Tag: approval

(Reuters) – The U.S. Food and Drug Administration (FDA) on Friday approved Bristol-Myers Squibb’s cell-based gene therapy, Breyanzi, to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or have relapsed after, at least two other types of systemic treatment. The FDA granted approval of Breyanzi for the treatment

FDA panel endorses Pfizer coronavirus vaccine When will the treatment be available to the public? Infectious disease expert Dr. Amesh Adalja provides insight. An advisory committee member said the Food and Drug Administration may decide on Pfizer’s coronavirus vaccine emergency use authorization application as early as Saturday. Dr. Paul Offit, who voted in favor of the

Fox News Flash top headlines for December 11 Fox News Flash top headlines are here. Check out what’s clicking on Foxnews.com. The U.S. Food and Drug Administration (FDA) is working toward quickly finalizing and issuing emergency approval for Pfizer and BioNTech’s coronavirus vaccine candidate, according to top FDA officials. “Following yesterday’s positive advisory committee meeting outcome regarding the

THURSDAY, Jan. 31, 2019 — The first generic version of the widely used Advair Diskus inhaler for asthma and chronic obstructive pulmonary disease (COPD) has won U.S. Food and Drug Administration approval. This approval “is part of our longstanding commitment to advance access to lower cost, high-quality generic alternatives,” said Dr. Janet Woodcock, director of

TUESDAY, July 17, 2018 — Pivotal trials supporting U.S. Food and Drug Administration approvals granted Breakthrough Therapy designation often lack randomization, double-blinding, and control groups, according to a research letter published in the July 17 issue of the Journal of the American Medical Association. Jeremy Puthumana, from the Yale University School of Medicine in New

The Food and Drug Administration on June 25 approved for the first time a drug made from cannabidiol (CBD), a molecule derived from the cannabis plant. The drug, Epidiolex, was approved for the treatment of two types of epilepsy, Dravet syndrome and Lennox-Gastaut syndrome, that have been resistant to treatment. Well-designed clinical trials have shown

The majority of patients eligible for cancer immunotherapy drugs known as checkpoint inhibitors received treatment within a few months of FDA approval, according to a new Yale-led study. The finding suggests that cancer immunotherapies are adopted at a much quicker pace than is typical for newly approved medical treatments, the researchers said. However, patients receiving

San Diego’s Dexcom has won regulatory approval for its latest continuous glucose monitoring system that eliminates the need for finger pricks and is nearly one-third smaller than its current wearable sensor for diabetes patients. The Food and Drug Administration this week gave the green light to Dexcom’s G6 system for delivering real time blood sugar