All posts tagged "Regulatorydrugapproval"

MIAMI — There's no big rush to get the new COVID-19 vaccine, according to health experts. Many patients are hesitant to get the shot for a variety of reasons, including vaccine fatigue, fear of side effects and the feeling that COVID is over. But there’s a new variant spreading, and public health agencies and many doctors say the new vaccine, which rolled out in November, can help keep people healthy during this holiday stretch of traveling and gathering. Pharmacies and the drug companies are aggressively pushing the new vaccines in ads and texts. Here’s what to know about the new COVID vaccin......

The U.S. Food and Drug Administration announced Wednesday that it had approved Narcan for over-the-counter, nonprescription use. The nasal spray becomes the first naloxone medication to be approved for these uses. Naloxone, when used in the right timeframe, can rapidly reverse an opioid overdose and is widely considered the standard treatment for opioid overdose. The spray will soon be available in drug stores, convenience stores, grocery stores and gas stations, as well as online. “Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locati......

KANSAS CITY, Mo. — Erin Morrow Hawley, an attorney and wife of one of Missouri’s senators, is at the center of a federal lawsuit in Texas that could cancel approval of a common drug used to terminate pregnancies, threatening abortion across the country. Hawley is one of the key lawyers fighting to end the Food and Drug Administration’s decades-old approval of mifepristone, one of the two drugs used in medication abortions, after the U.S. Supreme Court last year overturned Roe v. Wade. Hawley, an appellate attorney who was also involved in that case, is married to Republican Sen. Josh Hawley. W......

The U.S. Food and Drug Administration has approved a nasal spray developed by Pfizer as a means to quickly treat the painful symptoms associated with suffering a migraine. The drug, Zavzpret, also known as zavegepant, was approved on Thursday for the treatment of acute migraines with or without an aura in adults. It’s expected to launch in July, Reuters reported. “The FDA approval of Zavzpret marks a significant breakthrough for people with migraine who need freedom from pain and prefer alternative options to oral medications,” said Pfizer’s Angela Hwang, Chief Commercial Officer, President, G......