approved the first new drug in over a decade for children with ADHD, which causes inattention, hyperactivity and impulsivity. The Food and Drug Administration late Friday OK’d Qelbree (KELL’-bree) for treating attention deficit hyperactivity disorder in children ages 6 to 17. It comes as a capsule that’s taken daily. Unlike nearly all […]
KENILWORTH, N.J.–(BUSINESS WIRE) March 23, 2021 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to […]
CHICAGO (Reuters) – U.S. officials plan to use data gathered from people who have already been vaccinated against COVID-19 as well as data from ongoing clinical trials to determine when and whether current vaccines need to be updated to address viral variants. Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation […]