FDA announced Tuesday it has authorized second updated booster vaccines against COVID-19 for older adults and those with compromised immune systems. The bivalent vaccines target the Omicron variants of SARS-CoV-2. FDA said people who are aged 65 years and older who have not had a bivalent booster in at least 4 months can get another dose. For individuals with compromised immune systems, additional doses of the updated vaccine can be administered 2 months after the last dose. Additionally, FDA said people who are unvaccinated can receive a single dose of the bivalent booster. "COVID-19 continues to be a very real risk for many people," said Peter Marks, director of the Center for Biologics Evaluation and Research within FDA. "The available [...]

When Christopher Duke’s frail, elderly patient needed her blood pressure prescription refilled last year, she did what she always does — she called Duke, a physician in Chevy Chase, Md. No problem, Duke told her, he would call it in to a nearby pharmacy. But there was a problem — because Duke couldn’t get anyone to answer his calls. Instead, he ran up against a frustrating new reality at many drugstores, especially those in big chains: As essential jobs at retail outlets go unfilled, and hours are reduced at many chains, the likelihood of spotty service and potential mistakes at pharmacies has grown. When Duke called the pharmacy, its phone mailbox was full. He called the pharmacy again and requested [...]

The FDA on Wednesday approved Narcan, an opioid overdose reversal drug, to be sold without a prescription. The approval marks the first time any form of naloxone will be available without a prescription. The drug, which first received FDA approval in 1971, was originally an injection. The FDA approved the inhaled nasal spray version, more commonly known as Narcan, in 2015. It contains 4 mg of naloxone that can be sprayed into the nose like a common allergy medication. “Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country,” FDA Commissioner Robert Califf said in a statement. Emergent BioSolutions, which [...]

Earlier this month, Politico broke news that Walgreens, the nation’s second-largest pharmacy chain, assured 21 Republican attorneys general that it would not dispense abortion pills in their states should the company be approved to dispense them. The decision was met with sharp protest by Walgreens customers, abortion rights activists, and Democrats, who accused the pharmacy of caving needlessly to pressure. But fear of state prosecution is not the only factor shaping Walgreens’ decision-making. Another previously unreported constraint on the company is that its sole supplier of Mifeprex — the brand-name drug for the abortion pill mifepristone first approved by the Food and Drug Administration in 2000 — circulated a list to its corporate clients in January naming 31 states that it would not supply [...]

Pfizer reports that FDA has approved its drug zavegepant (Zavzpret) for the treatment of migraines. The nasal spray medication will be available in pharmacies in July, the company said. The drug contains a migraine inhibitor that works by impeding the release of proteins called calcitonin gene-related peptides. The drug was found to perform better than a placebo in relieving pain and certain symptoms, according to clinical trial results published in The Lancet Neurology. Trial participants who received zavegepant as a nasal spray were more likely to report returning to normal function within 30 minutes to 2 hours. The trial monitored 1,269 patients, of whom about one-half used the drug and the remainder received a placebo. Researchers examined how patients reported [...]